Biopharmaceutical and Drug Development
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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.
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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Available White Papers
Using Mophologically Directed Raman Spectroscopy to Detect Counterfeit Drugs In drug formulation, precise components require careful blending and processing to create a final product that can be administered to deliver the required clinical dose.
Develop Stable Dispersions in Formulation Development with Zetasizer Formulation development is a critical activity for many industries, from pharmaceuticals, to paints and coatings. Stability is a crucial element, making a direct impact on performance, shelf-life. Kerb appeal, and worth.
What to Keep in Mind when Purchasing an Advanced Gel Permeation Chromatography (GPC)/Size Exclusion Chromatography (SEC) System Buying a new piece of laboratory equipment is always a big decision, with thousands of dollars often being invested on relatively little information.
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.
Using Differential Scanning Calorimetry in Lipid Bilayer Membranes to Characterise Thermotropic Phase Transitions Proteins and other constituents are bound or incorporated into cell membrane surface bilayers formed by lipids.