Biotechnology firm Acorda Therapeutics and contract manufacturer CMC Icos Biologics have entered an agreement whereby the latter will produce GGF2, the lead molecule in Acorda's neuregulin program.

In preclinical studies, neuregulins have demonstrated potential for neurological protection in a number of indications, including models of multiple sclerosis (MS) and stroke, the firm said.

From its recently acquired facilities in Seattle, CMC Icos will be responsible for the process development, manufacturing scale-up and current good manufacturing practices (cGMP) manufacturing of GGF2.

Acorda said it will use the supply of GGF2 for continued toxicology studies and early phase clinical trials, the results of which it plans to use to file an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for GGF2 in late 2009.

"Scaling up and validating the manufacturing process of this compound is an important step toward advancing GGF2 from the lab to the clinic," said Andrew Blight, chief scientific officer of Acorda.

"We chose to work with CMC ICOS because of their extensive expertise in cell culture and analytical methods in biologics manufacturing."

Meanwhile, Obecure, a clinical stage company focused on drug development for weight management, has executed a manufacturing and supply agreement with Farmaceutici Formenti SPA, the Italian Subsidiary of the Grunenthal Group.

Obecure is currently investigating the use of Histalean - an established drug, comprised of betahistine and approved in Europe for the treatment of vertigo - for the new indications of obesity and drug-related weight gain and is currently preparing to conduct additional dose ranging clinical studies for both indications.

Farmaceutici Formenti SPA is a leading manufacturer of generic betahistine, sold in Europe under the name Microser.

According to the terms of the agreement, the Italian firm will supply Obecure with betahistine and matching placebo tablets for use in its upcoming clinical studies.

Obecure said that pending successful development and receipt of a marketing authorisation of Histalean in Europe for the new indications, Farmaceutici Formenti SPA will exclusively supply the betahistine tablets for packaging the drug for sale in Europe and will also be entitled to license Histalean for co-marketing in Italy.

"This agreement is a major step forward in the development of Histalean for Obesity and weight management and to ensure its availability to patients upon approval," said Dr Yaffa Beck, CEO of Obecure.

"The Grunenthal Group is a leader in the European pharmaceutical industry and provides Obecure access to large scale production and marketing organisation and the capacity to meet production and quality goals."

Recently, non-profit biopharmaceutical contract manufacturer Florida Biologix, announced that it has now expanded its total fill and finish (including post-fill processing, labelling, inspection and packaging) capacity by 50 per cent.

The new, dedicated, multi-product module is validated and compliant with cGMP standards and has an ISO 6 fill suite in which fills occur in ISO 5 vertical laminar flow stations, the company said.

New equipment has also been installed including a Flexseal 10 semi-automatic crimping machine, a Sartocheck 4 Integrity Tester, and repeat pipettors.

"The new space and equipment are important for us to better fulfill client needs for our formulation and aseptic cGMP fills," said company director of operations Linna Lim.

In other related news, Chinese vaccines company Bio-Bridge Science has entered into a non-binding memorandum of understanding with US firm JR Scientific - a manufacturer of classical and custom cell culture medium and sera products - along with the company's president and CEO Jan Baker, to form a joint venture.

The joint venture is being formed in order to produce culture medium, serum, and other biomaterial that is used in vaccine production as well as scientific research, for sale in China and other countries.

Under the proposed arrangement, JR Scientific will transfer technology and 'know-how' to the joint venture, which is earmarked for a total investment of $1.4m.

Dr Liang Qiao, chairman and CEO of Bio-Bridge said, "The joint venture will fit into our strategic plan by providing a potential source of revenue as well as vaccine material for our own vaccine research and production."