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:
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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’s) 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. |
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About Meridian Biologics - "A Culture of Scientific Excellence"