SAN DIEGO—With plans to advance 10 drugs into the clinic over the next five years for a variety of disorders, Entos Pharmaceuticals didn’t want to depend on contract manufacturers for the drug ...

Life science companies must adhere to the FDA’s Good Manufacturing Practices (GMP) in manufacturing and storage of the product within their manufacturing facility. For example, GMP compliance is ...

Teknova, which produces life science reagents, opened its newest GMP-certified production facility which, the company claims, will enable bioprocessing and gene therapy companies to get into the ...

The study makes clear that regulators expect human oversight to remain central to pharmaceutical quality assurance. Human operators must participate at key control points and retain authority to ...

— Partnership Combines Sequence Design Expertise with End-to-End GMP Manufacturing to Streamline mRNA Development and Scale-up — CHARLOTTETOWN, Prince Edward Island & WORCESTER, Mass., November 06, ...

State-of-the-art 21,500 square foot facility integrates research, development, manufacturing, and testing for end-to-end autologous CAR T-cell therapy production Dosing of first patient in Phase 1/2 ...

As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of ...

As the year draws to a close, medium and small drugmakers in India have a deadline coming up in less than two months as the country moves to secure the production of safe and quality medicines. After ...

Advanced technologies in pharma manufacturing necessitate a redefinition of the Qualified Person's role, focusing on digital ...

BIOVECTRA, a part of Agilent Technologies Inc., and Revolution Biomanufacturing Inc. today announced a collaboration that grants BIOVECTRA access to Revolution Biomanufacturing's proprietary platforms ...

— Partnership Combines Sequence Design Expertise with End-to-End GMP Manufacturing to Streamline mRNA Development and Scale-up — BIOVECTRA, a part of Agilent Technologies Inc., and Revolution ...