Drug Development

Articles

This article provides an overview of functionality, functionality-related characteristics, and excipients performance.

Functionality and Performance of Excipients

Facing cost pressures and regulatory changes, pharmaceutical companies address the need for increased functionality by looking to excipients.

Current Trends and Challenges in the Excipients Market

The Product Quality Research Institute (PQRI) conducted an open, publicly available, electronic survey of current excipient-control strategies among pharmaceutical excipient manufacturers, excipient distributors, and drug-product manufacturers (excipient users). Among the major findings are:

PQRI Survey of Pharmaceutical Excipient Testing and Control Strategies Used by Excipient Manufacturers, Excipient Distributors, and Drug-Product Manufacturers

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Potent-compound awareness training for operators is important to understand why the containment and controls are in place. 

Contract Manufacturing Organizations Expand in High-Potency Manufacturing

The debate over functionality is not about to be settled anytime soon. 

Debating Excipient Functionality

Combinatorial catalysis in asymmetric synthesis and asymmetric biaryl Suzuki coupling highlight recent advances in chiral chemistry. Plus the marriage of green and chiral chemistry.

Rolling Out Advances in Chiral Chemistry

Select large custom manufacturers expand capacity, private equity firms buy companies in transition, and players from India and China build their positions. 

Rising Players in Global Fine Chemicals

CMOs account for 20–30% of biopharm production. Big Pharma also is filling the biologics supply chain. 

A Capacity Wave in Biologics Manufacturing

Indian suppliers of active pharmaceutical ingredients and dosage formulations expand in India, the United States, and Europe. 

Asian Producers Raise Their Profiles In the Global Pharmaceutical Value Chain

New biocatalytic and chemocatalytic routes to chiral intermediates and developments in simulated-moving-bed and supercritical-fluid chromatography for resolving racemic mixtures. 

APIs and Excipients