Malvern Panalytical Drug Development Technologies

Characterisation technologies

Malvern Panalytical has a wide range of characterisation technologies that can be used to accelerate the drug development process. Its methods are used by scientists and engineers to maximise productivity and increase time-to-market.

Through a range of high-quality, customer-focused characterisation services, Malvern Panalytical delivers cost-effective chemical, physical and structural analysis of materials for the indication of performance in drug products.

Solutions range from tools that can run reliably and unattended, to systems that provide information on several key attributes in a single analysis such as particle size, shape, chemical identity, molecular weight, size, and concentration.

Analysis of materials for development and manufacturing of drugs

Malvern Panalytical’s instruments are deployed across the pharmaceutical industry for discovery, development and manufacturing applications. Whether developing new, ground-breaking drugs or generic formulations, both the time and cost associated with pharmaceutical development is significant. In addition, work-flow efficiencies may be achieved when these tools are used in conjunction with each other.

Malvern Panalytical is focused on providing well-designed, innovative analytical instruments, which follow the quality by design (QbD) ethos in the fields of drug discovery, chemical and formulation development, and pharmaceutical manufacturing.

The company understands what is involved in the development and manufacturing of a drug product and the requirements to measure the critical material attributes (CMA), as well as critical quality attributes (CQA) affecting the critical process parameters (CPP) in the manufacturing process.

Molecule discovery tools

High throughput screening of large libraries of chemical compounds is the dominant technique used in early stage drug discovery, with dynamic light scattering being the optimum tool.

Being able to measure very small particle size at low concentrations, it is ideally suited as a screening tool for identifying even small levels of aggregation and potential inhibition.

Molecule optimisation with laser diffraction

In order to monitor efficacy of the suspension accurately, administering trial drug candidates in this form requires accurate, repeatable and validatable control of the active ingredient’s particle size, often on limited sample volumes.

Laser diffraction is the best tool to meet these pre-formulation requirements. This technique provides particle size distribution of nano-scale material, while also having a wide dynamic range.

Chemical development for drug delivery

When characterising bioavailability or bioequivalence of nasally administered drugs, in support of new drug applications (NDAs) or abbreviated new drug applications (ANDAs), for nasal aerosols and sprays, the US Food and Drug Administration (FDA) recommends several tests.

In cases where the active component or components are suspensions, one important attribute is the drug particle size distribution. A laser diffraction system fit for this purpose must be able to rapidly measure obscuration (optical concentration), in addition to changes in droplet size distribution and span in real-time over the life of a single actuation from the drug delivery device.

Formulation development of drugs

The size of a liposomal vesicle plays a pivotal role in the pharmacokinetic and pharmacodynamics attributes of chemotherapeutic drugs, with the liposome acting as a carrier of the drug to the site of action and dynamic light scattering can be an effective technique.

Triple-detection size exclusion chromatography (TD-SEC) can accurately characterise polymer excipient molecular size and weight and avoid incorrect determination. The conditions of a tablet coating process can be simulated using a rotational rheometer system.

The viscosity of the liquid coating is measured initially under low stress conditions to quantify its full structure, then at high shear rates to simulate spraying, and again at low stress conditions to assess the viscosity rebuild with time.

Online particle analysis for drug manufacturing

Granulation can improve the ease of handling of powder blends and prevents the segregation of fine constituents, improving consistency in subsequent process steps, principally tableting.

To improve the efficiency of the milling operation, and deliver more consistent milled particle sizes, online particle-size analysis is a solution for continuous milling monitoring and control. In addition, measurements made by the online analyser can control the process through a closed loop with the mill’s programmable logic controller (PLC).

Founded in the late-1960s as Malvern Instruments, Malvern Panalytical is now one of the world’s leading materials and biophysical characterisation companies.

Having built on a long-established reputation for innovation in particle sizing, the company today is highly respected for its technology and applications leadership in areas that range from particle, protein and macromolecule characterisation through to rheological properties measurement and into process optimisation.

Malvern Panalytical understands that when a customer chooses to invest in a Malvern Panalytical product, that customer is making a serious financial commitment. The company takes this seriously, and strives to ensure that the customer is reminded that they will receive exceptional and personalised support for the many years they will have Malvern Panalytical equipment.

Please contact Malvern Panalytical with your business enquiry.

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Product and Services
White Papers

Calculating Pressure, Pipe Measurement, and Flow Rate Requirements for a Non-Newtonian Fluid

When pumping fluids over long distances, the required pressure, pipe diameter, and flow rate is calculated. For non-Newtonian fluids, it is sufficient to consider them as power law fluids, in terms of processing, due to the shear rates.

Malvern Panalytical Images

Products and Services

Insitec Range

Insitec systems provides continuous online analysis of particle size analysis, ensuring economical, efficient monitoring of industrial processes.

Kinexus Range

Kinexus is a next-generation rotational rheometer platform, developed according to industry feedback.

Mastersizer Range

The Mastersizer range comprises easy-to-use, accurate and reliable particle size analysers.

Morphologi G3

The Morphologi G3 is an easy-to-use, advanced particle characterization tool for measuring the size and shape of particles, with sizes ranging from 0.5µ to several millimeters.

OmniSEC Software

OmniSEC software is an integrated solution for advanced analysis of proteins and polymers by GPC/SEC, and is essential for Viscotek systems and detectors.

Viscosizer TD

Malvern Viscosizer TD is an automated biophysical characterization tool that uses Taylor dispersion analysis to provide ultra-low volume, solution-based molecular size and stability measurement capabilities.

Viscotek Range

The Viscotek range comprises of complete systems, software and detectors, which are all supported by Malvern's worldwide network to provide training and advice.

Viscotek UV Detector

The Viscotek UV detector is sold to complement the Viscotek TDAmax, which completes a tetra detector format.

Zetasizer AT for Dynamic Light Scattering

Malvern's Zetasizer AT brings the industry leading Dynamic Light Scattering (DLS) technology of the Zetasizer Nano to the process development and manufacturing arena, enabling real time monitoring of nanoscale particle processes online.

The Zetasizer Range

Malvern' Zetasizer series measures particle and molecule size from below a nanometer to several microns using dynamic light scattering, zeta potential and electrophoretic mobility.

White Papers

Calculating Pressure, Pipe Measurement, and Flow Rate Requirements for a Non-Newtonian Fluid

When pumping fluids over long distances, the required pressure, pipe diameter, and flow rate is calculated. For non-Newtonian fluids, it is sufficient to consider them as power law fluids, in terms of processing, due to the shear rates.

11 January 2018

Stability Characterisation Using Differential Scanning Calorimetry

An important parameter in production, manufacturing, formulation, and long-term storage, protein stability has large effects on biopharmaceutical products and higher stability means for greater profits and less product waste.

5 January 2018

Top Eight Reasons to Update Your DSC Analysis System

Differential Scanning Calorimetry (DSC) data is used to advance stable and developable proteins into the pipeline, while optimising process and formulation conditions to maintain stability between manufacture and storage.

15 December 2017

Introducing Morphologically Directed Raman Spectroscopy

Drug formulation, an integral step in the regulated pharmaceutical industry, involves the careful blending and processing of precisely specified and measured components to create a final product that can be administered to deliver the required clinical dose.

7 December 2017

Definition of Common Terms Used in Dynamic Light Scattering

The following list gives a definition of a number of terms, with notes on their specific use in the context of dynamic light scattering.

23 November 2017

Press Release

12 January 2018

Malvern is hosting a webinar to provide an overview of the nanoparticle characterization platform NanoSight NS300.

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11 December 2017

Detailed particle characterisation, including shape and size analysis and chemical identification, enables thorough understanding of drug formulations.

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4 December 2017

Malvern Panalytical has announced the launch of a collaborative project that aims to support the development of existing and next generation biopharmaceutical products.

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6 September 2017

Malvern will be hosting a wide range of webinars throughout September and October

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18 July 2017

Supplier of analytical X-ray instrumentation and software PANalytical has announced the introduction of a new Epsilon 1 X-ray fluorescence (XRF) spectrometer.

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11 July 2017

Understanding the make-up of crystalline structures is a vital aspect of the characterisation of new compounds, and can be regarded as an important first step towards the possibility of tailoring its properties.

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26 April 2017

A new webinar by Malvern evaluates and discusses size-exclusion chromatography (SEC) data to see the impact of different formulations on monoclonal antibodies and biosimilar molecules.

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6 April 2017

Malvern presents a webinar discussing the differences between rheometers and viscometers.

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7 March 2017

Malvern has announced two upcoming webinars this month: Differential scanning calorimetry (robust and powerful physical characterisation of therapeutic protein products) and Cement (composition, structure, and fineness - we are stronger together!).

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20 February 2017

Packing density and flow behaviour of metal powders has an effect on manufacturing efficiency of powder bed additives.

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17 February 2017

Malvern has announced it will be unveiling its new protein stability characterisation product for regulated environments MicroCal PEAQ-DSC in an upcoming webinar.

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14 February 2017

Malvern has announced that it will be presenting a webinar on the basic principles of particle size analysis.

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6 February 2017

Malvern has announced it will present a webinar discussing the particle tracking analysis (PTA) method (ISO19430) and what it means for nanoparticle measurements.

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1 February 2017

If you are attending Pittcon this year, why not register for Malvern's short courses, which are taught by recognised characterisation experts.

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23 January 2017

Malvern has announced it will be hosting a webinar about the use of laser diffraction as a technique in characterising nebulisers and how it is helpful in understanding the delivery of the drug product.

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17 January 2017

Malvern has announced it will host a webinar to discuss how to measure zeta surface potential.

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11 January 2017

Size exclusion chromatography (SEC) is a popular analytical technique for studying protein molecular weight, oligomeric state, aggregation, and conjugation.

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12 December 2016

Malvern has announced it will host a live-panel webinar for the discussion of challenges submitted in an online form on the company's website.

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5 December 2016

Malvern has announced it will be hosting a webinar discussing gel permeation chromatography (GPC), which is also known as size exclusion chromatography (SEC).

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24 November 2016

Malvern has announced its latest webinar discussing the types of technologies used for analysing particulates in injectable drugs.

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9 November 2016

Advancements in portable electronic devices such as mobile phones and laptops has increased demand for advances in battery technology.

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8 November 2016

Malvern has announced it will host a webinar discussing the use of a diffusion interaction parameter (kD) measurement for the Taylor dispersion analysis in early stages of development.

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3 November 2016

Malvern will be hosting a webinar to discuss the rheological requirements of paintings and coatings, as well as how they can be measured using a rotational rheometer.

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10 October 2016

Malvern has announced it will be hosting a webinar to showcase new measurer NanoSight NS3000, which uses Nanoparticle Tracking Analysis (NTA).

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8 September 2016

Cosmetics, paints, inks, paper, drug delivery, personal care, food or intra-lipid emulsions are made up of multi component chemistries.

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18 August 2016

The food and drug administration (FDA) has used Malvern's Morphologi G3-ID system to generate key data for the approval of the first generic nasal spray containing mometasone furoate.

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7 June 2016

Malvern Instruments has launched the new Zetasizer AT, a robust, online, automated analyzer that uses dynamic light scattering (DLS) to automatically measure the size of nanoparticles in suspensions and emulsions.

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7 March 2016

Malvern is proud to announce they will be hosting a webinar on 8 March at 10:30AM EDT.

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4 March 2016

Researchers working on the European Metrology Research Project NanoChOp (Chemical and Optical Characterisation of Nanomaterials in Biological Systems), funded by EURAMET, have concluded the NanoSight Nanoparticle Tracking Analysis system offers a unique insight into the behaviour of nanoparticles in biological systems.

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11 December 2015

Malvern has highlighted its ongoing commitment to extending and supporting the application of NanoSight, a nanoparticle characterisation technology with unique capabilities, by releasing new software and expanding the global technical specialist team.

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3 December 2015

Malvern Instruments and Bio-Rad from Hercules, California, are collaborating to deliver new analytical tools for the rapid identification of unknown particles.

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2 November 2015

Particle Characterization Laboratories director William Bernt has highlighted the impact of adding a Malvern NanoSight nanoparticle tracking analysis (NTA) system to the toolkit for nanoparticles.

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14 October 2015

New tools from Malvern that address specific analytical challenges in biopharma development will take centre stage at this year's AAPS Annual Meeting and Exposition, in Orlando, US.

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24 September 2015

Insight from CP Kelco, a global leader in the specialty hydrocolloids market, provides a blueprint for the intelligent, cost-efficient deployment of gel permeation/size exclusion chromatography (GPC/SEC) in biopolymer manufacture.

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19 September 2015

Malvern has opened a new biopharmaceutical applications laboratory in San Diego.

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18 September 2015

Malvern Instruments has launched an improved rSolution platform on their Kinexus rotational rheometer.

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29 May 2015

Researchers in the department of Chemical and Biomolecular Engineering at Ohio State University, Columbus, Ohio, US, are using Malvern's NanoSight nanoparticle tracking analysis (NTA) to study extracellular vesicle yields from different cell culture lines.

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28 January 2015

Malvern has launched a new gel permeation / size exclusion chromatography (GPC / SEC) platform, which delivers high performance and productivity for analytical laboratories.

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22 January 2015

Malvern Instruments will showcase a new chromatography system and detectors at Pittcon 2015 on 8-12 March in New Orleans, US.

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14 January 2015

A new whitepaper from Malvern Instruments on oral solid dose (OSD) deformulation demonstrates how the analytical technique of morphologically directed Raman spectroscopy (MDRS) can be used to accelerate development of generic products to a successful conclusion.

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7 January 2015

Malvern Instruments product development manager for Process Systems Alon Vaisman will speak about two different analytical techniques and their applications, as part of the particle characterisation session at the 2015 International Forum on Process Analytical Technology and Quality by Design (IFPAC) annual meeting.

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26 November 2014

Malvern Instruments has published a new application note examining the use of NanoSight Nanoparticle Tracking Analysis (NTA) technology in the study of extracellular vesicles.

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21 November 2014

'Extending the boundaries of QbD', a new whitepaper explores the application of Quality by Design (QbD) principles to the development of analytical instrumentation and its benefits.

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14 November 2014

Malvern Instruments has released new guidance on using automated image analysis to detect and quantify agglomerates.

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24 October 2014

Malvern Instruments is attending the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition at San Diego Convention Center in San Diego.

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17 October 2014

Malvern Instruments has released new 'third anniversary' accessories for the Mastersizer 3000, helping to reduce the time and cost of developing and validating robust methods for pharmaceutical particle size analysis.

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11 September 2014

The cross-disciplinary capabilities of Malvern Instruments' technology are being fully exploited at Queen Mary University in London, UK.

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21 August 2014

Malvern Instruments applications manager Dr Alan Rawle will give a plenary lecture at the Particulate Systems Analysis (PSA) 2014 conference and exhibition, organised by the Royal Society of Chemistry's Particle Characterisation Group.

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28 July 2014

Researchers at The School of Freshwater Science, University of Wisconsin-Milwaukee, US, are using NanoSight Nanoparticle Tracking Analysis (NTA) from Malvern Instruments to investigate the effects of nanoparticle contaminants on freshwater organisms.

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8 July 2014

The new Zetasizer Helix from Malvern Instruments enables the detailed study of mechanisms of protein aggregation and is a powerful tool for early stage biopharmaceutical development.

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8 June 2014

Malvern Instruments Ltd. (Malvern, UK) has announced that it has entered into an agreement with GE Healthcare Life Sciences to acquire the company's MicroCal microcalorimetry business.

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29 May 2014

Researchers within the the Departement Environnement et Agro-biotechnologies (EVA) of the Centre de Recherche Public - Gabriel Lippmann, Luxembourg, are using the nanoparticle tracking analysis (NTA) technique for the characterisation of nanoparticles within their toxicological studies.

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9 May 2014

The new Zetasizer NanoSampler from Malvern Instruments is a versatile, compact, fully automated sample delivery system for the Zetasizer Nano, the most widely used system for nanoparticle and colloid characterisation.

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15 April 2014

Malvern Instruments reports on the publication of the 1,000th peer-reviewed paper to cite the company's NanoSight Nanoparticle Tracking Analysis, NTA. Entitled 'Fumed Silica Nanoparticle Mediated Biomimicry for Optimal Cell-Material Interactions for Artificial Organ Development', it was authored by the research team of professor Alexander Seifalian from University College London.

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15 April 2014

Dr Alan Rawle, applications manager for Malvern Instruments, has been invited to speak as part of the Brian Scarlett Memorial Session at the 7th World Congress for Particle Technology (WCPT 7), which takes place in Beijing, China, from 19-22 May.

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29 September 2013

Malvern Instruments has acquired Wiltshire-based NanoSight Ltd, specialists in technology and instruments that are used worldwide to measure the size and other characteristics of nano-sized materials.

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