Drug Development

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.


The CDMO Evolution

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.

Niche APIs By Popular Demand

J. Scott Mellors is principal scientist at 908 Devices Inc.

Helen Yan is senior associate scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320.

Burton Lee is senior associate scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Jiemin Bao is scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Tawnya Flick is principal scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Laura E. Blue is principal scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320.

The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API. 

Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS Method

Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.

Accepting the Challenge of Protein Characterization

Wayland Rushing, PhD, is director, scientific affairs for Eurofins, BioPharma Product Testing.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Designing Phase-Appropriate CMC Analytical Programs

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Pharmaceutical Technology spoke with Anil Kane, executive director, global science and technology, pharmaceutical development services, at Thermo Fisher Scientific about the industry’s need for more capacity in the manufacture of highly potent APIs.

Ensuring Manufacturing of HPAPIs Under Safe Conditions

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

HPAPI Capacity Challenges

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

Bringing Gene Therapies to Market

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

Gene Therapy Production Must Pass Regulatory Hurdles

An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.

APIs and Excipients