The chemistry, manufacturing and controls (CMC) path to a successful investigational new drug (IND) submission and biologics license application (BLA) for therapeutic biologics is both an exercise in strategy deployment and a race against the clock. Drug developers and consultants that facilitate their path to regulatory filing must execute robust CMC development strategies while simultaneously assembling documentation that will hold up to the scrutiny of jurisdictional regulatory authorities.
As most CMC consultants are fully aware, consultants and service providers alike should jointly operate in the client’s best interest. Rarely, the three-way relationship between the contract development and manufacturing organization (CDMO), the client organization is as complementary as it should be.
CMC consultants play a critical role in successfully advancing lifesaving biologics medicines and guiding biologics programs through critical milestones. Therefore, an optimal biologics program outcome requires a CDMO that is purposefully built to work effectively and in concert with clients and CMC consultants.
In this webinar, the expert panel will discuss key considerations for CDMO selection to ensure a seamless integration of service provider and consultant, including process and data transparency, facility design and person-in-plant accommodations. They will also discuss how the Portable CMC® platform provides a focused, streamlined approach to CMC development and clinical manufacturing through modular work packages, structured documentation support and flexible workflows that align priorities in favor of client success.
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Register for this webinar today to gain critical insights into optimizing CMC development for biologics programs and ensuring successful IND and BLA submissions.
Keywords: Antibodies, Drug Development, Biologics, CRO, Investigational New Drug, Regulatory, Contract Manufacturing, CMC, Commercial Manufacturing, CDMO, CDMO/CMO