Drug Development

Arthur J. Falk, PhD, is president and CDO of International Pharmaceutical Excipient Auditing (IPEA).

Articles

Securing the integrity of the excipient supply chain is a crucial task in ensuring the overall pharmaceutical supply chain. The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.

Excipient-Control Strategies

The potent nature of HPAPIs means there must be careful evaluation of the compound for its level of toxicity when considering manufacture.

Let's talk the same language

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Carbon–hydrogen functionalization, ketone α-alkylation, and biocatalysis are some recent advances in asymmetric synthesis.

Achieving Enantioselectivity

Near-infrared spectroscopy (NIR) is suitable for the analysis of pharmaceutical samples in various solid forms, and can be used for determining chemical properties (e.g., content of drug, water), as well as physical properties (e.g., particle size, tablet hardness).

Pseudo-polymorphic conversion by near-infrared spectroscopy

Sheryl Henderson is the director of Plant Network Strategy Implementation at Pfizer Inc.

Steven McWethy is the senior manager of the fermentation plant at Pfizer's Kalamazoo, Michigan, site.

Keith Dixon is the director of bioprocess development at Pfizer.

The authors describe the critical aspects of an ideal fermentation services provider.

Manufacturing Considerations for Sourcing GMP Fermentation Services

CMOs expand capacity and capabilities in high-potency manufacturing to meet strong demand for cytotoxic and other potent drugs.

CMOs Invest in High-Potency Manufacturing

Pharmaceutical companies developing new drug candidates for Hepatitis C virus infection now can test their compounds with a novel culture system that mimics the biology of HCV infection in humans.

New Culture System Models Human HCV Infection

Michelle Hoffman, editorial director of Pharmaceutical Technology.

Drugmakers seeking to block the activity of a protein may have a new strategy at their disposal.

Coming Down the Pike: Protein-Substrate Binding

A roundtable with John Doney, Jiao Yang, Hans Baer, and Elena Draganoiu.

Excipients in Polymeric Drug Delivery and Formulations

Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.

APIs and Excipients