LFB Biomanufacturing
Monica Bejarano is a highly experienced project leader in CMC regulatory affairs with a focus on biologics and plasma-derived products, currently working at LFB Biomédicaments since October 2021. Responsibilities include coordinating responses to EMA CMC questions and overseeing technical reviews of regulatory documents for product registration in various international markets. Previous roles include project manager in international pharmaceutical affairs at BIOGARAN, where significant accomplishments included increasing sales through successful product registrations in West and Central Africa, and regulatory affairs CMC manager at DBV Technologies, focusing on immunology and combination products. Monica Bejarano's educational background includes advanced degrees in pharmacy, regulatory affairs, and business administration from prestigious institutions such as the London School of Economics, Université Paris-Saclay, and Universidad Nacional de Colombia.
LFB Biomanufacturing
LFB Biomanufacturing is an expert CDMO in the development and manufacture of recombinant proteins via cell culture, with specific know-how in the area of monoclonal antibodies (mAbs). LFB Biomanufacturing supplies a full range of bioproduction services, from the development of cell lines to the manufacturing clinical and commercial batches of active substances from biological products up to multiple pool of 2000L Cell Culture production capacities using Disposable Bioreactors Technology and exclusively Single-Use systems. The Alès site is regulary inspected by Customers as well as Health Agencies, including French-ANSM and US-FDA. LFB Biomanufacturing is subsidiary of the LFB Group.