Breaking News on Global Pharmaceutical Technology & Manufacturing

Contract manufacturing news in brief

By Kirsty Barnes, 23-Aug-2007

Related topics: Regulatory & Safety

Patheon, Lifeline Cell Technology and SRI International have all recently announced new contract manufacturing deals of late.

UK firm Phoqus has hired Canadian firm Patheon's UK division to undertake part of the tablet manufacturing process for its drug Chronocort, for planned Phase III trials

 

 

 

Chronocort is being developed as a once-daily modified release hydrocortisone tablet for the treatment of adrenal insufficiency, a condition which causes Addison's disease, hypopituitarism and congenital adrenal hyperplasia.

 

 

 

Phoqus is hoping to launch the drug in the fourth quarter of 2009, where it will enter a market worth in excess of £75 million, (€63 million) worldwide.

 

 

 

However, although Patheon's Swindon (UK) operations offer full commercial manufacturing services for conventional solid and semi-solid dosage forms, sterile products and high-potency products, it seems, that Patheon may not necessarily be in the frame to conduct the commercial manufacturing of Chronocort - Phoqus said that "it has started the process of identifying and selecting a contract manufacturing partner for the future commercial manufacture of the drug".

 

 

In other news this week, California's International Stem Cell Corporation has announced that its subsidiary, Lifeline Cell Technology, has entered into an agreement to manufacture adipose (fat)-derived stem cell research products for Cytori Therapeutics.

 

 

 

Under the deal, Lifeline will process and derive stem cells from adipose tissue provided by Cytori, with the objective to yield batches of frozen vials of stem cells that have been isolated, purified and expanded from the adipose tissue.

 

 

 

These standardised human stem cells will then move into Cytori's international supply chain, where they will be used for research purposes for studies into regenerative medicine and basic cell biology, said the firm.

 

 

 

Meanwhile, SRI International has received a $4.6m contract from the National Institute of Allergy and Infectious Diseases (NIAID) in the US, to research, develop and manufacture improved dosage formulations of new and existing HIV or AIDS-related anti-infectives and microbicides.

 

 

 

Under the arrangement, SRI will also provide the NIAID with analytical chemistry evaluation of drug substances intended for pharmacology studies and clinical trials. The evaluations will help ensure that materials used in drug studies conform to US Food and Drug Administration (FDA) regulations and are of a defined quality, said the firm.

 

 

 

SRI is a not-for-profit CRO, and a major provider of preclinical and clinical services to US government agencies such as the National Institutes of Health (of which NIAID is a part of), along with biopharma firms.

 

 

 

The multifunctional contract research organisation (CRO) already manages the largest government program for the development of anti-infectives. Last month it was also part of a consort of firms that received parts of a total contract worth over $13m by the US Defense Advanced Research Projects Agency (DARPA), to jointly accelerate emergency protein and vaccine manufacturing capabilities against a range of biological threats, in order to enhance the US' ability to rapidly and cost effectively respond in the event of a biological attack.

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