Monoclonal antibodies for all: A new method of biotherapeutics production in transgenic goat milk

Joint Event on 18^th European Biosimilars Congress Joint Event on 35^th Annual European Pharma Congress

April 14-15, 2025 Webinar

Francois Xavier Frapaise

Bio-sourcing, Belgium

Keynote: J Bioanal Biomed

Abstract :

The issue of access to life-saving biologics is a pressing global concern, particularly affecting low- and middle-income countries. High costs associated with branded biologics create substantial financial challenges for healthcare systems, with countries like China and Brazil seeing significantly lower treatment rates for critical conditions such as breast and colorectal cancer compared to the United States. Despite advancements in healthcare, access remains limited, especially in Africa, where even charitable efforts struggle to improve the situation. The disparity highlights the urgent need for solutions that increase the availability of these essential therapies. The manufacturing processes for biologics contribute significantly to their cost and accessibility challenges. Biologics are produced using complex bio manufacturing techniques, often requiring substantial capital investment in facilities and technology. Current methods, such as using CHO cells, face regulatory and operational constraints that limit the reduction of production costs. Additionally, the biosimilar market encounters hurdles in development and approval, which can delay the introduction of more affordable options. As manufacturers grapple with high costs and regulatory pressures, the profitability of biosimilars is further squeezed by significant discounts offered by reference products. Innovative approaches, such as using genetically engineered goat milk, present a promising avenue for producing affordable therapeutic proteins. The advancement of genome editing technologies like CRISPR/ Cas9 allows for the efficient creation of transgenic livestock capable of yielding high quantities of biologically active proteins. While regulatory concerns surrounding animal-derived products persist, the potential of this biotechnological approach could significantly improve access to life-saving treatments. Ongoing discussions with health authorities in regions lacking access to biologics suggest a pathway forward, emphasizing the ethical imperative to bridge the gap in global healthcare access.

Biography :

Francois Xavier Frapaise, MD, has over 40 years of international drug development, strategic planning and marketing experience at major pharmaceutical companies, including: Sanofi, Bayer and Abbott, and has held multiple C-level positions (CSO, CMO, CEO) in different Pharmacos in the US and Europe. He is currently heading a Clinical/Regulatory Consulting Company. Xavier has extensive experience in biosimilars development (Merck KGaA, Boehringer- Ingelheim, Pfenex) and more recently at Bio-Sourcing (Liege, Belgium). He held an academic position at the Thrombosis Research Center at the Loyola Medical Center in Maywood (IL). He holds an MD degree from Faculté de Médecine René Descartes, Paris France, and is an INSEAD alumni.