Biologics CMC PIP

Challenge: A therapeutics company in a Phase III clinical trial required a skilled CMC/Quality specialist to oversee Contract Manufacturing Organization (CMO) operations. The client needed expertise in cGMP upstream and downstream drug substance manufacturing processes for a monoclonal antibody, as well as support for process characterization studies and Biologics License Application (BLA) preparedness.

Solution: Viltis promptly deployed a highly qualified local consultant to provide onsite support in Saint Louis, MO. The consultant brought extensive expertise in cGMP manufacturing and quality oversight, ensuring effective collaboration with the CMO. Viltis’ tailored solution addressed the client’s immediate needs by integrating seamlessly into their operations and delivering targeted support.

Results: With the assistance of the Viltis consultant, the client achieved robust oversight of cGMP production and successfully conducted process characterization studies. The consultant also played a critical role in advancing BLA preparedness activities, ensuring the client met stringent regulatory requirements and maintained clinical trial timelines.

Impact: Viltis’ specialized support enabled the client to maintain operational excellence during a critical phase of their monoclonal antibody development. By ensuring compliance, enhancing process control, and expediting regulatory preparedness, Viltis contributed to the client’s progress toward bringing a life-changing therapeutic to market.