Biological Development Solutions

Biological products are increasingly being used in the prevention, diagnosis and treatment of a growing range of health conditions. Biopharmaceutical research and development is expanding rapidly within both academic and industrial settings. Subjects range from peptides and recombinant proteins, enzymes, monoclonal antibodies (mAbs), antibody drug conjugates (ADCs), bispecific antibodies and nucleic acids to viral vaccines, gene therapy vectors and cell therapies. Many of our biological solutions address areas of unmet clinical need where there is increased pressure to bring drugs to market.

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.