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 ...
Techne, bioMerieux, Roche, Lonza Group, Miltenyi Biotec India and More Cell and Gene Therapy Manufacturing QC Market Cell and ...
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 ...
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 ...
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 ...
NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of ...
Flow Chemistry revolutionizes chemical synthesis, enhancing safety and efficiency in pharmaceuticals and sustainable manufacturing through continuous processes.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results