Contract manufacturing news in brief

By Gareth Macdonald

- Last updated on GMT

Related tags Pharmacology

CMC ICOS, PharmEng, HollisterStier and RxElite are among the contract manufacturing organisations (CMOs) with news updates over the last few days.

CMC ICOS refits biotech plant​ A biotechnology plant once operated by ICOS has been remodelled by its new Danish owners CMC ICOS Biologics who say they also plan to expand the staff. The 15,000-square-foot facility has been refurbished and given a new infrastructure that will accommodate the commercial manufacture of drugs for the biotech field under the practices required by government agencies, according to company president Gustavo Mahler. The multimillion-dollar expansion adds space for another 35 workers. This is the first manufacturing facility for CMC, which also has offices in Seattle and New England. The plan is to develop the Bothell facility into one of the largest contract manufacturers on the West Coast. PharmEng unit OK to make natural health products​ PharmEng International says that its subsidiary Keata Pharma has received a site license issued by the Canadian Ministry of Health under the authority of the Natural Health Products Regulations for manufacturing, packaging and labeling of natural health products at its facility located in Sydney, Nova Scotia. The 46,400 sq. ft. Sydney facility includes pilot laboratories for formulation development, rooms with various capabilities such as high shear mixing, container blending and equipment for modified release technology. The facility provides formulation development and testing services to manufacture and package products in solid and liquid dosage forms. The plant is also expected to receive its Precursor License under the Controlled Drugs and Substances Act which will allow the site to broaden the portfolio of controlled substances that it currently produces. HollisterStier gets UK GMP accreditation​ HollisterStier Contract Manufacturing has received a certificate of good manufacturing compliance (GMP) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The certification was issued following an inspection of the HollisterStier facilities' quality systems and processes enables the manufacture of Investigational Medicinal Products for clinical trials, as well as the manufacture of a terminally sterilized diluent on the plant's new Small Volume Parenterals Line (SVP II). The SVP II unit is a new addition to the firm's state-of-the-art production facility. The line is available to aseptically fill liquid and lyophilized pharmaceutical products in vials ranging from 2mL through 200 mL in batch sizes from 20 to 3,000 litres. RxElite to supply API product to Hi-Tech​ RxElite has agreed a 10-year development, supply and marketing deal with Hi-Tech Pharmacal, a manufacturer and marketer of liquid generic products. Under the terms of the agreement, RxElite will supply active pharmaceutical ingredients (APIs) to be used in the manufacture of the generic ophthalmic product. The APIs will be manufactured by RxElite's wholly owned subsidiary, FineTech Pharmaceuticals, at its production facility in Nesher, Israel.

Hi-Tech Pharmacal will develop the finished dose formulation, and will take responsibility for all regulatory filings, and manufacture and marketing of the finished product. Upon commercialisation, the parties will share net proceeds from the sale of the product. San Jose hoping to tap into biotech boom with local CMO​ The city of San Jose in the US is hoping to lure a pharmaceutical contract manufacturer to its Edenvale Technology Park to help kick start the development of its fledgling biotechnology industry. San Jose's redevelopment agency is hoping to find $23m for the project with the help of state and federal funding. The recommendation to attract the CMO came from PharmaBioSource California, a consulting firm retained by the redevelopment agency to look into the feasibility of the move. At the moment the need to source manufacturing from elsewhere in the US or overseas is holding back the development of the biotech sector in San Jose, according to the San Jose Biocenter, which has 22 biotech tenants on the Edenvale campus. Dalton adds new LC-MS/MS instruments​ Dalton Pharma Services of Canada has expanded its contract analytical services offering with the introduction of two validated LC-MS/MS instruments, which have been qualified for GMP testing of drug products. The new equipment will assist in the identification, quantification of related substances, pharmaceutical degradation products and impurities to support the preparation of registration dossiers for clients' drug development programmes, said the firm. Medical House to supply autoinjector to Dr Reddy's​ UK-based drug delivery specialist the Medical House (TMH) has signed a non-exclusive development, licensing and supply agreement with India's Dr Reddy's Laboratories. Under the terms of the deal, TMH will customise its proprietary, patented ASI disposable autoinjector device technologyfor use with an undisclosed Dr Reddy's drug, to create a new self-injectable product. The accord covers an initial five-year term of supply, within the US, EU and Canada, with an option for Dr Reddy's to extend it to the rest of the world. First commercial supply of the customised ASI device is expected to be in 2009-10 and TMH will receive a technology access fee during the term of the agreement. Abeome and Cato to develop cancer MAbs​ Biotechnology firm Abeome has obtained an equity investment by Cato BioVentures and has established a collaboration deal with Cato Research, Cato's global contract research and development organisation. The investment and collaboration will support development of Abeome's lead ovarian cancer project. The firm's patented technology, which is designed to expedite the development of monoclonal antibodies (MAbs), is being used to develop an array of antibodies for an ovarian cancer

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