Pharmaceutical manufacturing is the industrial-scale process of producing medications through chemical synthesis, biotechnology, or extraction, ensuring both quality and regulatory compliance.
How to build flexibility into your CGT manufacturing process while maintaining regulatory compliance
MasterControl research shows 40% of advanced therapy executives aren't confident they can meet CGT demand over the next three ...
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using ...
The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products ...
Francer is Lilly’s vice president, head of global regulatory policy and strategy. Cruz is Lilly’s senior vice president, ...
SAN FRANCISCO--(BUSINESS WIRE)--Multiply Labs, a robotics company developing industry-leading automated manufacturing systems to produce individualized drugs, and GenScript Biotech Corporation ...
This two-story, 78,000-sq-ft pharmaceutical manufacturing facility located at a prominent corner of Genentech's 200-acre headquarters campus was designed to produce innovative drugs. As the prototype ...
“Integrating PAT enables right-first-time production, as real-time data and predictive models minimize errors and ensure ...
Trinity Biotech has received earlier than expected approval from the World Health Organization (WHO) to permit the later-stage manufacturing process of TrinScreen HIV and Uni-Gold HIV at its ...
VILNIUS, LT / ACCESS Newswire / July 15, 2025 / AATec Medical GmbH ("AATec"), a biotech company developing a multi-product platform for the treatment of respiratory diseases, and Northway Biotech ...
Leveraging Northway Biotech's 20+ years of CDMO expertise, Kaida BioPharma is advancing KAD101, a targeted therapy for hormone-driven ovarian cancer Under the terms of the agreement, Northway Biotech ...
VILNIUS, LT / ACCESS Newswire / July 29, 2025 / Diorasis Therapeutics (“DTx”), a preclinical-stage biotechnology company developing gene therapies for ophthalmic diseases, has entered into a strategic ...
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