Drug Development

Articles

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

AGC Asahi Glass Acquires CMC Biologics

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

Oxford Genetics Receives Grant from Innovate UK

Saneca Pharma has received a EUR1.5 million grant from the Slovak Ministry of Education, Science, Research, and Sport, which will be used to drive forward new R&D initiatives for API manufacturing.

Saneca Invests in API Manufacturing R&D

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.

New Opportunities for Cocrystals

Non-precious-metal catalysts are increasingly employed for commercial API synthesis.

New Horizons for Cross-Coupling Reactions

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Patheon Acquires Roche API Site

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

Oxford Genetics and University of Oxford Form Virus Production Pact

David W. Osborne, PhD, is Chief Scientific Officer and Founder, Independent Derm Solutions, LLC, 4215 Creekside Court, Fort Collins, CO 80525.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

APIs and Excipients