Tailored CMC Solutions To Overcome The Challenges In Fabs And Fc-Fusion Development Programs

As the development of more complex molecular formats, with increasingly intricate product quality attributes, gains momentum, characterizing them and developing robust manufacturing processes becomes paramount. This webinar discusses the unique challenges of Fabs and Fc-fusion protein process development and manufacture and highlights innovative solutions to achieve an accelerated path to IND.

Our approach focuses on using a tailored program design enabled by identifying the common hurdles faced in Fabs and Fc-fusion development. Rather than using a one-size-fits all solution, we employ both platform approaches and tailored solutions where appropriate, enabling the inclusion of adaptable development strategies into DNA-to-IND programs. By embracing this philosophy, we achieve accelerated paths to IND, ensuring products reach the clinic faster.

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.

You Will Learn:

• Some of the most pressing challenges in the process and analytical development of novel molecular biologic formats, particularly Fabs and Fc-fusion proteins
• How some of these key challenges can be addressed with example case studies
• Lonza's end-to-end integrated drug substance and drug product CMC strategy to accelerate the path of a complex molecule to IND