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.

Lonza's 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, both platform approaches and tailored solutions are employed where appropriate, enabling the inclusion of adaptable development strategies into DNA-to-IND programs. Embracing this philosophy achieves accelerated paths to IND, ensuring products reach the clinic faster.

This webinar shares Lonza's integrated drug substance and drug product CMC strategy, along with technical case studies from process and analytical development that provide insight into delivering tailored product-specific solutions.

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