Whether developing innovative new drug products or racing to be the first-to-file a complex generic product, the time, cost and risk associated with pharmaceutical drug product development is significant. Malvern Panalytical provides the physicochemical analysis tools and expertise to help mitigate these challenges, helping our customers speed products through the development workflow by supporting critical assessments of drug product attributes and behavior.
Malvern Panalytical’s solutions add value throughout the pharmaceutical development cycle, from drug discovery and preformulation through to scale-up and manufacturing. We help our customers gain the physicochemical insight required to understand and ultimately control the critical material attributes (CMAs) and critical process parameters (CPPs) associated with defining and optimizing drug product performance.
Our technologies confirm the identity, activity, molecular conformation, morphological properties, solid form and stability of Active Pharmaceutical Ingredients (APIs) and excipients. We can then generate understanding of how these impact on and interact within a drug product formulation by characterizing formulation properties such as dispersion stability and rheology, providing insights into the behavior of specific components within a formulation during manufacturing and storage. Our solutions scale with the changing requirements of different stages in the development pipeline, ensuring workflow efficiencies are achieved throughout development and manufacture.
Malvern Panalytical’s strength is not only in the breadth of our complementary physicochemical characterization tools, but also in our applications understanding and experience. This enables us to provide the most relevant physicochemical measurement approaches, and also partner with our customers in effectively applying these solutions to accelerate product development and optimize product quality.
We understand the challenges associated with the deployment of analytical systems within highly regulated environments, and ensure that you are supported with the appropriate software and documentation to facilitate rapid method development, validation and transfer. This helps save time and money - not only in bringing a new drug product to market, but also in maintaining its performance throughout its lifecycle.