Pharma manufacturing news in brief
pharmafile | May 31, 2011 | News story | Manufacturing and Production |Â Â Aurobindo Pharma, Gallus, Lonza, ProMetic, UnigeneÂ
This week’s round-up of pharmaceutical manufacturing news includes new contracts for ProMetic and Unigene, plus facility updates from Aurobindo, Gallus and Lonza.
ProMetic Biosciences Ltd of the UK has been awarded a contract to improve the manufacturing process for a biologic drug developed by an unnamed multinational company. PBL, a subsidiary of Canadian company ProMetic Life Sciences will create an affinity resin product and associated manufacturing process conditions for the client, whose product is made in ‘multi-tonne quantities’. The agreement will provide ProMetic with initial service revenues of up to C$800,000 (€575,000) during 2011 and could lead to a long-term manufacturing agreement for the resin.
The US FDA has sent a warning letter to Indian drugmaker Aurobindo Pharma setting a deadline to bring a troubled antibiotics manufacturing facility in Hyderabad up to code. Earlier this year the FDA placed an import alert on the cephalosporin-producing Unit VI plant on the grounds of being out of compliance with packaging and labelling standards. The company is now seeking a meeting with the agency and will develop a remediation plan.
Unigene Laboratories will manufacture phase III clinical trial materials of Cara Therapeutics’ CR845, a peripherally acting kappa opioid agonist being developed as a treatment for both acute and chronic pain, under the terms of a new agreement between the two firms. The deal extends an earlier contract awarded to Unigene for the production of CR846 supplies for phase I trials, said the two firms.
US contract manufacturer Gallus BioPharmaceuticals is expanding its biomanufacturing capacity with the purchase of several FlexFactory production suites from Xcellerex, which specialises in single-use bioprocessing equipment. The deal includes disposable bioreactors from 10-litre to 2,000-litre scale. The agreement will also give Xcellerex’s customers access to a commercial,-scale FDA approved biomanufacturing facility, according to the two firms. The first manufacturing suite will be in place by the end of 2011, said Gallus.
Swiss contract manufacturer Lonza has said it plans to build a state-of-the-art GMP cleanroom for its viral-based therapeutics business in Houston, Texas. The cleanroom will include large-scale capacity to support late-stage viral vaccine and gene therapy projects, according to the firm. By utilising disposable process systems it will support production and fill/finish operations of up to 2000L. The expansion is expected to be complete by early 2012.
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