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 ...
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% ...
HanchorBio and WuXi Biologics collaborate to develop fusion proteins using the Fc-Based Designer Biologics platform, ...
"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 ...
Biologics manufacturers urged to develop a chemistry, manufacturing, and controls (CMC) management strategy for reference material early.
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 ...
Y-Biologics said on the 7th that it signed a contract manufacturing and development (CDMO) deal with China's WuXi Biologics to develop new drugs using its next-generation triple-target immuno-oncology ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results