Drug Development

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

Articles

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.

Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations

New catalysts show promise for pharmaceutical intermediate and API synthesis.

Cost-Effective Catalysts Could Replace Traditional Multi-Step Processes

FDA redefines cocrystals as APIs and not drug-product intermediates.

“Rebirth” of Cocrystals?

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.

Recipharm Adds New Lab to Italian API Facility

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.

Oxford Genetics Secures GBP1 Million Investment for Gene Therapy Technologies

Ashland opened a new pharmaceutical excipient manufacturing facility in Nanjing, China.

APIs and Excipients