This paper describes the approach and benefits of using DPT Labs' QbD Scale Up service and follows the third paper in our Thought Leadership Series, 'QbD-Based Process Development Services: The DPT Labs Approach'.
DPT and Confab are part of Renaissance Acquisition Holdings’ portfolio of companies. Together DPT, and Confab offer a broader range of services with complementary manufacturing capabilities, expertise in product development, technical transfers and scale-up. We provide the ability to manufacture a wide range of products across multiple dosage forms and world-wide distribution.
DPT is a contract development and manufacturing organization (CDMO) that specializes in semi-solids and liquids. DPT offers unmatched technical expertise and fully integrated drug development and manufacturing services for sterile and non-sterile dosage forms.
From Non-Serile to Sterile,
From Concept to Commercialization,
From Virtual to Large Pharma.
Confab, a DPT Company, is a fully integrated CDMO. Our key focus and expertise is in the development and manufacturing of complex solid dose, semi-solid creams and suppositories and liquid products.
Partnering with DPT and Confab provides a seamless transition from pre-formulation and formulation development through to clinical supplies and commercial supply. Together, we are known in the industry for providing dependable high quality services to customers worldwide and for sharing success and growth with our partners and employees.
DPT provides comprehensive pharmaceutical research and development services focused on non-sterile and sterile semi-solid and liquid dosage forms.
Confab provides comprehensive pharmaceutical research and development services focused on immediate and sustained release solid, semi-solid, and liquid dosage forms.
Together, DPT and Confab offer complimentary manufacturing capabilities with expertise in product development, technical transfers and scale-up. Our scientists combine decades of pharmaceutical formulation development expertise with leading-edge technologies to provide the best solutions to our customers’ needs.
Pharmaceutical research and development services
Our pharmaceutical research and development services include:
- Formulation development
- Analytical development
- Analytical validation
- Drug packaging services
- Process development
- Stability studies
- Clinical trial materials
- Regulatory submission support
- Inhalation product testing
Non-sterile and sterile pharmaceutical research and development expertise
Our expertise in research and development non-sterile and sterile items include:
- Liquid FFS
- Plastic ampoules
- Aerosol formulations
- Nasal sprays
Semi-solids and liquids
DPT’s Center of Excellence for Semi-solids and Liquids is supported by in-house quality and microbiology labs, robust quality systems and a team of highly skilled technicians to support your manufacturing needs.
Semi-solid and liquid pharmaceutical manufacturing services
Our services for manufacturing of semi-solid and liquid pharmaceutical products include:
- Pilot, clinical trial material and commercial-scale manufacturing
- cGMP batch sizes from 0.3kg to 25,000kg
- Compartmentalized, controlled environment and XP compounding
- Controlled substances schedule II – V
- Extensive range of vessel, dissolver and mixing options
- Vacuum pressure capabilities
- Nitrogen / inert gas blanketing
- Direct-to-line packaging
- HEPA air filtration and improved air handling
- Wide range of lighting options for light-sensitive materials
- Semi-solid and liquid packaging capabilities
- Advanced barrier systems
- Airless and metered-dose pump system
- Metal and laminate tubes
- Piston barrier systems
- Rectal and vaginal applicators
- Syringes: large format and dial dose
- Thermo and cold-form blisters for liquids and semi-solids
- Unique and specialized pharmaceutical packaging
- Virtually any secondary packaging required
Aseptic manufacturing services
Aseptic manufacturing services include:
- Aseptic processing and filling suites for small volume parenterals, ophthalmic preparations, nasal sprays and ointments
- Pilot, clinical trial material and commercial-scale manufacturing
- Comprehensive microbiology testing
- cGMP batch sizes from <500ml to 50l
- Controlled substances Schedule II – V
- Packaging capabilities for sterile dosage forms
- Micro-dose vials
- Unit-dose and bi-dose nasal sprays
At Confab, we combine infrastructure with teams of scientists who have an in-depth understanding of solids, semi-solids and liquids that is backed by decades of experience. It is this combination of people and infrastructure that sets us apart from other CDMOs.
Our main goal and market activities are in Canada and the United States. However, we also serve customers that market their products in South America, Europe and several Asian countries.
Confab offers a wide variety of manufacturing capabilities, including core centered tableting, tablet dry coating, granulation, tablets and hard shell capsules, several types of coating, creams, gels, ointments, nasal sprays, syrups, suspensions, liquids and suppositories.
Solid dose manufacturing capabilities
Our solid dose manufacturing capabilities include:
- Powder blending
- Standard granulation
- High shear granulation
- Powder compaction
- Tablet coating
- Double encapsulation
- Tablet printing
With the increased globalisation and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve.
Pharmaceutical drug product development can be an expensive and time-consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug product by regulatory agencies.
Samsung BioLogics opened its third biologics manufacturing plant in Songdo, South Korea, in October 2018. The plant made Samsung Group one of the world’s largest biologics contract manufacturing operators (CMO) in the world.
On 22 September, WuXi Biologics completed the first phase of development for a new perfusion biologics production plant in Wuxi City in China.
DPT Laboratories is attending the 2014 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition at San Diego Convention Center, US.
DPT Laboratories is to host a booth at the forthcoming INTERPHEX (International Pharmaceutical Expo).
Pharmaceutical contract development and manufacturing organizations (CDMOs) DPT Laboratories and Confab today announced the integration of the organizations under the leadership of Paul Johnson, group president and COO.
DPT Laboratories announced today that it has added two new members to its sales team.
DPT Laboratories received notification from the US Food and Drug Administration (FDA) on 19 February 2013 that signalled the completion of the its evaluation of DPT's corrective actions taken at its Lakewood, NJ, facility in response to the warning letter received on 27 August 2012.
Renaissance Acquisition Holdings, a portfolio company of RoundTable Healthcare Partners, announced today that it has acquired DPT Laboratories.
DPT Laboratories has announced today that Jeanette Riedle has been named senior director of continuous improvement.
DPT Laboratories has announced today that Kuljit S Bhatia has been named vice-president of research and development.
R&D manager of formulation and process development at DPT Laboratories, Michael Lowenborg, will be featured in a webcast on 7 December, offering insights from leading pharmaceutical industry experts on 'Optimizing Topical Drug Formulations and Manufacturing'.
DPT Laboratories today announced continued investments in its manufacturing facilities that further cement its position as the industry leader for semi-solids and liquids.
DPT Laboratories welcomed more than 20 students from the American Association of Pharmaceutical Scientists student chapter at the University of Texas College of Pharmacy Pharmaceutics Department to tour its San Antonio facilities on March 25.