Drug Development

Articles

Kollicoat MAE 100-55 from BASF can be used as a direct substitute in commercial enteric pharmaceutical formulations.

BASF Extends Kollicoat Excipient Line

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

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

Conjugation Chemistry with Highly Potent Compounds

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

A global API marketplace increases the burden of supply chain monitoring for drug companies.

More Outsourcing? More Monitoring.

Agnes Shanley is senior editor of Pharmaceutical Technology.

Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf

U.S. Representatives Question the Safety of the Heparin Supply

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

Novo Nordisk Builds Manufacturing Facility in North Carolina

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

CMC Biologics and IDT Biologika Collaborate on ADC Manufacturing

Thermo Scientific TruTools chemometrics package extends the capabilities of the portable TruScan RM Raman Analyzer.

Chemometrics Software Expands Use of Raman Analyzer

David J. Skanchy, PhD, is a review chemist with the US Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, tel. 240.276.8552, fax 240.276.8582.

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances

Stephen Hoag, a professor at the University of Maryland (Baltimore), and a member of the National Institute of Pharmaceutical Technology and Education (NIPTE) offers a brief update on issues, and NIPTE’s database project.

Unifying Excipient Databases

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

APIs and Excipients