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Home » Services » Custom Assay Development » cGMP Biopharmaceutical Manufacturing |
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cGMP Biopharmaceutical Manufacturing
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Meridian Life Science, Inc. has a strong commitment to quality and regulatory compliance. We are flexible, and we understand that you may have requirements to be integrated into our existing documentation. Please contact us to discuss your needs for biopharmaceutical manufacturing. Our technical expertise, flexibility and commitment to quality is unsurpassed and can be used to move your product from the research laboratory to clinical testing without wasting time or financial resources. Proven Track Record People, Expertise and Facilities for Early Phase Production Cultures to 100 liters Disposable Bioreactor Technology __ Baculovirus Systems __ Stable Recombinants Purification by Conventional and Specialized Techniques Process Development Services __ Cloning Strategies __ High Level Production __ Media Optimization __ Purification __ Testing Methods Emphasis on Quality Experienced Regulatory Personnel Experience with Baculovirus Expression System Meridian Life Science, Inc. has been using Sf9 insect cells since 1990 for production of recombinant proteins using the baculovirus expression system. We have experience in cloning DNA into baculovirus vectors, purification of recombinant baculovirus, and production and purification of recombinant proteins from Sf9 cells. In addition, we have experience growing Drosophila melanogaster (D. Mel-2, also called S2) cells. Meridian Life Science, Inc. has also recently initiated a Phase I clinical trial for a recombinant Parvovirus B19 vaccine produced using the baculovirus expression system for the National Institutes of Health (NIH). Manufacturing of this vaccine requires precise co-infection of insect cells with two baculoclones such that the final virus-like particles self assemble into an immunogenic viral capsid. Meridian optimized the manufacturing and purification of the Virus Like Particles and produced materials to support the current Phase I clinical trials. |
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