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Pharma manufacturing news in brief

Published on 17/02/14 at 01:37pm
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Hospira has made significant progress in restoring quality compliance at its facilities in Rocky Mount and Austin, which were the subject of warning letters issued by the FDA. Chief executive Michael Ball indicated on the firm's further-quarter results call that it has been advised by the FDA that the status of the plants has been changed to ‘voluntary action indicated’ or VAI, although he indicated the warning letters cannot be rescinded until a re-inspection occurs. He also indicated that Hospira's generic injectable pharma manufacturing facility in Vizag, India, will start commercial production in late 2014, while acquisition of an active pharmaceutical ingredient (API) plant from Orchid Pharmaceuticals should close around the middle of this year.

Shire has been granted FDA approval to manufacture the bulk drug substance for Vpriv (Velaglucerase alfa), its fast-growing treatment for Gaucher disease, at its facility in Lexington, Massachusetts. The approval will help ensure Shire can maintain supplies of the drug, which grew 12% last year to reach $343 million in turnover.

Catalent Pharma Solutions is expanding a facility in Kansas City, US, with a $30 million investment round that could create more than 230 new jobs. The 450,000 sq. ft. Kansas City plant provides formulation and development services, as well as analytical testing and clinical and commercial manufacturing for oral dosage forms. The prompt for the investment round is a contract to supply commercial quantities of Johnson & Johnson's blockbuster-in-waiting Imbruvica (ibrutinib), which has just been approved to treat chronic lymphocytic leukaemia (CLL) having been given the go-ahead for mantle cell lymphoma last year.

Alexion Pharmaceuticals has reached a deal to acquire a site in Athlone, Ireland, that will house a new vial-filling facility and supply chain operations that - when completed - will employ around 90 workers. The company has also named Julie O'Neill as vice president of global manufacturing operations and general manager of the new Irish facility. She joins Alexion from Gilead Sciences where she was vice president of operations and general manager for Ireland.

Advaxis has signed an agreement with SynCo Bio Partners for manufacturing of its lead cancer immunotherapy. Under the terms of the deal, SynCo will manufacture initial supplies of ADXS-HPV, and will also help Advaxis scale-up to commercial manufacturing processes for the product. ADXS-HPV is due to start registration trials as a treatment for recurrent cervical cancer later this year.

A new start-up company called Berkshire Sterile Manufacturing is in the process of raising capital to build a manufacturing facility in Massachusetts that would employ up to 90 people, according to the Berkshire Eagle newspaper. BSM will specialise in providing sterile production and filling services and intends to spend $4 million to $6 million retrofitting a facility. It is headed by former executives from Hyaluron, a company which operated a sterile facility in Burlington that was bought by contract manufacturing organisation (CMO) AMRI in 2010.

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