APIs and Excipients

Catalent and MGC Pharma Partner for Production of Cell Lines

January 20, 2015

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

USP Elemental Impurities Implementation Set for January 2018

January 15, 2015

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Innovative Excipients in Solid-Dosage Manufacturing

January 02, 2015

API Custom Manufacturing Outlook: More Growth in 2015

January 02, 2015

Changing dynamics of the pharmaceutical industry are driving demand.

Chinese API and Drug Manufacturer Issued Warning Letter

December 31, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Protein Sciences Considers Sourcing Flublok From Japan

December 23, 2014

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

FDA Approves Novel Treatments in 2014

December 02, 2014

FDA approves treatments for new diseases and drugs that operate by new mechanisms.

Rapid Screening for Elemental Impurities using ICP-MS

November 15, 2014

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

Advances in Analytical Technology

November 15, 2014

Recent technology introductions demonstrate that accuracy, efficiency, and usability are top of mind for pharmaceutical industry professionals for analytical instruments.

Advances in Large-Scale Heterocyclic Synthesis

November 02, 2014

New practical approaches to the synthesis of complex heterocycles are reviewed.