Novel Molecular Biologic Formats Require Tailored CMC Solutions

New molecular formats and other recombinant proteins present facility- and product-specific development requirements that often render platform approaches inappropriate. Accordingly, addressing the most pressing challenges in process and analytical development associated with novel molecular biologic formats requires a keen understanding of the applicable tools and strategies.

Recently, Andrew Brown, a Support Manager for Global Process Development at Lonza Biologics, presented a webinar sharing Lonza’s integrated drug substance and drug product CMC strategy. He also explored technical case studies from process and analytical development that provide insight into how we have delivered tailored, product-specific solutions and enabled the acceleration of novel molecular formats into the clinic.