Overcoming biological development challenges
The complexity of biological molecules and the technical and economic challenges surrounding their successful development as therapeutic entities are well-documented. Developers of both innovator products and biosimilars are faced with the need to improve their selection and biological development processes and to reduce cycle times, while also containing costs. Early biological characterization of potential drug substances to ease the selection of developable candidates, together with the application of reliable biophysical characterization techniques throughout the development cycle, is critical to their success.
Experience in biophysical analysis
Malvern Panalytical has extensive experience in biological developments, working closely with industry experts as the characterization needs in biopharmaceutical development and production have continued to evolve. We provide biophysical characterization technologies that provide the insight required to understand and optimize the critical quality attributes (CQAs) associated with defining and optimizing a biological product’s quality and performance. These analytical tools help ensure data integrity and validation from fundamental research through to product manufacturing, all supported by applications knowledge and expertise that is specific to biopharmaceutical industry requirements.