Clinical Trial Materials

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.

Catalent completes $4.6 million expansion at Singapore clinical supply facility and marks 20 years in the region.

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule technology, at its Edinburgh facility in Scotland.

The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.

The new suite will be used to produce non-sterile dosage forms, such as metered dose inhalers and semisolid topical products, for clinical studies up to Phase II.

The company will begin trials with its CBD chewing gum, CanChew Plus, for the treatment of irritable bowel syndrome.

Catalent plans a $4.6 million investment to expand secondary packaging and storage in Asia.

Catalent’s Singapore facility is awarded GMP certification.

Geographic location, customs and drug-development regulations knowledge, and transportation infrastructure were factors in Catalent Pharma Solutions' selection of Shanghai for its clinical-trials supply facility.

ISPE's survey is industry's first large-scale effort to collect data on patient experiences with clinical trial materials.

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

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.

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

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

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.

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

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.

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

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.

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."

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

The outsourcing of clinical-trial materials grows as pharmaceutical companies adapt to a changing market.

The authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.

This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.