the Office of Biotechnology Products (OBP) is currently in the process of implementing 'quality by design' (QbD). QbD requires a thorough understanding of a product and its process of manufacture ...

Seven leading biotech industry players have teamed up to create a fictitious monoclonal antibody (mAb) that will serve as a quality-by-design example for the industry. The newly formed consortium ...

CHICAGO, February 26, 2025--(BUSINESS WIRE)--MAIA Biotechnology ... today announced the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC).