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http://www.pharmaceutical-technology.com/contractors/lab_equip/anachem/press42.html Wed, 07 May 2008 14:40:46 GMT http://www.pharmaceutical-technology.com/contractors/lab_equip/anachem/press42.html Adjustable Spacing Now Available on a Manual Multichannel Pipette The Economical Solution for increased poductivity when tansferring between sample formats Anachem is pleased to introduce a world's first, with the new RAININ Multi-Lite Adjustable Spacer Pipette. Ideal for routine micro-well applications, this totally unique pipette allows you to quickly and accurately change nozzle spacing for use with different storage formats. Transfer your samples with the greatest of ease between micro centrifuge tubes, 24, 48 and 96-well plates - just a twist is all it requires to change spacing. Previously, such functionality has only been available on more expensive electronic pipettes. Multi-Lite Adjustable Spacer incorporates the same performance and functional design along with operational features as the popular Multi-Lite Pipette. The patented LTS Lite-Touch Tip System provides highest security - tips seal precisely and consistent sample pick-up is guaranteed, every time. Enabling you to quickly change between different plate and tubing formats, this one of a kind pipette allows you to move the nozzle spacing between 9 and 14mm (8-channel) or 9mm - 19mm (6-channel). The Limiter dial sets the maximum, and the spacing adjustment control changes spacing quickly from minimum to maximum. Nozzle spacing is displayed in millimeters by the marks on the liquid end, and, due to the detent on the limiter dial, you can't over-space the nozzles - giving you peace of mind. Available in four models, 6-channel and 8-channel, both having 300ul and 1200ul nominal volumes, the Multi-Lite Adjustable Spacer features the proven LTS (LiteTouch) nozzles for faster tip loading and completely consistent sample loading. The liquid end rotates 360°ling quick alignment with the mother or daughter plate, with comfortable left or right-hand operation. http://www.pharmaceutical-technology.com/contractors/lab_equip/anachem/press41.html Wed, 07 May 2008 11:06:31 GMT http://www.pharmaceutical-technology.com/contractors/lab_equip/anachem/press41.html Protect Your Precious Samples with New 4titude(R) PlateStable(TM) Systems Safe Dry Storage for Sensitive Compound Libraries Now available from Anachem, the New 4titude® PlateStable™ system provides fully automated sample storage that maintains high quality compound libraries safely and effectively. PlateStable protects the integrity of solid and liquid samples by controlling the internal environment within its sealed, contaminant free enclosures. PlateStable contains one control module and a flexible number of containers that house SBS standard laboratory plates or tube racks. Different models offering a range of sizes and capacity accommodate individual requirements. The system is easy to use and operates simply by loading plates or tube racks into the enclosure, which is then sealed and connected to a control unit producing a short cycle that flushes out the existing oxygen atmosphere and replaces it with dry gas such as Nitrogen or Argon. Compounds in DMSO are kept in dry environments to minimise water uptake and damage caused by atmospheric oxygen. On completion of the flush cycle, the enclosure is disconnected from the control module and transferred to suitable storage facilities where it can remain for up to twelve months with its stabilised atmospheric conditions. The New PlateStable system has a monitoring system enabling users to analyse the contained atmospheric conditions at any stage during the length of the storage cycle. Exciting developments are also in progress to provide a solution for the storage of microarray slides. Anachem is the leading specialist distributor to the UK and Irish scientific communities with over thirty five years of technical expertise and innovation. Today, Anachem represents suppliers such as 4titude to provide world renowned liquid handling instrumentation, backed by unprecedented quality of service and support. http://www.pharmaceutical-technology.com/contractors/contract/boehringer/press7.html Wed, 30 Apr 2008 09:36:27 GMT http://www.pharmaceutical-technology.com/contractors/contract/boehringer/press7.html Landmark Trial Ontarget® Proves Telmisartan is as Protective as Ramipril and Better Tolerated in a Broad High-Risk Cardiovascular Population The results of the landmark ONTARGET Trial have proven that telmisartan, brand name MICARDIS, a modern Angiotensin II Receptor Blocker (ARB), is as protective as the current gold standard, ramipril, in reducing the risk of cardiovascular death, myocardial infarction, stroke, and hospitalisation for congestive heart failure in a broad cross-section of high-risk cardiovascular patients and with better tolerability. These cardiovascular events occurred in 16.66% of patients receiving telmisartan versus 16.46% of patients receiving ramipril. The relative risk (ratio of the probability of the event occurring in the telmisartan group versus the ramipril group) was 1.01, with a 95% CI of 0.94 -1.09. Telmisartan was also shown to be significantly better tolerated than ramipril, a widely used angiotensin converting enzyme inhibitor (ACE), with respect to typical ACE-inhibitor side-effects. Although patients with an ACE-inhibitor intolerance had been excluded from the trial, 359 patients in the ramipril treatment arm stopped their treatment because they experienced cough versus only 93 patients in the telmisartan arm. 25 patients stopped their treatment in the ramipril arm because of angioneurotic edema, versus only 10 in the telmisartan arm. The ONTARGET data also show that telmisartan is associated with a higher treatment compliance. Besides efficacy, tolerability and compliance are also important factors to consider as they are crucial for effective long-term treatment for the prevention of serious cardiovascular events. Telmisartan is now the only angiotensin II receptor blocker (ARB) to have proven cardio & vascular protective benefits beyond blood pressure reduction in this high-risk population.1 Until now, only the ACE-inhibitor ramipril had shown these protective effects. ONTARGET also studied the value of combining telmisartan with ramipril, to answer a key question for the clinical community - does combining an ACE inhibitor and an ARB, i.e. the dual Renin-Angiotensin System (RAS) blockade, offer even better protection compared to single blockade? The results announced today indicate that there is no additional protective benefit achieved for the overall patient population, if ramipril and telmisartan are combined. LARGEST ARB OUTCOME TRIAL EVER ONTARGET is a randomised, double-blind clinical trial, which evaluated 25,620 high-risk cardiovascular patients with normal or controlled blood pressure over an observation period of up to six years. "We are proud to have started ONTARGET, the largest outcome cardiovascular trial ever undertaken with an ARB. It included high-risk cardiovascular patients with a history of coronary heart disease, stroke, transient ischaemic attack, peripheral vascular disease or diabetes with target organ damage. The trial has an extremely robust data base that will enable the medical community to answer questions where no scientific proof was available before. With 99.8% of patients followed over these years, this is one of the best managed landmark trials ever. We owe this excellent management of the trial to the investigators in over 700 centres across 40 countries led by Professor Salim Yusuf and his team at McMaster University, Hamilton, Canada," said Dr Andreas Barner, Member of the Board of Managing Directors of Boehringer Ingelheim, responsible for research, development and medicine. http://www.pharmaceutical-technology.com/contractors/contract/boehringer/press6.html Wed, 30 Apr 2008 09:26:52 GMT http://www.pharmaceutical-technology.com/contractors/contract/boehringer/press6.html Boehringer Ingelheim Outpaces the Market yet Again in 2007 Boehringer Ingelheim enjoyed continued success through 2007, its growth outpacing the pharmaceuticals market for the eighth time in succession. As the Company announced at its annual press conference in Ingelheim, turnover rose by +8.8% in local currency (+3.6% in euro terms) to almost &uro;11 billion (2006: &uro;10.5 billion). At &uro;2.1 billion, operating income - comparable to the EBIT - is at the previous year's level. This corresponds to an operative margin (ratio of operating income to net sales) of 19.2%. Income after tax was a good &uro;1.8 billion, signifying an increase of +4.8% over the previous year. The number of employees worldwide rose by almost 1,400 to around 39,800 (an increase of +3.6%). According to calculations by the healthcare information service, IMS, Boehringer Ingelheim grew by +7.1%, thus once again outpacing the pharmaceutical market which experienced growth of +6.0%. In 2007, Boehringer Ingelheim again secured a stable market share of almost 2%, ranking 15th among the international pharmaceutical companies. BOEHRINGER INGELHEIM'S BUSINESS AREAS Business in the most important strategic business area, Human Pharmaceuticals, Prescription Medicines accounts for 79% of the total net sales of Boehringer Ingelheim. Here, net sales rose in 2007 by almost +10% in local currency terms (+4.2% in euro terms) to over &uro;8.6 billion, following adjustment to take account of the currency component. The self-medication business increased by +11.7% in local currency terms (+7.2% in euro terms) to &uro;1.14 billion. Total net sales of the Industrial Customer business(Biopharmaceuticals, Pharmaceuticals Production and Pharma Chemicals) amounted to EUR 739 million. The growth of Boehringer Ingelheim in 2007 was evident in all three regions. Last year, North and South America was again the region with the strongest turnover of the company, where net sales exceeded EUR 5.4 billion (2007: EUR 5.3 billion). In spite of stagnating development in euro terms, the USA remains the principal driving force for growth and, with its net sales of &uro;4.5 billion (approx. +12% in local currency terms), made the largest contribution to global net sales and profits. The strongest growth amongst the regions was achieved in Europe with net sales of &uro;3.6 billion (+ 8.6% in local currency terms) and a share of total net sales of just under 33%. The strongest country in this region was once again Germany with total net sales of &uro;853 million, although prescription medicines accounted for only &uro;444 million of this figures. http://www.pharmaceutical-technology.com/contractors/materials/dsm/press5.html Tue, 29 Apr 2008 16:06:41 GMT http://www.pharmaceutical-technology.com/contractors/materials/dsm/press5.html DSM Nutritional Products Increases Price of all Fat Soluble Vitamins by a Minimum of 10% for all Food, Pharma & Personal Care Industries DSM Nutritional Products announces a global price increase for all fat soluble vitamins. After recent price increases announced for Vitamin E and A the remaining fat soluble vitamins in the portfolio - K1, Natural Source Vitamin E, Mixed Tocopherols and Vitamin D3- will now also increase in price for all newly contracted business. The increase is effective for all qualities of these vitamins marketed in the human nutrition and personal care industries and will amount to a minimum of 10%. The price increase is necessary due to significantly higher costs of raw materials, energy and transportation and due to higher demand for DSM quality vitamins. http://www.pharmaceutical-technology.com/contractors/process_automation/schenck/press5.html Tue, 29 Apr 2008 15:06:32 GMT http://www.pharmaceutical-technology.com/contractors/process_automation/schenck/press5.html Schenck Process Group Honoured with the Oliver Wyman Best Growth Award for Mechanical Engineering Companies Schenck Process is the best example of the successes a good strategy process can deliver. In recognition of the successful definition and ongoing realisation of its growth strategy, the Schenck Process Group are delighted to announce that management consults Oliver Wyman and the Produktion business journal have conferred their 2007 Strategy Award for Mechanical Engineering Companies in the category of 'Best Growth Strategy' on the Schenck Process Group. Citing ability to achieve targeted financial results, in presenting the award Oliver Wyman acknowledges Schenck Process' transition from a component supplier to a leading provider of complete solutions. "The focus lies on the production of key components and on solutions with a clear differentiation and high customer benefit," says Thomas Kautzsch, Partner at Oliver Wyman in Munich. Additionally, selective acquisitions as well as the exemplary growth of its service business further convinced the awarding jury. The defined growth strategy, which Schenck Process has pursued since its 2005 MBO from Duuml;rr (owners of Carl Schenck AG) has greatly contributed to the award winning development of the company. Operating across the globe via a network of 25 legal entities, in order to achieve a focussed approach across various industries, the company has structured its business into five core International Business Segments (IBS) namely IBS Heavy, IBS Light, IBS Mining, IBS Power and IBS Transport Automation, each focusing on different user markets e.g. cement, steel, food, pharmaceuticals, coal, base metals, power and transport automation processes for road, rail and port. Serving all of these industries and many more via a customer-orientated business model, Schenck Process develops, manufactures and markets a full range of solutions, products and turnkey systems on the basis of combining process engineering expertise, reliable components and field-proven technology. Special praise was also given to the exemplary expansion of Schenck Process' services with respect to process optimisation for customers and carefully planned inorganic growth. Specific acquisitions e.g. the Stock, Redler and Fairfield companies and the 'in-motion-scale' business of Pfister Waagen Bilanciai, have increased the operating result at Schenck Process by 340% since 2003 and resulted in a 120% increase in the workforce; in Fiscal Year 2007, Schenck Process employed approximately 2,000 staff worldwide. Stewart D Murdoch, Schenck Process' Director of Business Development & Marketing comments, "we strongly believe in having a customer-orientated business model and we place this at the centre of all of our activities. Building on this model, the objective of our strategy is to have a balanced and profitable growth based on clearly defined organic and inorganic actions with the overarching objectives being the leverage of our global footprint to maximise our pre and after sales support and further expansion of our market position internationally." With more than 2,900 professionals in over 40 cities around the globe, Oliver Wyman is one of the leading management consulting firms and is part of the Marsh & McLennan Companies. The "Strategy Award for Mechanical Engineering Companies" was started in 2005 with the aim of encouraging development of strategic goals in the industry and publicly recognising their implementation. More than 100 German, Austrian and Swiss mechanical engineering companies participated in the contest that was conducted in co-operation with the business journal Produktion and under the patronage of the German Federal Ministry of Economics and Technology. http://www.pharmaceutical-technology.com/contractors/lab_equip/anachem/press40.html Thu, 24 Apr 2008 10:46:10 GMT http://www.pharmaceutical-technology.com/contractors/lab_equip/anachem/press40.html Online Catalogue Helps You Find Products Faster Simple product navigation on new Anachem website Anachem's new enhanced website has been dramatically re-developed to provide a faster and more effective tool that enables customers to find products they need at the click of a button. The highly advanced search facilities have been greatly refined to allow users to filter through the cleverly structured product catalogue or search by keyword, whole or partial part number to quickly locate specific product information. The homepage presents a comprehensive list of categories that defines the product type and application area. These are also represented by horizontal page tabs directing users to the required product catalogue areas. Once deciding and clicking on the category of interest, users are immediately directed to further listings of sub categories. These are accompanied by a short introduction to that particular product group and an image that help to further identify the products that you wish to find. Each category may be divided by application, type, brand, packaging or simply by relevance or association. Certain products appear in multiple listings to accommodate a multitude of user definitions for the product eg. Gilson racked filter tips can be found in the listing for racked tips, filter tips and sterile tips. A full list of qualifying products with part numbers, stock status, descriptions, detailed technical information and images is presented at the end of each filter, allowing users to make an informed decision before purchasing that item. Each product may then display possible alternative or associated products including accessories, helping you to save even more time finding all the products required. In addition to the product catalogue listing search, the keyword and part number search facility is always readily accessible at the top of each page and enables users to create a more specific and direct search depending on the keyword or part number used. An illustrated list is generated displaying all products relevant to the search criteria. http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press5.html Wed, 23 Apr 2008 16:02:43 GMT http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press5.html Unigene Successfully Completes Phase I/II Clinical Study for Oral Calcitonin Unigene Laboratories has successfully completed the Phase I/II oral calcitonin clinical study that it initiated last month. This study, which achieved all of its planned objectives, primarily measured the ability of Unigene's proprietary oral delivery technology to significantly reduce the levels of an established biochemical marker that correlates with bone loss. All of the twenty-two subjects who completed the study demonstrated a robust reduction in this marker. In addition, the study demonstrated a dose-dependent increase in calcitonin blood levels. This is the second successful clinical study that the company has conducted using its improved oral calcitonin formulation. In October of last year, Unigene reported that all of the subjects in its first study achieved a biological response and that the goals for blood levels and variability were met. Those results will be reported next month at the Eighth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis. "The extremely significant findings of this study should enable us to select the optimal oral calcitonin dose that will be carried forward in the program," commented Dr Ronald S Levy, Executive Vice President of Unigene. "This achievement strongly advances our calcitonin development efforts and should facilitate the partnering activities that we are pursuing in parallel. It also confirms the importance of the delivery technology modifications that we have developed and optimized over the past year, which improve performance while simplifying the tablet manufacturing process. Finally, these improvements should provide the basis for additional intellectual property that will strengthen our patent portfolio and should improve the performance of our delivery platform for virtually any peptide that would be a suitable candidate." http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press4.html Wed, 23 Apr 2008 15:45:27 GMT http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press4.html Unigene Announces Publication of Initial Results of Site-Directed Bone Growth Studies Unigene Laboratories reported that the results of animal studies confirming the ability of its novel technology to rapidly form and maintain natural bone growth at targeted locations has been published. The paper, entitled "Replacement of Bone Marrow by Bone in Rat Femurs: The Bone Bioreactor," summarizes the early-stage collaborative work performed by researchers at Yale University School of Medicine and Unigene, and appears in the most recent edition of the journal Tissue Engineering. The paper evaluated the effect of bone marrow removal from targeted sites followed by different schedules of daily injections of anabolic agents such as parathyroid hormone (PTH). The procedure created new bone tissue that appears structurally and biologically normal and demonstrated improved biomechanical properties. The combination of bone marrow removal and anabolic therapy resulted in new bone formation at a rate and to an extent that could not be achieved with anabolic agents alone. Additional studies that extend the results of this work in different animal models are ongoing. These studies should provide further evidence that the newly formed bone can be preserved over a long period of time, and will be described in future publications. "This technology could radically change the way patients are currently treated for weakened or fractured hips, vertebrae and acute traumatic long bone fractures," stated Dr Agnes Vignery, principal investigator at Yale University and senior author of the publication. "Physicians currently treat such conditions using invasive techniques that require operating room time, utilize artificial materials, and result in imperfect outcomes. The ideal approach would be to create new bone where it is needed and at a faster rate." "The goal of this program is to develop a simple, minimally invasive outpatient procedure in conjunction with the administration of one or more drugs that can lead to the growth of new, structurally normal bone in precisely targeted locations," said Dr. Warren Levy, President and CEO of Unigene. "If we are successful in the human studies that are planned, patients will have an inexpensive alternative to spinal fusion, vertebroplasty, total joint replacement or the insertion of metal or plastic supports that will strengthen specific bones naturally. These are major commercial opportunities and we have been told by leading experts in the medical community that there is a great need for new approaches to treat these conditions." Tissue Engineering is an authoritative, peer-reviewed journal that explores the application of engineering to biological tissues, with the goal of developing biological approaches to treat pathological conditions. http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press2.html Wed, 23 Apr 2008 15:40:59 GMT http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press2.html Unigene and Shijiazhuang Pharmaceutical Group to Expand Chinese Joint Venture Unigene Laboratories announced plans to broaden the activities of its joint venture with the Shijiazhuang Pharmaceutical Group ("SPG") and to expand the potential product line to be developed and marketed by the joint venture. Unigene and SPG plan to establish the SPG-Unigene Biotechnology Research Institute in China. The Institute will continue ongoing registration activities for Unigene's calcitonin products, develop biopharmaceutical manufacturing facilities compliant with US current Good Manufacturing Practice guidelines, and establish and supervise the creation of a new pharmaceutical distribution network for joint venture products in China, all to take advantage of the world's largest osteoporosis market. Unigene Laboratories reports that a comparative analysis of various osteoporosis therapies has been published, concluding that there is insufficient evidence to support claims of superior effectiveness among the drugs reviewed. The study, commissioned by the Agency for Healthcare Research and Quality, Department of Health and Human Services, is entitled The Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis. The study was performed by the Southern California/RAND Evidence-based Practice Center to assist physicians, patients, private- and public-sector organizations in making informed decisions about pharmaceutical alternatives for osteoporosis and reviewed data for bisphosphonates, calcitonin, parathyroid hormone, estrogen, selective estrogen receptor modulators and testosterone. The leading category of osteoporosis drugs is the bisphosphonates, with established efficacy in reducing fractures in osteoporosis patients. However, according to the report, not enough scientific evidence exists to establish whether bisphosphonates are better at preventing fractures than calcitonin, estrogen or raloxifene. Additionally, certain bisphosphonates have been associated with osteonecrosis. Separately, the FDA is currently conducting a safety review of all bisphosphonate products and their possible link to atrial fibrillation, an established risk factor for stroke. Findings in the report cite evidence that calcitonin has also demonstrated a reduction in fracture risk among post-menopausal women as well as men. The global history of calcitonin products demonstrates an impressive safety profile, with products being administered to patients for more than 35 years with virtually no significant side effects. Calcitonin is the active ingredient in Fortical®, a nasal calcitonin product developed by Unigene and marketed by Upsher-Smith laboratories. "The study suggests that many of the available products are effective in treating osteoporosis sufferers, yet there is little evidence to support differentiation of the products based on effectiveness," commented Dr. Warren Levy, President and CEO of Unigene. "The study also indicates that adherence to the therapy is an important factor in patient outcome. We hope that this study will encourage physicians and patients to recognize that, if there are acceptable alternatives for patients with osteoporosis or low bone density, and long-term therapy is desirable, then the side effect/safety profile of each drug should be considered carefully before treatment decisions are made." Unigene will maintain its 45% ownership position in the joint venture. The combined capital investment commitment for the joint venture will remain at $15 million. Unigene's initial cash contribution to the joint venture will remain at US$900,000, which will be paid by Unigene upon the satisfaction of certain conditions, while the majority, or possibly all, of its remaining contribution will be in the form of technology. "The creation of the Institute should allow for the addition of potential new revenue-generating products and programs to our joint venture distinct from calcitonin, thereby expanding our commercial opportunities in China," commented Dr Warren Levy, President and CEO of Unigene. "The formation of the Institute will allow us to take advantage of the rapidly growing market potential for biotechnology products in China, to apply for government funds to support joint venture programs and to more fully utilize the additional resources available as a result of the acquisition of SPG by a private equity fund led by Legend Holdings and Goldman Sachs, which occurred in August of 2007." http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press3.html Wed, 23 Apr 2008 15:35:21 GMT http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press3.html Boning up on New Osteoporosis Risk Guidelines Osteoporosis - a skeletal disease that traditionally affects those age fifty and older - is a major public health problem. New guidelines released by the National Osteoporosis Foundation (NOF) call for bone mineral density (BMD) testing for all men ages seventy and older and for younger men with risk factors for bone loss. BMD testing is also urged for women sixty-five and older, and postmenopausal women that have risk factors for bone loss. "These guidelines represent the newest advances healthcare professionals can use to identify and treat patients with low bone mass, risk of fracture, or osteoporosis," says noted expert Dr. Warren Levy, President and CEO of Unigene Laboratories. "As life expectancy rates continue to rise, osteoporosis will only have a greater impact on national health. The NOF guidelines will help physicians to diagnose and treat the disease." Osteoporosis occurs when deteriorating tissue reduces bone density in the spine, hip, and other areas. Today, osteoporosis is a major health threat for forty-four million Americans, 80% of whom are women. In the United States, ten million individuals already have the disease while three times as many are believed to have osteopenia, a decrease in bone mineral density that can be a precursor condition to osteoporosis. Fractures caused by either osteoporosis or low bone density can lead to chronic pain, disability, or worse. Fortunately, if osteoporosis does develop, various treatments are available. The leading category of osteoporosis drugs is bisphosphonates, non-hormonal drugs that bind to bones to protect against tissue breakdown. However, recent reports have associated bisphosphonates with osteonecrosis ("bone death") of the jaw, severe bone/joint pain and potentially severe gastrointestinal side effects. Alternative drug treatments for reduction in fracture risk do exist such as: calcitonin, parathyroid hormone, estrogen, and testosterone. Calcitonin is the active ingredient in Fortical, a nasal treatment developed by Unigene and marketed by Upsher-Smith Laboratories. "Nasal calcitonin products have been shown to help maintain proper bone density," says Dr Levy. While until now, the medical community had no clear guidelines for assessing fracture risk, Dr. Levy believes the new NOF guidelines will help to educate the public and medical community on the prevention and treatment of osteoporosis. "As in most things," says Dr Levy, "education is a strong first line of defense." http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press1.html Wed, 23 Apr 2008 15:24:27 GMT http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene/press1.html Unigene States that New Government Study Reports Many Osteoporosis Medications Prevent Fractures, but None is Proven Best Unigene Laboratories reports that a comparative analysis of various osteoporosis therapies has been published, concluding that there is insufficient evidence to support claims of superior effectiveness among the drugs reviewed. The study, commissioned by the Agency for Healthcare Research and Quality, Department of Health and Human Services, is entitled The Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis. The study was performed by the Southern California/RAND Evidence-based Practice Center to assist physicians, patients, private- and public-sector organizations in making informed decisions about pharmaceutical alternatives for osteoporosis and reviewed data for bisphosphonates, calcitonin, parathyroid hormone, estrogen, selective estrogen receptor modulators and testosterone. The leading category of osteoporosis drugs is the bisphosphonates, with established efficacy in reducing fractures in osteoporosis patients. However, according to the report, not enough scientific evidence exists to establish whether bisphosphonates are better at preventing fractures than calcitonin, estrogen or raloxifene. Additionally, certain bisphosphonates have been associated with osteonecrosis. Separately, the FDA is currently conducting a safety review of all bisphosphonate products and their possible link to atrial fibrillation, an established risk factor for stroke. Findings in the report cite evidence that calcitonin has also demonstrated a reduction in fracture risk among post-menopausal women as well as men. The global history of calcitonin products demonstrates an impressive safety profile, with products being administered to patients for more than 35 years with virtually no significant side effects. Calcitonin is the active ingredient in Fortical®, a nasal calcitonin product developed by Unigene and marketed by Upsher-Smith Laboratories. "The study suggests that many of the available products are effective in treating osteoporosis sufferers, yet there is little evidence to support differentiation of the products based on effectiveness," commented Dr. Warren Levy, President and CEO of Unigene. "The study also indicates that adherence to the therapy is an important factor in patient outcome. We hope that this study will encourage physicians and patients to recognize that, if there are acceptable alternatives for patients with osteoporosis or low bone density, and long-term therapy is desirable, then the side effect/safety profile of each drug should be considered carefully before treatment decisions are made." http://www.pharmaceutical-technology.com/contractors/lab_equip/anachem/press39.html Wed, 16 Apr 2008 12:18:58 GMT http://www.pharmaceutical-technology.com/contractors/lab_equip/anachem/press39.html Screentape Allows Rapid Analysis of Mycoplasma PCR Reactions for Efficient Screening of Cultured Cell Lines The ScreenTape system, developed by Lab90 and distributed by Anachem, employs a unique microscale polymer tape that contains all the reagents required for DNA electrophoresis. It brings major advantages of convenience, ease of use and safety to molecular biologists as absolutely no handling of gels and buffers is required. The compact, fully automated ScreenTape instrument replaces the need for hand-cast gels, buffers, gel tanks and gel-doc systems. In just under ten minutes the system loads the samples, runs the gel, images and presents the fully analysed results (including gel picture, band sizes and quantitative data).This ensures accuracy, reproducibility and traceability. The system is fully bar-coded to meet GLP guidelines and data is archived for easy retrieval and comparison. The ScreenTape system streamlines PCR screening of tissue culture S/N for Mycoplasma spp. Lengthy gel electrophoresis analysis is replaced with a 10 minute, automated, hands-free analysis step without any reagent or gel preparation. GLP cell line results are immediately archived thanks to the tailored GeneTools software. Mycoplasma are microorganisms that commonly infect cells in tissue culture, potentially leading to spurious experimental results, the loss of crucial data and unplanned costs. Laboratories routinely use Mycoplasma specific PCR to screen cultures for these contaminants and the resulting DNA fragments are analysed by gel electrophoresis. The Lab901 ScreenTape system is a novel, automated method for mycoplasma PCR analysis. MATERIALS AND METHODS USED IN PCR For each cell line, 100μl of tissue culture S/N from transfected Chinese Hamster Ovary cells (CHO cells) was boiled for 10 minutes. Using the instructions from the Minerva Biolabs¨ Mycoplasma PCR kit, reactions were set up in thin walled 0.2ml tubes. SCREENTAPE DNA ANALYSIS PROCEDURE Samples from the PCR block were mixed 1:4 with Lab901 loading buffer and placed in the TapeStation with ScreenTape D800. After clicking 'START' on the software driven menu, full analysis of the samples was achieved and archived, with no user intervention, within 10 minutes. RESULTS Analysed results are visualised immediately, highlighting band sizes for each of the PCR reactions. Samples in lanes 3 (positive control), and 5 show fragments of 182 and 269bp, that are diagnostic of Mycoplasma infection, whereas samples in lanes 2 (negative control) and 4, that only show a band at 182bp, are free of infection. ADVANTAGES OF USING SCREENTAPE FOR MYCOPLASMA PCR ANALYSIS The ScreenTape system allows significant time saving for Mycoplasma PCR analysis, by providing a fully automated, walk-away solution. No reagent preparation is needed and the use of Ethidium Bromide is eliminated. Data on the presence or absence of Mycoplasma for each cell line is automatically archived and easily retrieved. GLP-grade reports can be saved and printed following a one-click procedure. Anachem is the leading specialist distributor to the UK and Irish scientific communities with over thirty five years of technical expertise and innovation. Today, Anachem represents suppliers such as 4titude, GE, Gilson, Lab901, Munktell, Rainin, SSI and Treff, to provide world renowned manual liquid handling products, plastics and consumables backed by unprecedented quality of service and support. http://www.pharmaceutical-technology.com/contractors/process_automation/schenck/press4.html Tue, 15 Apr 2008 16:22:36 GMT http://www.pharmaceutical-technology.com/contractors/process_automation/schenck/press4.html Schenck Process Opens New TestCenter Which feeder is best for which bulk material? In order to provide customers with accurate answers to this question, Schenck Process are now offering tests at their new, modern TestCenter in Darmstadt that are based on real life situations. The specialist in measuring and process technologies invited its customers to the centre's official opening on 27 February. More than 100 people attended the event to learn more about what the new centre has to offer. Just like at a trade fair, the event enabled them to view several highlights under one roof. More test rigs and an improved level of automation mean that the TestCenter can now run even more accurate tests, all very closely based on actual processing circumstances. JUST LIKE REAL LIFE Tests in the four test labs can be run in parallel without impacting negatively on one another. Three of the test labs feature different equipment for filling the feeders with bulk bags or pneumatic feeding and complete cycle feeding. The fourth lab can be heated in a way that simulates different ambient conditions and can even simulate the environments of hot climates. All this means that the test processes undertaken are very simple to run. For example, the centre includes: Separate dust separation Separate preparation for tests in the PowderArea The test bulk material used being stored locally Liquid cleaning of dirty feeders and equipment in the FeederWash with dirty water collection pan body and eye wash units that satisfy the latest safety standards Customers can also benefit from the test tower where bulk material can be supplied directly from the street. This features three different bulk material test areas: A material circuit with pneumatic cycle feeding for dust or carbon dust with MULTICOR® S40 A granulate test area with MULTISTREAM® A MULTIDOS® test area NO NEED TO GET YOUR HANDS DIRTY The new spatial concept satisfies very stringent cleanliness and safety standards. Work in the old test centre was often rather dusty but now the tests can be followed from screens in the separate, dust-free control room. The highly functional way in which the centre is split into a test, control and meeting area also allows meetings to be held alongside the tests or for specialist meetings to be held right next door - and those nice shiny suits can stay that way. Portable PCs with wireless connections can be used throughout the TestCenter. Food and drink can of course also be arranged. During the opening event, interested parties were able to follow various tests in person. These included for example feeding PP granulate using the MechaTron® and processing Finntalc with the ProFlex® C. As well as the ProFlex®, guests could take a look at the PureFeed®, MULTIDOS® L and MULTIGRAV® EasyClean. The visitors explored all the different parts of the TestCenter and many took the opportunity to also tour the final assembly area. http://www.pharmaceutical-technology.com/contractors/process_automation/vaisala/press9.html Wed, 02 Apr 2008 15:08:05 GMT http://www.pharmaceutical-technology.com/contractors/process_automation/vaisala/press9.html New Generation Vaisala HUMICAP Relative Humidity Sensor Vaisala has introduced a new generation Vaisala HUMICAP® relative humidity sensor, the Vaisala HUMICAP 180R used in Vaisala industrial humidity transmitters. This new type of capacitive humidity sensor has been developed especially to cope with chemical interference. In most humidity measurement applications, the sensors are also exposed to chemicals other than water vapor. Such vapors are present in most environments, even in normal office air. As the responses to some gases and vapors are very slow, in many cases several weeks or months, the effects are often described as 'drift' or 'aging' of the sensor and not as chemical interference. The resistance of the Vaisala HUMICAP 180R to chemical interference has been achieved by developing a new type of chemical resistant polymer and a special new structure. The structure slows down the migration of adverse chemicals, or completely prevents them, from entering the active polymer layer. The chemical resistant active polymer further contributes to the stability of the sensor, making it the recommended Vaisala sensor for relative humidity measurement. The new Vaisala HUMICAP sensor has been tested both in laboratory conditions as well as in typical humidity sensor applications. The sensors perform better both in laboratory high chemical concentration tests as well as in long-term field stability tests. The results show that the new polymer makes the sensor highly resistant to chemical interference and therefore provides improved long-term stability for the relative humidity measurement. http://www.pharmaceutical-technology.com/contractors/process_automation/pharmagel Wed, 07 May 2008 00:00:00 GMT http://www.pharmaceutical-technology.com/contractors/process_automation/pharmagel Pharmagel Engineering S.P.A Pharmagel Engineering develops Softgel Technology for pharmaceutical, nutraceutical and cosmetic products. SOFTGEL The softgel (soft gelatine) capsule is a one piece, hermetically sealed shell wall filled with oils and non-acqueos liquids, plus solids in a paste or solution form. The shell gives a unique strength and durability to softgels, and in addition protects the inner fill material from atmospheric oxidation that compromises other oral dosage forms in terms of potency and shelf life. Softgel has become widely used in prescription and OTC pharmaceuticals, plus also in nutraceuticals, because of the following advantages: Improved bioavailability Easier to swallow Better consumer confidence Elegant appearance Masks odours Longer shelf life Rapid action Easy and flexible formulation WHO ARE PHARMAGEL Pharmagel is the leading supplier of semi-turnkey softgel encapsulation plants worldwide, having been engaged in the research and development of encapsulation lines and the formulation of softgels for 4 decades. Pharmagel softgel encapsulation equipment is used in 24 countries on 5 continents. Many of the plants have been completely redesigned and supplied with technology and training by Pharmagel. This experience combined with our many decades of experience in the industrial production of softgels, enables Pharmagel to give clients a unique and unrivalled guarantee of industrial manufacturing success in their own markets. The Pharmagel range of softgel encapsulation lines and ancillary equipment, combined with Pharmagel's technology and knowledge of the worldwide softgel market, offers clients a service of unrivalled quality and capability. That is especially important with the increasing use of softgels over the past two decades in the pharmaceutical, nutraceutical, cosmetic and leisure industries. SOFTGEL ENCAPSULATION LINE The MK3 range of Softgel lines represent a new generation of rotary die encapsulation machines designed to comply with international GMP and with the capability to make all capsule types, with a performance capability of up to 450 million softgels per year (typical 7.5 minim oval size). PHARMAGEL PRODUCTION PROCESS Fill and capsule base preparation - These two phases are the key for a successful encapsulation process. Using the example of the most complex fill type, complex pastes such as multivitamins /minerals or herbal extracts; these must be processed with proper specification mixing, refining and homogenising equipment and procedure, under vacuum. Particle size and viscosity are optimised for easy and accurate encapsulation. GMP equipment design with proven CIP (clean in place) systems is also vital to avoid cross contamination between products. Capsule base preparation is a critical process as it directly affects capsule shape, appearance and seam strength. Encapsulation and drying - Encapsulation is obviously the most critical phase for the production of a perfect softgel capsule batch. The rotary die process, which has been perfected by Pharmagel over 4 decades, is a continuous single operation, because with the rotary die process the softgel capsule is formed and filled in a single step under conditions of low humidity and accurately controlled temperature. Following encapsulation, softgels undergo drying - firstly fluid bed drying for approximately two hours followed by one to three days tray drying. Inspection - With pharmagel technology, batches require little inspection and sorting with Pharmagel automatic sorting machines specially designed to automatically inspect capsules at high speed and with minimal labour costs. PHARMAGEL SERVICES Pharmagel Guarantee - advanced technologies and equipment, GMP encapsulation plant design, accurate selection of capsule raw materials, intelligent choice of excipients, and experienced design of formulations. We outline below our project technology transfer services: ENGINEERING Preliminary Plant layout Design and drawing of a complete softgel manufacturing facility Detailed technical documentation Supply of all manufacturing, ancillary and analytical equipment Provide operation manuals and Sop's Supervise Plant design and equipment installation Installation qualification (I.Q.) and operational qualification (O.Q.) TECHNOLOGY New softgel capsule product formulation and manufacturing procedures Experimental trials Pilot batch production Stability tests. Product master files in accordance with the requirements of major international health authorities http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene Wed, 07 May 2008 00:00:00 GMT http://www.pharmaceutical-technology.com/contractors/drug_delivery/unigene Unigene Unigene is a biopharmaceutical company that delivers oral and nasal delivered peptide drugs for the global osteoporosis market. Our major products include nasal / oral salmon calcitonin - oral PTH analogs, oral glucose regulatory peptides, oral leuprolide, oral desmopressin and oral PYY(3-36) NH2. The company's patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support our worldwide commercialization strategy of oral and nasal therapeutics. Unigene's R&D work focuses on a range of pharmaceutical products and procedures including recombinant DNA technology, analytical and immunoassay test development, protein chemistry and more. Our cGMP manufacturing facility supports bacterial and mammalian fermentation, high-tech purification methodologies and analytical testing processes. BUSINESS ALLIANCES Unigene actively pursues ventures with a range of international pharmaceutical partners. Negotiations are in progress with the Chinese Shijiazhuang Pharmaceutical Group to commercialize injectable and nasal salmon calcitonin in China. Unigene has also secured an exclusive licensing agreement with Upsher-Smith Laboratories to market Fortical®, the patented nasal calcitonin formulation. Unigene also holds high-profile licensing agreements with GSK, Novartis and Upsher-Smith. We are currently developing several new products and awaiting US marketing approval for Unigene&squo;s lead product, Fortical® Nasal Spray. INJECTABLE CALCITONIN Unigene's injectable calcitonin is an important drug in the treatment of osteoporosis and currently commands a global market of $150 million. In 1998 Unigene obtained marketing authorization from the European Union to supply injectable calcitonin for the treatment of Paget's Disease and Hypercalcemia. In 2003 the drug was authrorized for the treatment management of osteoporotic fractures in 2003 and for Osteoporosis treatment in Switzerland. Injectable calcitonin is currently available for licensing in US and other markets (with the exception of China). ORAL DESMOPRESSIN AND LEUPROLIDE Oral desmopressin is used extensively in the treatment of primary nocturnal enuresis and possesses a potential worldwide market of approximately $200 million. Preclinical Studies into oral desmopressin have demonstrated the efficacy an of oral delivery application method. Unigene has developed oral leuprolide for use in the prostate cancer and endometriosis treatment market. With a projected worldwide market in excess of $1 billion, oral leuprolide is available for licensing in US and other international markets. GLUCOSE REGULATORY PEPTIDES AND ANALOGS Unigene's glucose regulatory peptides and analogs are used in the treatment of Type I and Type II diabetes, commanding a projected worldwide market in excess of $1 billion. We have developed a recombinant production methodology for the manufacture of our glucose regulatory peptides and analogs, and the success of the oral delivery practice has been verified by preclinical studies. PHARMACEUTICAL MANUFACTURING TECHNOLOGY The company's recombinant "direct expression" technology is used for the scalable and effective production of peptides and small proteins. Our cGMP manufacturing plant supports recombinant peptide production, in vitro amidation technology for peptides requiring c-terminal amidation for biological activity, oral peptide and small protein delivery technology and nasal delivery formulation for calcitonin and other peptides. http://www.pharmaceutical-technology.com/contractors/lab_equip/qed-scientific Fri, 02 May 2008 00:00:00 GMT http://www.pharmaceutical-technology.com/contractors/lab_equip/qed-scientific QED Scientific QED Scientific was established in 1997 to supply incubators, ovens and refrigeration equipment for the UK healthcare market. Since then the company has steadily expanded, firstly to include equipment for pathology and operating theatres and then to supply environmental chambers for industry and pharmaceutical quality-control laboratories. More recently QED Scientific has been supplying cabinets and enclosures that use carbon filters to control undesirable odours and these include everything from DNA fingerprint cabinets to standard bench fume hoods. We also offer site validation and mapping for all cabinets, both new and those already in your laboratory. The latest addition to the QED range has been the innovative range of VarioTemp hotplates/coldplates. These are the world&squo;s first easily portable multi workbenches and ovens for heating and cooling. HUMIDITY AND ENVIRONMENTAL CABINETS There are two standard ranges of environmental stability cabinet, depending on your needs. The SFC and LT base ranges are bench and floor models using ultrasonic humidity generators for optimum reliability and control. These models also have some de-humidifying capacity to ensure that they can easily maintain the humidity and temperature environment at or below ambient room temperature. These models can be fitted with a data output for logging on your PC. Capacities are between 150L and 1,275L. The advanced MMM range of humidity and environmental cabinets are floor-standing models and offer temperature and humidity control over a wide range. De-humidification well below ambient is standard on these as is the ability to store several ramp-and-dwell programmes that can be recalled as required. These models are all fully self-contained with water supply and drain reservoirs. All models offered have stainless steel chambers with both humidity and temperature independently controlled by microprocessor programmers. INCUBATORS AND OVENS Our UK-manufactured general purpose GP incubators and ovens are available in many sizes between 10L and 6,000L so there is sure to be one that suits your needs. They can be fitted with programmers and chart recorders if required. Whilst the incubators control over the range from 8°C above room temperature up to 100°C, the ovens have a top limit of either 250°C or 300°C. We are able to economically manufacture to user requirements and also to fit specialised ramp and dwell temperature programmers to any model. Cooled incubators control over the range between 5°C and 50°C with an accuracy of better than 0.5°C. Capacities range from 50L to 1,275L. Two versions are available, with economy models having plastic moulded interiors and advanced models with stainless steel chambers. The advanced CH chilled models feature Peltier environmentally friendly cooling that gives accurate cooled temperature control between 12°C and 60°C without the need for unfriendly cooling compressors. These chilled incubators are virtually silent and vibration free, so ideally lend themselves to many insect and crystal growth applications as well as general microbiology and life science uses. FUME FILTRATION CABINETS Many laboratories do not want fixed and ducted fume containment facilities, instead preferring to use fume cupboards with carbon filters to remove unwanted chemical odours. These Air Science fume cabinets can instead be fitted with HEPA filters if particulates are the problem that need removing. Whatever the problem, you can be assured of clean air. All fume filtration cabinets are whisper-quiet, making them very pleasant to work with. The range includes bench and floor models as well as more specialised cabinets for the safe storage of chemicals, enclosures that protect personnel when weighing powders, and the innovative range of forensic cabinets. DOWNFLOW CABINETS There are occasions when a downflow bench is to be preferred. We supply either DWS self-contained bench models with carbon filters, or floor mounted and fully extracted VST models using ducts to outside the building. As well as standard downflow cabinet models there is the ability to manufacture to user specifications. &squo;Downflow&squo; benches are sometimes called &squo;downdraft&squo;. All are used to remove obnoxious or toxic vapours as well as particulates. HOT AND COLD PLATES These innovative VarioTemp hotplates and coldplates use the latest Peltier technology controlled by a digital controller. The heating / cooling area is 200mm in diameter and controls within 0.5°C between +5°C and +70°C. The specialist model has a control range from -40°C to +150°C. All models have a super-quiet cooling fan. There are many laboratory applications for these hot and cold plate units as well as more specific applications in dentistry. Application notes are available on request. http://www.pharmaceutical-technology.com/projects/genentech/ Wed, 07 May 2008 00:00:00 GMT http://www.pharmaceutical-technology.com/projects/genentech/ Genentech Inc, Genentech Inc is one of the leading biotechnology corporations in the US, founded in 1976 with its HQ in San Francisco Bay in South San Francisco, California. The company is regarded by many as one of the pioneers of the biotech industry. Genentech now has facilities all around the world and employs more than 10,000 personnel. The majority shareholder of Genentech Inc is the Swiss pharmaceutical company Hoffmann La Roche. The company has many products in the commercial market in most spheres of treatment, including Activase/Cathflo, Nutropin, Pulmozyme, Rituxan, Herceptin, TNKase, Xolair, Raptiva, Avastin, Tarceva and Lucentis. Many of the products treat cancer, arthritis or asthma and others promote tissue growth and repair for patients suffering from heart, lung or other ailments. Genentech has the distinction as a company of being consistently voted by various business magazines as the best employer and most admired biotech company. It was named Top Employer by Science Magazine on 15 October 2007, where it has been recognised for the past six years. In October 2007 Genentech was also named the Most Admired Biotech Company. "Genentech now has facilities all around the world and employs more than 10,000 personnel." NEW FACILITY In 2006 Genentech obtained a new 75-acre site just 20 miles west of Portland in Hillsboro, Oregon. The intention was the construction of a new state-of-the-art $250m fill and finish facility, to occupy 25 acres, for the production of some of the newer drugs in the development pipeline. The facility broke ground in December 2006, completion of construction is expected in 2008 and the plant is expected to be in operation in 2010 following licensing and validation. There are expected to be 200‐250 employees initially at the plant and 300 employees by 2015. Construction of the facility will employ 960 full- and part-time workers, and across the Oregon economy will support 2,180 full- and part-time jobs. The fill and finish facility will also be partnered by a new west coast warehouse and distribution centre. The existing fill and finish facility is in California and is being relocated. The fill and finish facility will receive bulk frozen product shipped from other Genentech plants in California, at Vacaville and Oceanside, which will then be thawed, prepared with the addition of diluents or buffers, and filled into sterile vials or syringes before being packed and shipped. INCENTIVES The company received a number of incentives for building the plant in Oregon on a state and county level. Washington County waived millions in property taxes by negotiating a 15-year tax incentive agreement under the state's Strategic Investment Program. "The plant is expected to be in operation in 2010 following licensing and validation." Under this special deal, Genentech will pay the full property taxes on the first $25m of investment in land, building and equipment, but then anything up to a maximum of $250m will be exempt from taxation. Genentech also will pay an annual community service fee of $500,000, as well as an additional fee for each year of the 15-year agreement. The state of Oregon has also agreed to invest around $5m for worker training and infrastructure improvements. The Governor's Strategic Reserve Fund has provided $2m and this makes the total state investment in the project $4.8m. CONTRACTORS Group Mackenzie is providing site development services as part of the design build team for the new facility. Initially, Group Mackenzie prepared alternative conceptual site plans for the 12-acre Phase 1 project. Later in the project Group Mackenzie, in collaboration with Flad and Associates, prepared the final site plans and engineering plans and obtained approval from the city to build. Group Mackenzie provides civil engineering, landscape architecture design and construction documents for the project. http://www.pharmaceutical-technology.com/projects/pfizerdeutschland/ Wed, 30 Apr 2008 00:00:00 GMT http://www.pharmaceutical-technology.com/projects/pfizerdeutschland/ Pfizer, Newcon Containment Facility, Pfizer Manufacturing Deutschland GmbH is a large secondary manufacturing centre for Pfizer in Germany and has a reputation for efficiency, high containment and economy. The facility in Illertissen needed to increase its capacity in early 2006 to accommodate the growing market demand for the newly developed smoking cessation drug Chantix. The drug was first released to the commercial market in 2006 and Pfizer at Illertissen was the secondary production plant chosen to produce the drug from the highly potent API varenicline, which is produced in Ireland at the Little Island plant. The problem was there was a lack of capacity at the Illertissen plant for producing solid dosage forms under high containment, such as was required for Chantix. "The NEWCON facility was conceived, planned and constructed in a short timescale between 2006 and 2008." Because of this the NEWCON facility was conceived, planned and constructed in a short timescale between 2006 and 2008. In addition, Pfizer wanted to make the process more efficient by cutting the requirement for staff to use high containment suits during their day to day activities. PILOT SCALE Prior to the smoking cessation drug being brought to market, the Illertissen plant had already developed a pilot-scale high containment facility in 2003 inside the existing building, which was called ICON (Illertissen Containment). This facility demonstrated for the first time many of the new techniques, equipment and principles, which would be needed in the larger NEWCON facility. ICON introduced dust-free and fully automated production. The features of this system included: a single room concept with a hermetically sealed containment module; state-of-the-art isolator technologies; transport of hazardous substances by vacuum systems and split-valve containment technologies; and the use of laser-guided driverless vehicles, between weighing, granulation machines, tablet presses and coaters. NEWCON was designed on these principles. CONSTRUCTION The new containment facility for oral solid dosage started construction in 2006 and was designed by PhC Pharmaconsult of Heidelberg, who acted as architect and consultant for the project. The project and construction management were carried out by Pfizer itself using the experience of the team at Illertissen. The facility cost €35m ($55m) to construct and outfit and was completed six months ahead of schedule in October 2007. The new facility is 83,958ft² (7,800m²) in floor space and contains state-of-the-art containment technology. The concept of NEWCON uses a through-the-wall design where all production areas are screened off with a transparent containment screen; the driving machinery is located outside these areas for easy access for maintenance and repair. "The new facility is 83,958ft² (7,800m²) in floor space and contains state-of-the-art containment technology." The maximum workplace exposure to the API varenicline (dust/particle exposure) is set at 1‐10µg per m³ but the NEWCON facility is considerably within this, only allowing a maximum of 0.1µg per m³. The facility makes full use of process analytical technology (PAT) to carry out quality checks on the products. For example, near infrared (NIR) spectroscopy is used to confirm the homogeneity of batches and the presence of the active ingredient. The facility also uses the concept of lean manufacturing with three batches being processed simultaneously in different parts of the building. The three-shift system and semi-continuous production allows over a billion tablets to be produced every year. http://www.pharmaceutical-technology.com/projects/bms/ Wed, 23 Apr 2008 00:00:00 GMT http://www.pharmaceutical-technology.com/projects/bms/ Bristol Myers Squibb, Bristol-Myers Squibb (BMS) has been undergoing much the same rationalisation process as many large pharmaceutical companies have during the last couple of years. The pharmaceutical development business is changing and with these changes BMS has introduced a new strategy for the discovery of innovative medicines in areas of unmet medical need, in major areas such as Alzheimer's, diabetes, arthrosclerosis, hepatitis, AIDS/HIV, oncology and arthritis. In order to further develop its product pipeline and to develop collaboration and produce clinical supplies for trials, BMS has set up a new Center of Excellence at its New Brunswick, New Jersey facility in the US. "This expansion will form the basis of clinical supplies manufacture and drug product technology development." This expansion will form the basis of clinical supplies manufacture and drug product technology development. This will allow the company to produce the products required for trials and also to develop/investigate new production methods for its larger, continuous processing plants. INTEGRATION The project involved the expansion of an existing building to produce a new centre incorporating both early- (first-in-human) and late-phase clinical cGMP manufacture, as well as scale-up development. The new centre was also incorporated into the existing operations at the plant with little problem. Phase one of the project involved the expansion of the clinical supply operations (CSO) at the New Brunswick centre. The expanded CSO facility has several equipment innovations such as a full containment area for oral solid dose operations (OSD) and a flexible clinical-scale continuous barrier line. The facility can manufacture OSD clinical scale of up to 400kg and also fill liquid batches of up to 250l (multi-product and flexible facility). The first phase consolidated new mechanical space for processing, manufacturing and support. The second phase was able to add more processing space and a new product technology centre. The OSD batches produced in the CSO are around 10% of a commercial-scale batch. PHASE ONE The phase one expansion provided three new separated zones in the facility for 1) parenteral; 2) OSD band1‐4; and 3) OSD band 5. As part of the use of continuous process sterile isolators, the parenteral zone has an isolated vial filling line. "The PTC area can handle batch sizes from 20kg to 100kg for APIs in bands 1 to 4 categories." This has the following features: full nitrogen inert environment for safe use of solvents, full range of vial sizes filled, filling based on peristaltic or rotary piston pumps, automatic loading of lyophiliser and use of cold shelf, thermocouples for product monitoring, Class 100 conditions for capping, automatic differential pressure to contain highly potent compounds, automatic CIP (clean-in-place) for duct work and exterior vial washing prior to filling. The filling line is supplied from one of two formulation isolators with rapid transfer ports for aseptic transfer of materials, equipment and compounds. PHASE TWO The OSD band 1‐4 area was expanded in phase two and is to handle active pharmaceutical ingredients (APIs) in band 4 and below. This part of the facility has a long-term stability area which has processing rooms for handling solid dosage clinical materials (band 4) and an area for solvent coating of band 5 compounds. The OSD band 5 area has two processing suites, primary containment equipment comprising various isolator technologies. There is also closed system processing equipment, contained material transfer systems and isolated operation areas. Both of the OSD areas have wet and dry milling equipment, compression, encapsulation, dry milling and tumble blending equipment. PRODUCT TECHNOLOGY CENTRE The PTC area can handle batch sizes from 20kg to 100kg for APIs in bands 1 to 4 categories. There are a range of new technologies on offer, including holt melt extrusion, pelletising and nanomilling. Other functions include capsule filling, roller compaction, tablet compression, high shear wet processing, blending and tablet coating. There is also an in-process laboratory, yellow lighting for light-sensitive ingredients and low humidity. CONTRACTORS The engineering design was carried out by IPS Inc and the construction manager was Torcon Inc. The phase one expansion was 8,650m² and cost $54m (€34m). The second phase was 3,651m² and cost $37m (€24m).