Search   |   Advanced Search   |   Help
 

Home » Services » Custom Assay Development » cGMP Biopharmaceutical Manufacturing

cGMP Biopharmaceutical Manufacturing

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.

Baculovirus Expression
Stable Recombinant Expression
Production to 100L Using Disposable Bioreactor Technology
Process Development and Optimization
Cloning, Upstream, Downstream and Test Methods
Flexibility to Meet Your Protein Needs
Copyright © 2007 Meridian Life Science,® Inc.