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美國Meridian Biologics??
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About Meridian Biologics - "A Culture of Scientific Excellence"
Meridian Biologics is a new brand in the Meridian Life Science, Inc. (MLS) family that offers contract R&D and process development through to clinical cGMP biomanufacturing for therapeutic proteins (recombinant, antibodies, etc.), cell therapies, viral vectors, and vaccines. MLS has over 35,000 sq. ft. of GMP (according to CDRH guidelines) manufacturing space including a 3,000 sq. ft. cGMP clinical grade biotherapeutic and vaccine production facility. MLS can provide process development, scale-up, and downstream processing services to support vaccine production. MLS has experience producing clinical grade biotherapeutics and vaccines in our cGMP facility. The cGMP facility currently has up to 100L of cell culture and 75L fermentation capabilities. However, MLS can expand cell culture up to 2,000L of suspension culture in WAVE ? Bioreactors or up to 60L (per run) of attachment-based culture using Cell Factories. Representative projects include, but are not limited to:

? Parvovirus B19 Vaccine: MLS recently completed the manufacture of a recombinant Parvovirus B19 vaccine that MLS has licensed from the NIH for Phase I/II safety/efficacy trials. The recombinant Parvovirus B19 vaccine is produced using the baculovirus expression system. The vaccine consists of two viral proteins (VP1 and VP2) in separate baculovirus vectors that are co-infected at the correct multiplicity of infections (MOI抯) into Spodoptera frugiperda (Sf9) cells and that, upon expression; self assemble into immunogenic virus-like particles.
? Viral Challenge Stock: MLS has manufactured a live virus under cGMP manufacturing guidelines to be used for a human clinical viral challenge study for the investigation of a new antiviral therapeutic. We were able to isolate and purify a specific virus from a human clinical isolate and then manufacture the stock.
? Biodefense Work: MLS provides R&D services and biomanufacturing of biodefense reagents and clinical trial standards for BEI Resources of the NIAID. For production of viral stocks, all personnel involved are vaccinated prior to working on any new virus where possible.
? Purification of anti-Anthrax Antibodies from rare human serum. This involves the creation of both a Proficiency Panel and Quality Control Panel from serum.
? Production of 40 monoclonal Abs to Vaccinia from Hybridomas. We have adapted each of the hybridomas to serum free culture conditions.
? Expression of recombinant Vaccinia antigens from Baculovirus/Insect Cell System.
? β-Gal Vaccinia virus bank production: Generated sufficient virus to fill 60,000 vials for this virus bank. Filling was done at MLS.
? Vaccinia virus bank production: Smaller scale run similar to β-Gal Vaccinia virus run but with different Vaccinia strain.

Meridian Life Science, Inc. is a high quality supplier of antigens, antibodies - both polyclonal antibody and monoclonal antibody, serum proteins, immunoglobulins, biologicals, and contract R&D and manufacturing services. Our antigens and antibodies are used by researchers and diagnostic companies in assay development while our contract manufacturing of proteins and other biologicals are used by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.
Meridian Life Science, Inc. currently focuses on the development, manufacture, sale, and distribution of bulk antigens and reagents used by researchers and other diagnostic companies, as well as the contract manufacturing of proteins and other biologicals used by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.

Growth strategies for Meridian Life Science include: (i) developing new product applications from existing technologies; and (ii) acquisition or licensing of biologicals and technologies for development of new products.

Contract manufacturing of proteins and other biologicals for biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines is an example of significant new product application built from Meridian's existing expertise in manufacturing bulk antigens and reagents using cell culture techniques. This business will focus on contract manufacturing of materials that will be used in Phase I and II clinical trials. In July 2005 Meridian was awarded the exclusive global license for the Recombinant Parvovirus B19 vaccine technology from the National Institutes of Health (NIH). In 2006 Meridian completed the production of the Parvovirus B19 vaccine for the NIH and received clearance to initiate Phase I clinical trials with the material in Q1 of 2007.

In 2007, Meridian completed manufacturing of a clinical infectious inoculum of respiratory syncytial virus (RSV) for Alnylam Pharmaceutical’s human clinical trials. Meridian is currently negotiating with several additional biopharmaceutical companies for the production of recombinant proteins for use in therapeutic agents and vaccines. These materials are intended to be used as "injectibles." As such, they will be produced under cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA.

Meridian expects that its Life Science operating segment will serve as a key platform for sourcing biologicals and technologies, by acquisition or license, for development of new products for all of Meridian's operating segments. One of Meridian's specific strategies in this area is to target biologicals that have commercial product applications across multiple markets, such as human diagnostics, veterinary diagnostics and therapeutics. This strategy is expected to leverage research and development resources as products can be developed with all three markets in mind, rather than on a market-by-market basis.

The Life Science operating segment has targeted three primary market segments for its products and services: bulk biomedical reagents, drug and vaccine discovery, and drug and vaccine development. The customer base for bulk biomedical reagents is large and fragmented, and includes other diagnostic manufacturers as well as researchers in academia and the pharmaceutical and biotechnology industries. The market segments for drug and vaccine discovery and development are intended to be served via contract manufacturing in the protein production laboratory discussed above.
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