Drug Development

Articles

The state of oral solid dose manufacturing is influenced by new approaches, novel technologies, and the structural evolution of the raw materials market.

Examining Trends in Oral Solid Dosage Manufacturing

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program. 

Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

Roquette Launches Next-Generation Direct Compression Solutions

Greg Paddon-Jones, PhD, is director of Product Development at Antares Health Products.

The author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.

Emerging Applications of Vitamin E TPGS in Drug Delivery

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

CBER maps modernization plan to handle surge in research and applications. 

FDA Expands Oversight of Cell and Gene Therapies

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

Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing. 

Electrochemistry for API Synthesis

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

Biologic Standards in the Pharmacopoeias: An Update

Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.

Roquette Acquires Indian Excipient Manufacturer

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality. 

Industry Perspectives on Quality–A Conversation with Pfizer CentreOne

Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.

APIs and Excipients