Current Projects:

• Completed Oral Rotavirus Vaccine for Phase I Clinical Trials (PATH). [Exceeded titer spec by ~80%]
• Completed Phase I Dengue Vaccine for NIAID.
• Completed Phase I RSV Vaccine for NIAID.
• Starting Phase I r-RSV and r-PIV3/RSV Vaccine NIAID.
• Received task order for 2nd r-Dengue Phase I Vaccine, NIAID.
• Received task order for H1N1 influenza grown in eggs.
• cGMP manufacture of a Phase I divalent VLP vaccine made in the Baculovirus insect cell expression system.
• R&D contract to optimize a chromatographic purification process for live recombinant influenza vaccine(s).
• R&D contract to optimize cell culture conditions and chromatographic purification of a Hepatitis A vaccine.

NIAID Experimental Vaccines Contract:

Meridian Life Science, Inc. was awarded a five-year, $12.2 million contract by the National Institute of Allergy and Infectious

Diseases (NIAID) Laboratory for production of up to 10 experimental vaccines per year.  The contract requires production and safety testing of experimental non-Influenza, Influenza virus vaccines, and other vaccine-related products for use in humans.  Specific activities include:

1) Manufacture of viruses shown to be promising candidates for use in vaccination of humans.

2) Preparation of wild type viruses needed for challenge studies to evaluate effectiveness of immunoprophylaxis or in pathogenesis studies.

3) Manufacture and qualification of Master Cell Lines for production of these viruses or other uses as directed by NIAID.

Parovirus B19 Vaccine:

Meridian Life Science has manufactured, and subsequently licensed, a recombinant Parvovirus B19 vaccine under a contract from the National Heart Lung and Blood Institute of the National Institutes of Health.  The vaccine was manufactured according to cGMP in Meridian Life Science’s fully qualified Spodoptera Frugiperda (Sf9) insect cell line and is now in Phase I/II safety/efficacy trials.  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 Sf9 cells and that, upon expression, self assemble into immunogenic virus-like particles.  Meridian Life Science has a validated cGMP vialing line for this product of up to 2,500 vials.

RSV Clinical Challenge Stock:

Meridian Life Science has manufactured a cGMP Respiratory Syncytial Virus Clinical Challenge Stock (RSV M37) from an original pediatric clinical isolate.  The RSV M37 consists of an RSV high titer accession stock produced in characterized Vero cells infected with an RSV virus strain isolated from an original pediatric clinical sample.  RSV M37 recently shown to be infectious, enables precisely controlled clinical vaccine efficacy studies to demonstrate protection (vs. implied protection). For anti-viral therapeutics, the RSV M37 also allows for precisely controlled clinical studies to show therapeutic efficacy in eliminating or mitigating the effects of the disease in patients who have developed a controlled RSV infection as compared to control.