CLEVELAND, Nov. 11, 2008 (GLOBE NEWSWIRE) -- 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 a 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).
About Oakwood Laboratories
Oakwood Laboratories, LLC is an emerging specialty pharmaceutical company focused on applying advanced injectable drug delivery. Oakwood is developing proprietary products based on our patented technology platform, CHRONIJECT(tm), a sustained-release microsphere formulation that enables a single injection to deliver drug for periods ranging from one week up to one year. Our development pipeline spans the therapeutic areas of oncology, endocrinology, CNS, dermatology, and ophthalmology. Oakwood also partners with pharmaceutical and biotechnology companies to apply our drug delivery technology to new chemical entities or to extend the patent life of existing products. Our manufacturing facility enables the production of clinical and commercial supplies of liquid and lyophilized parenteral products. Oakwood is located in the Cleveland area in the USA.
The Oakwood Laboratories, LLC logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5602