Accelerating mAb Development To Meet mAb Market Demand

By Scott J. Jacobia, Ph.D., Director, Cell Biology Bioprocess Production, Thermo Fisher Scientific and Sonjoy Mukerjee, Ph.D., Senior Staff Scientist, Field Applications Bioprocess Production , Thermo Fisher Scientific

Achieving market acceptance for new monoclonal antibodies (mAbs) can be limited by inefficiencies in their development and manufacturing processes. Common challenges that manufacturers face include insufficient titer, raw material issues, and problematic protein quality. To overcome these challenges, it is important to partner with a global supplier that has commercially available products to support high titer, can ensure supply assurance, and offers customer services to support custom media development and analytical analyses.

A partner with scale-up expertise and experience is a critical part of the commercialization process for any therapeutic. When selecting an ideal scale-up partner that can help successfully shepherd a biologic to the commercial market, it is important to evaluate their expertise and experience across a range of metrics. This includes process characterization, advanced analytics, product development, process optimization, tech transfer, biotech business modeling, risk mitigation strategies, timeline management, media manufacturing support, cGMP sourcing strategies, and process simplification. Additionally, many of the challenges associated with mAb scale-up can be overcome by solutions rooted in digitalization. By reducing the complexity involved in scale-up, tech transfer, and data management, companies can reap compounding benefits for their manufacturing processes.

With innovative products and services, advanced analytics, experienced teams, and worldwide redundancy, Thermo Fisher can serve as an ideal collaborator throughout the mAb manufacturing process. With its large manufacturing footprint and strategically located facilities, Thermo Fisher has the flexibility to minimize delays and maximize the quality of clients’ outcomes. This presence, coupled with its world-class logistics and distribution solutions, allow Thermo Fisher to streamline supply chains and help ensure just-in-time delivery.