CMC Solutions to Meet the Product-Specific 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, which present product specific requirements, for which platform approaches are not always an appropriate approach. Lonza Biologics have 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 whitepaper, we will 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.