Opportunities lie in enhancing regulatory compliance for biological drugs through specialized training. Courses focusing on CMC requirements, CTD quality modules, and molecule-specific strategies can ...

HanchorBio and WuXi Biologics collaborate to develop fusion proteins using the Fc-Based Designer Biologics platform, targeting oncology and autoimmune diseases. WuXi Biologics offers end-to-end ...

Discussion to Cover the Importance of Early-Stage CMC Testing in Enhancing Biologic Predictability, Scaling Up, and Accelerating Time to Market KAISERAUGST, Switzerland, April 22, 2025 /PRNewswire/ -- ...

Enhancements enable pharma, biotech and generics companies to streamline regulatory tracking and optimize life cycle management for small molecules and biologics CMC activities account for nearly 18% ...

"Regulatory flexibility must be tailored for cell and gene therapies," said FDA Commissioner Marty Makary, M.D., M.P.H. "These are common-sense reforms that will address the unique characteristics of ...

At a conference early next year, biologics manufacturers will be encouraged to develop a chemistry, manufacturing, and controls (CMC) management strategy for their reference material early in ...

Recognized as Biologics CDMO of the Year, BioDlink shares insights into the world's first approved EGFR-targeted ADC for recurrent/metastatic nasopharyngeal carcinoma The company enables seamless ...

DUBLIN--(BUSINESS WIRE)--The "Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products Training Course (Apr 23rd - Apr 24th, 2026)" training has been added to ...