Date: Nov 10, 2008 Source: (
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CLEVELAND -- NOVEMBER 10, 2008 -- Oakwood Laboratories, LLC, an emerging specialty pharmaceutical company focused on advanced injectable drug delivery, today announced it is offering contract manufacturing of parenteral products at Oakwood's state-of-the-art aseptic facility. The plant in suburban Cleveland underwent cGMP FDA inspection in 2007, with no 483s being issued. The facility currently manufactures injectable products for human trials. Oakwood expects Pre-Approval Inspection (PAI) for a commercial product during 2009.
Mark Smith, President and CEO, said: "Oakwood has the capacity and flexibility to move quickly and provide high-quality aseptic manufacturing. Because we are an entrepreneurial company, our partners work directly with a collaborative senior management team. Our team combines deep expertise in the technical aspects of sterile manufacturing, with decades of experience in contract manufacturing relationships. This new facility has produced small and commercial-scale batches, including supplies for Phase III trials of our lead product."
The Oakwood facility is equipped for all steps of parenteral drug manufacturing. It incorporates strict card key access, airlock pass-through and gowning policies for all employees, permitting full segregation of all critical manufacturing steps utilizing clean rooms of various classes (Class 10,000 with Class 100 working zones). Features include microbiology and analytical labs, aseptic formulation and filling rooms, and warehouse space. The facility can accommodate clinical supplies and commercial-scale lots of either liquid or lyophilized (freeze-dried) sterile products. Additional details are available at www.oakwoodlabs.com.
Oakwood will exhibit at the American Academy of Pharmaceutical Scientists (AAPS) Annual
Meeting, November 17-19 in Atlanta, Georgia (Booth #1062).
