Drug Development

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

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.

Designing a Biomanufacturing Facility Incorporating Single-Use Technologies

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

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.

Polymorph Screening for Identification of Relevant Crystalline Forms

Scale-down modeling accelerates the development of downstream biopharma manufacturing processes.

Small-Scale Modeling Boosts Downstream Development

Analytical laboratory equipment adapts for new realities of downsizing, outsourcing, and speed demands.

APIs and Excipients