Drug Development

David Edwards is Director of Pharmaceutical Technology at Capsugel.

Articles

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

Elham Blouet is Pharmaceutical Project & Development Manager, Pharmaceuticals & Cosmetics BU, at Roquette.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

Carbohydrates For Injection

The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.

FDA's New Process Validation Guidance: Industry Reaction, Questions, and Challenges

Dr. Andreas Stolle is head of business line pharma at Saltigo GmbH.

The increased trend of outsourcing coupled with a relatively strong economy has seen the fine chemicals market grow at a very high level when compared to historical data.

The Fine Chemicals Market

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

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

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

A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.

Achieving Containment in High-Potency Manufacturing: A Case Study for Solid Dosage Manufacturing

Tom Gelineau is Director, Business Development, at SAFC.

The market for HPAPIs is growing rapidly with the research industry's emphasis on oncology.

HPAPIs And Bioconjugates

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

Ingredients