Manufacturing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

To further enhance its position in clinical-trial materials supply, Catalent Pharma Solutions has agreed to acquire the clinical-trial supplies business of Aptuit for $410 million on a cash and debt-fee basis.

Catalent to Acquire Aptuit's Clinical-Trial Supply Business

With a new North American headquarters and expanded operations, Almac is furthering its transatlantic approach to contract development and manufacturing.

Almac Expands in North America

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

FDA's final rule on clinical trials

As emerging markets become increasingly important for the pharmaceutical majors, companies are re-evaluating their outsourcing strategies. This article is part of the 2010 Outsourcing Resources special issue.

Contract R&D and Clinical Materials Outsourcing in Emerging Markets

From product development to finished patient kits, Rockwell Automation equipment is used throughout the entire process.

Global Pharmaceutical company implements clinical trial management solution

The author examines the use and advantages of disposable technologies in the fill–finish of sterile pharmaceutical products and how these technologies can reduce costs and time in producing clinical-trial materials.

Disposable Technologies for Fill-Finish of Clinical-Trial Materials

CROs and CMOs expand to gain a piece of the market for clinical trial materials.

Outsourcing Clinical Trial Materials

Sylvia Findlay is Pharmaceuticals and Biotechnology Industry Analyst at Frost & Sullivan.

The CRO market is experiencing two-tiered growth: firstly from pharmaceutical companies seeking to lower fixed costs by outsourcing clinical research to CROs; and secondly, from biotechnology and specialty pharmaceutical companies that lack the infrastructure to conduct trials.

Outsourcing clinical trials: growth continues

On March 3, the US Food and Drug Administration released a draft guidance for Industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format."

Draft Guidance Issued for Drug and Biologics Labeling

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report.

CMC service providers are doing well, but clinical and preclinical CROs are doing even better.