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 ...

New FDA communication introduces a more flexible, risk‑based chemistry, manufacturing, and controls (CMC) framework for cell and gene therapies, including phased data submission to support earlier ...

Citius Pharmaceuticals Inc. appointed drug industry veteran Kelly Creighton as executive vice president of chemistry, manufacturing and controls, the company announced Nov. 5. Creighton will be ...

In January 2020, the Food and Drug Administration (FDA) issued a guidance entitled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications ...

The quality of a drug product is determined by the manufacturing line. Preclinical assessments and clinical trials provide an indication of safety and efficacy, but it is the manufacturing process ...

SAN DIEGO--(BUSINESS WIRE)--Janux Therapeutics, a biopharmaceutical company developing novel T cell engager immunotherapies, today announced the appointment of Charles Winter as Senior Vice President ...

Chemistry engineered for real-world solutions. The I&EC Division brings together the full spectrum of industrial chemistry and engineering to solve today’s most pressing technological challenges.

Techne, bioMerieux, Roche, Lonza Group, Miltenyi Biotec India and More Cell and Gene Therapy Manufacturing QC Market Cell and ...

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 ...