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

The agency outlined the adjustments it's willing to make to "remove barriers and perceived misconceptions" for innovative medicines.

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 ...

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 ...

Arm yourself with the tools to write or assemble CMC sections of regulatory submission, to prepare for CMC meetings with FDA, and to avoid non-compliance.

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 ...

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.

A century-plus of steam-generated power production has shown the importance of water and steam chemistry. Just one boiler tube failure in a conventional unit or heat recovery steam generator (HRSG) ...

Flow Chemistry revolutionizes chemical synthesis, enhancing safety and efficiency in pharmaceuticals and sustainable manufacturing through continuous processes.