Accelerating A Complex Molecule From Cell Line Development To cGMP In 12 Months

Moving complex novel biologics from discovery to clinical trial material in under a year requires a fundamentally different approach than traditional mAb development. For a challenging bispecific fusion protein, success was achieved by de-risking an aggressive 12-month schedule through strategic process design.

Key to compressing this timeline was implementing parallel development, initiating process work using stable pools at month four while cell line optimization was still underway. Furthermore, the molecule’s extreme pH sensitivity and risk of product variants demanded a non-standard downstream purification strategy. This involved leveraging high-throughput screening to design a custom mixed-mode resin workflow that protected the monomer and ensured a robust, scalable, and regulatory-quality product.

Learn the specific technical and strategic decisions behind overcoming complex expression barriers and rapidly advancing novel modalities to the clinic.