Malvern Instruments Biopharmaceutical and Drug Development

Characterisation technologies

Malvern offers characterisation tools for molecular analysis and small drug discovery to help accelerate development for the pharmaceutical industry.

Systems for critical material attribute information

Malvern has a wide range of experience in small molecule pharmaceuticals.

Services include systems that provide information on variables identified as critical material attributes (CMA) such as particle size, shape and chemical identity, or molecular weight and size.

Whether characterising particle size and morphological properties of a novel active pharmaceutical ingredient (API) or rheological attributes of a new chemical entity (NCE), Malvern can achieve efficiency using common platform technologies.

Small molecule drug discovery and development

Malvern’s range of analytical solutions focuses on testing and manufacturing requirements, while taking into account time and cost pressures, as well as sample availability and complexity.

Label-free technologies appeal to researchers across various applications, including biological research, biotherapeutic and small molecule drug discovery and development, immunogenicity studies, vaccine development and quality control.

Label-free techniques are used in the direct study of native molecules, and generate biologically relevant data enabling understanding of molecular interactions without using artificial probes or labels.

Isothermal titration calorimetry for biomolecular interactions

Malvern’s MicroCal range includes isothermal titration calorimetry (ITC) and differential scanning calorimetry (DSC).

ITC is used in quantitative studies of a range of biomolecular interactions, that work by directly measuring heat that is either released or absorbed during a biomolecular binding event.

By providing a complete thermodynamic profile of the molecular interaction, ITC can explain mechanisms’ underlying interactions, and enable more confident decision-making in hit selection and lead optimisation.

DSC is used to characterise stability of a protein or other biomolecules directly in its native form, and achieves this by measuring heat change associated with the molecule’s thermal denaturation.

Precise and high-quality data obtained from DSC provides vital information on protein stability in process development, and in the formulation of potential therapeutic candidates.

Size exclusion chromatography systems for assessment of product purity

Malvern’s analytical toolbox for biopharmaceutical development is tailored to provide trusted solutions such as OMNISEC size exclusion chromatography systems to assess product purity.

The Zetasizer range is also available for sizing and zeta potential analysis for product stability.

The company’s Archimedes and NanoSight systems quantify early aggregation in bioformulations.

About Malvern

Malvern’s technical experts are available to support and work with researchers to find the right solution for individual challenges.

Providing agile technology development in partnership with its Bioscience Development Initiative, Malvern is always looking for new solutions to enable quicker, easier and more useful analysis.

The company has a suite of instruments that provides access to biophysical information focused on accelerating through characterisation studies, formulation development and quality control.

Malvern provides high-quality products and helps clients to achieve maximum return from investment.

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Press Release

The new Zetasizer AT – Automated Online Nanoparticle Sizing for Process Monitoring

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.

Product and Services
White Papers

Stability Analysis of Proteins for the Biopharmaceutical Industry

The biggest class of biopharmaceuticals on the market is monoclonal antibodies (mAb) and their specific binding nature provides an opportunity to use them to modulate pharmaceutically-relevant molecule activity to control or prevent disease.

Address
Malvern Instruments

Enigma Business Park

Grovewood Road

Malvern

WR14 1XZ

Worcestershire

United Kingdom

+44 1684 892 456 +44 1684 892 789 www.malvern.com www.pharmaceutical-technology.com/contractors/lab_equip/malvern_instruments Malvern Store

Malvern Instruments Images

White Papers

Dynamic Light Scattering – Common Terms Defined

There are a number of sources of information that give a mathematical description of the terms used in light scattering. However, these will not usually give assistance in understanding their practical application.

12 October 2017

Gold Nanoparticle Applications and Characterisation by Nanoparticle Tracking Analysis

Gold nanoparticles are one of the most popular and extensively researched type of nanoparticle.

9 August 2017

An Analysis of Polymer Branching Using GPC / SEC Methodology

Polymer branching has been proven to have a potentially considerable impact on many physical properties of synthesised polymers, such as the disruption of crystallinity and a possible increase in single chain density and chain entanglements.

2 July 2017

Reasons to Replace Your Viscometer with a Rheometer

It may be time to assess what a modern rheometer can do, especially in comparison to a viscometer.

22 September 2017

An Analysis of Antibodies Using Multi-Detector SEC Methodology

Antibodies' innate ability to direct their neutralisation attacks toward specific components in harmful agents has generated a large amount of interest within the pharmaceutical industry.

13 July 2017

Stability Analysis of Proteins for the Biopharmaceutical Industry

The biggest class of biopharmaceuticals on the market is monoclonal antibodies (mAb) and their specific binding nature provides an opportunity to use them to modulate pharmaceutically-relevant molecule activity to control or prevent disease.

7 September 2017

Press Release

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

Malvern has announced it will be hosting a new webinar presenting size-exclusion chromatography (SEC) data and discussing the impact of different formulations and external stress conditions on Monoclonal antibodies and biosimilar molecules.

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6 April 2017

Malvern has announced it will host a new webinar discussing the difference between rheometers and viscometer to help viewers decide which of the two is most suitable for their application.

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7 March 2017

Malvern is hosting two 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

Efficiency of the production process of powder bed additives is reliant on packing density and flow behaviour of metal powders involved.

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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, you can 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 presenting a webinar discussing 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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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
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 demonstrating the NanoSight NS3000, which uses Nanoparticle Tracking Analysis (NTA) to measure nanoparticles and concentrates.

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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. Most products go through a stage where different phases co-exist such as emulsions, suspensions or dispersions and as such require a specific amount of stability in order to meet expected performance criteria.

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18 August 2016

Key data for the approval of a nasal spray containing mometasone furoate has been obtained by the Food and Drug Administration (FDA) through the use of Malvern's Morphologi G3-ID system.

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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 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

The latest software release and expansion of the global technical specialist team highlight Malvern Instruments' ongoing commitment to extending and supporting the application of NanoSight, a nanoparticle characterisation technology with unique capabilities.

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3 December 2015

A collaboration between Malvern Instruments and Bio-Rad from Hercules, California has delivered new analytical tools for the rapid identification of unknown particles.

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2 November 2015

Insights shared by Particle Characterization Laboratories director William Bernt highlights 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 be at the AAPS Annual Meeting and Exposition 2015, 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 established a new biopharmaceutical applications laboratory in the heart of San Diego's biotechnology cluster.

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18 September 2015

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

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Regional Offices

Malvern Instruments

Enigma Business Park

Grovewood Road

Malvern

WR14 1XZ

Worcestershire

United Kingdom

+44 1684 892 456 +44 1684 892 789 www.malvern.com www.pharmaceutical-technology.com/contractors/lab_equip/malvern_instruments Malvern Store
Malvern Canada

4995 Levy Street

Montreal

H4R 2N9

Quebec

Canada

+1 800 932 0101 +1 508 768 6403
Malvern Instruments China

Unit 101, XinAn Plaza

Building 13

No 99 Tianzhou Road

200233

Shanghai

China

+86 21 6113 3777 +86 4006 306 902 +86 4008 206 902 +86 8008 206 902 +86 21 6113 3778
Malvern Instruments Nordic

Korskildelund 6

DK-2670 Greve

Zealand

Denmark

+45 369 151 00 +45 369 151 01
Malvern Instruments Nordic

Kumitehtaankatu 5

Klondyke

Kerava

FIN-04260

Helsinki

Finland

+ 358 968 995 231 +358 968 995 232
Malvern Instruments SA

Parc Club de l'Université

30 Rue Jean Rostand

Orsay Cedex

91893

Ile-de-France

France

+33 169 351 800 +33 160 191 326 www.malvern.com/fr
Malvern Instruments GmbH

Marie-Curie-Str. 4/1

71083 Herrenberg

Germany

+49 703 297 770 +49 703 277 854 www.malvern.de
Malvern Aimil Instruments Pvt Ltd BSEL Tech Park

11th floor Sector - 30A Opp Vashi Railway Station

Vashi

Navi Mumbai

400 705

Mumbai

India

+91 22 3964 6600 +91 22 3964 6666
North Bldg 511 Kobe International Business Center

5-5-2 Minatojimaminami-machi Chuo-ku

Kobe-shi

Hyogo Prefecture

650-0047

Honshu

Japan

+81 78 306 3806 +81 78 306 3807 www.malvern.jp
Malvern Instruments Korea 7F SH Energy B/D

16-6 Sunae-Dong

Bundang-Gu, Seongnam-City

Kyeonggi-Do

Seoul

South Korea

+82 31 786 0840 +82 31 786 0950 www.malvern.co.kr
Malvern Instruments

Av. De La Industria No 300

San Pedro Garza Garcia

CP 66279

Nuevo Leon

Mexico

+52 5556 846 548
Malvern Instruments Nordic AB

Vallongatan 1

Uppsala

752 28

Uppsala County

Sweden

+46 185 52 455 +46 185 51 114
Malvern Instruments Inc

117 Flanders Road

Westborough

MA

01581-1042

Maine

United States of America

+1 508 768 6400 +1 508 768 6403

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