Pharma manufacturing news in brief
pharmafile | May 10, 2010 | News story | Manufacturing and Production |Â Â American Peptide, DSM Biologics, Dutch CMO SynCo Bio Partners, KV Pharmaceutical, Merck & Co, manufacturingÂ
This week’s round-up of pharmaceutical manufacturing news includes facility updates from KV Pharmaceutical, DSM Biologics, Merck & Co and American Peptide, as well as a new contract for Dutch CMO SynCo Bio Partners.
Generic drugmaker KV Pharmaceutical says that an independent consultancy company has certified that its manufacturing operations in St. Louis, USA – currently under scrutiny by the FDA over quality problems – are now in compliance with Good Manufacturing Practice (GMP) standards. The independent certification was a condition of an FDA consent decree issued earlier this year and puts the firm on track to resume shipments before the end of the year.
DSM Biologics of the Netherlands has signed a preliminary agreement to build and operate Australia’s first major mammalian biopharmaceutical manufacturing facility in Brisbane, Queensland. The 70,000-plus sq. ft. facility will offer mammalian process development and clinical and commercial manufacturing services and is expected to be operational by 2013. Trade group Medicines Australia said the facility would allow more biopharmaceutical R&D to be carried out within Australia rather than offshore.
Merck & Co says it plans to start construction of a 40,000-square-foot laboratory at its vaccine manufacturing facility in Durham, North Carolina, in August, according to a report on NewsObserver.com. The lab is scheduled to open in 2012 and will employ up to 60 staff, adding to the 275 people already working at the plant.
American Peptide Co says it has expanded its production facility in Vista, California, with four new purification suites already in place, and two additional synthesis suites for solid and liquid phase production in the pipeline. APC also intends to add more lyophilisation capacity at the plant. The company said the investment means that it can now handle much larger-scale production contracts.
SynCo Bio Partners of the Netherlands says it has won a contract to manufacture two additional cancer antibody products for OncoMed Pharmaceuticals. The CMO is already manufacturing OncoMed’s OMP-21M18, a candidate drug for solid cancers, and will now also make clinical trial materials (CTM) for two other investigational antibodies at its fill-and-finish facility in Amsterdam.
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