Tailored CMC Solutions That Meet the Needs of Novel Molecular Biologic Formats

Antibodies still predominate in the clinic, however there is a large shift in drug development pipelines to more complex, next generation biologics. This presents product-specific requirements, for which platform approaches are not always an appropriate approach.

Lonza Biologics has decades of experience in developing and manufacturing novel molecular formats and other recombinant proteins, comprising approximately 40% of the large molecules our teams supported in 2021. 

In this webinar, we share our integrated drug substance and drug product CMC strategy, along with 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.

Key Learning Objectives:

• What are the product-specific requirements around developing more complex, next-generation biologics?
• How can these challenges not only be resolved, but the timeline to clinic even be accelerated?
• Technical case studies to demonstrate these challenges and solutions in both process and analytical development