Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Biocatalysis, chemocatalysis, and other chiral technologies continue to attract the investment dollars of CMOs and fine-chemical companies.

Building Toolboxes in Pursuit of Single-Enantiomer Drugs

David Edwards is Director of Pharmaceutical Technology at Capsugel.

Direct dosing APIs during R&D studies can reduce the overall testing time of a drug candidate by allowing for a greater throughput of compounds through the R&D department.

Improving R&D with API microdosing

The increasing cost of crucial manufacturing input factors, such as energy and raw materials, has been a severe threat to several companies.

API Market Challenges

Excipients are the hidden champions of drug development-no API works consistently without the right excipient. Pharmaceutical excipients, however, require stringent quality management. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.

A Supplier's Role in Ensuring and Improving Excipient Quality

As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.

Building Technology Positions in API Manufacturing

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

The Determination and Control of Genotoxic Impurities in APIs

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

API Purification

The authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.

Controlled Release from Porous Platforms

O-arylation and O-alkylation, a one-pot protein synthesis, a combined approach in continued and chemocatalysis, and green-chemistry applications are the target of some recent advances in API synthesis.

Improving API Synthesis

The solid form of an API plays a crucial role in drug quality, and advancing methods for screening, detection, and characterization is key.

APIs and Excipients