Novartis Pharma AG, Switzerland – susanne.joerg@novartis.com

Special aspects in the pharmaceutical development of protein formats beyond mAbs

In the past decades, monoclonal antibodies have become the fastest growing area of biopharmaceutical industry. Currently, alternative protein formats – such as FAbs, scFvs, nanobodies, etc – are under development. These new antibody and therapeutic protein formats come along with new challenges in the pharmaceutical development, i.e. in the formulation and manufacturing process development of biopharmaceutical drug products.

To meet the quality target product profile of those products, a variety of critical quality parameters need to be addressed during development studies. Special attention is paid towards control of formation of soluble aggregates and particulate matter during manufacturing and storage of the finished drug product. The viscosity of the formulated drug product is in a suitable range allowing convenient administration of the desired dosage. Furthermore, compatibility of the protein with disposable materials used during preparation and administration to the patient needs to be assured.

In this presentation, case studies from the pharmaceutical development of drug products of different protein formats are presented.

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