Manufacturing news in brief
This week’s rundown of manufacturing news includes a delay for Mannkind’s inhaled insulin product Afrezza, more job losses at Pfizer and updates from Genzyme, Transgene Biotek, Cel-Sci, ACell and Viva Pharmaceutical.
The US Food and Drug Administration (FDA) has said it will not be able to complete the review of MannKind‘s inhaled insulin product Afrezza by the action date of 16 January because it has not yet completed its inspection of the insulin manufacturing facilities at Organon which will supply the active ingredient. MannKind’s US marketing application for Afrezza makes reference to Organon’s drug master file (DMF) for recombinant human insulin.
US pharmaceutical giant Pfizer is planning to lay off another 116 employees at its Pearl River manufacturing facility in Rockland, New York, as part of its ongoing restructuring exercise implemented in the wake of its $68 billion merger with Wyeth. Last December Pfizer said it planned to downsize the former Wyeth plant by around 200 staff.
Genzyme has boosted its quality control expertise by hiring industry veteran Ron Branning as its new senior vice president of global product quality. Branning has 30 years’ experience working at the likes of Johnson & Johnson, Genentech and Gilead Sciences, and will have the task of getting Genzyme’s manufacturing back on track after a series of quality issues at its Allston Landing facility.
Transgene Biotek of India has sold a license to manufacturing technology used to make the weight-loss drug orlistat to Dr Reddy’s Laboratories. The intellectual property covers a novel way of making the active pharmaceutical ingredient (API), according to TBL. Orlistat is a lipase inhibitor is sold outside India by Roche, the compound’s original developer, as Xenical. GlaxoSmithKline also sells orlistat as an over-the-counter product under the Alli brand name.
US biotechnology firm Cel-Sci has completed the validation of its Good Manufacturing Practice (GMP) manufacturing facility in Baltimore, Maryland, USA, will be used to make clinical supplies for a phase III study of its immunotherapeutic product Multikine (mixed naturally-derivedcytokines) in head and neck cancer. Cel-Sci also intends to offer 4°C cold fill services on a contract basis from the facility, and is thought to be the only company to do so in the US.
Regenerative medicine company ACell is planning to open a US manufacturing facility in Winston Salem, North Carolina, but only if it can raise $15-30 million in funding. The privately-held firm has developed cell-based medical devices to help repair damaged tissues and organs and already operates a manufacturing plant in Lafayette, Indiana.
Canadian contract manufacturer Viva Pharmaceutical is planning to spend C$12 million building a manufacturing facility in Brunei that will supply halal medicines for the Muslim world, according to a report on the BruDirect.com website. The project is said to be in the final stages or agreement, according to the report, which cites Canada’s High Commissioner Wendell Sanford.
Pfizer has announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee …
Valneva and Pfizer have announced positive paediatric and adolescent immunogenicity and safety data for their …