Drug Development

Articles

Endotoxin removal from a finished product is a major challenge for biopharmaceutical manufacturers; particularly as all endotoxin removal methods have operational limitations and may result in loss of protein.

Removing endotoxin from biopharmaceutical solutions

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Select contract manufacturing organizations roll out expansions for production of active pharmaceutical ingredients and intermediates.

Tracking CMO Activity

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

Inside IPEC–Americas: Evaluating Excipient Stability

H. Leonhard Ohrem is Technical Manager at Merck KGaA (Germany).

Roberto Ognibene is Technical Support, Merck KGaA (Germany).

Parteck ODT is a newly introduced ready-to-use excipient for fast melt tablets.

Is another ODT excipient necessary?

Biologics enhance their positions amidst slowing growth in the global and US markets.

Shifting Fortunes in API Market Growth

The author of a book about biopharmaceutical production includes irrelevant information.

More Than You Need to Know about Manufacturing Pharmaceutical Proteins

The US Pharmacopeia is revising its monographs for four pharmaceutical excipients: propylene glycol, sorbitol solution, sorbitol sorbitan solution, and noncrystalllizing sorbitol solution.

USP Seeks Comments on Four Excipient Monographs

Formulators and manufacturers have many options for modifying release profiles in multiple-API products.

Down the Track: Different Speeds with Multiple APIs

Michelle Hoffman, editorial director of Pharmaceutical Technology.

A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.

The Biopharmaceutical Manufacturing Survey

High-potency manufacturing of active pharmaceutical ingredients is a growing and specialized capability.

APIs and Excipients