Drug Development

Articles

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

Hovione Expands Drug Substance Manufacturing

Winners from the seven categories will be announced live at the event in Madrid.

CPhI Worldwide Reveals Pharma Awards Finalists

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

Process Improves the Bioavailability of Active Ingredients

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

EMD Millipore Provides Risk-Assessment Information for Raw Materials

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

FDA Cites India API Facility For CGMP Violations

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

Abenza Acquires US CDMO PacificGMP

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

Aragen Bioscience Licenses Protein Production Technology

Lisa has a PharmD. ad M.P.H, and is a consumer safety officer at FDA. She can be reached at Lisa.Tung@fda.hhs.org.

Maria Eng is a behavioral epidemiologist and adjunct professor at Johns Hopkins University. She has a Phar.D. and M.P.H. degrees.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

Lessons Learned from FDA Inspections of Foreign API Facilities

Agnes Shanley is senior editor of Pharmaceutical Technology.

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

APIs and Excipients