The formulation balancing act: overcoming composition and manufacturing challenges

The final formulation step in monoclonal antibody (mAbs) manufacturing – while established – holds critical challenges with efforts continuing to enhance efficacy, safety, and cost-efficiency. This is especially true for self-injectable mAbs, which must be formulated at a high concentration to avoid pain and pressure at the injection site.

This article discusses the latest research in excipients and buffer composition in reducing viscosity and aggregation, as well as preventing degradation, to develop a stable and patient-friendly commercial mAb. It also addresses key manufacturing considerations, like single-use technologies, in minimizing risks and improving efficiency. Both are essential to address the complexities of high-concentration formulations, and ultimately delivering high-quality, life-saving therapies to patients worldwide.

This article is published in European Pharmaceutical Manufacturing, May/June 2024, Vol. 24, Issue 3.

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Author:

Dr. Nandu Deorkar

Senior Vice President, Research & Development – Biopharma Production, Avantor

Nandu Deorkar is Senior Vice President, Biopharma Production Research & Development for Avantor. He is responsible for innovation strategy and planning, and execution of new products and technology development. During his more than 25-year career in research & development, Dr. Deorkar has been leading teams working on various aspects of upstream and downstream bioprocessing, single use systems, chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer. He has published more than 30 articles and holds more than 20 patents. Dr. Deorkar received Ph.D. from Indian Institute of Technology, Mumbai, India and MBA in Marketing from Fairleigh Dickinson University, Madison, NJ, USA.