INFORMATION
For Trade Press Release Only
January 23, 2009
Contact: 513.271.3700
Richard L. Eberly
Meridian Life Science announces expansion of cGMP Facility
Meridian Life Science®, Inc. (MLS) Cincinnati, Ohio, today announced that construction has started on a planned expansion of the cGMP biopharmaceutical manufacturing facility located in Memphis, Tennessee. The expansion will provide Meridian with an additional cell culture and viral production suite for the manufacture of clinical Phase I vaccines and viral based products. Additionally, a separate sterility suite will be constructed to enable testing of incoming materials and finished products further enhancing our in-house testing capabilities. This expansion provides Meridian with the capability to conduct multiple cGMP vaccine or biopharmaceutical product production runs simultaneously. The new production suite is scheduled to be operational by May 2009. Ongoing construction will not impact current operations in our existing cGMP facility.
The expansion was necessary to support increased demand of Meridian’s biopharmaceutical manufacturing services and to provide continued support for Meridian’s five year contract with the NIAID for the production of up to 10 Phase I viral vaccines per year. Currently, Meridian has also secured contracts for the production of a live oral Rotavirus Vaccine, a divalent Virus-Like Particle vaccine, and contract R&D for a live recombinant influenza vaccine program.
Richard Eberly, President of Meridian Life Science, commented, "The cGMP facility expansion is necessary to support increased interest in our core biopharmaceutical and vaccine production capabilities. The new facilities will allow us to provide greater flexibility for our customers and increase the overall number of projects we can undertake in a given year. The expansion reflects Meridian’s commitment to being the leader in Phase I/II cGMP contract manufacturing of viral based products and recombinant proteins and leverages our 23+ years of core virology expertise and experience.”
Meridian’s primary focus for cGMP manufacturing includes cell and viral banking, live attenuated or recombinant viral vaccines, viral challenge materials, virus like particle vaccines, vectored gene therapy products, and other recombinant proteins made in mammalian or insect cell culture. Meridian provides supporting services such as contract Research and Development, upstream and downstream process development and optimization, scale-up, formulations, assay development, viral quantitation, and clinical fill and finish.
ABOUT MERIDIAN LIFE SCIENCE:
Meridian Life Science, Inc. provides contract R&D, process development, and clinical cGMP biomanufacturing of vaccines, viral challenge materials, gene therapies, virus-like particles, and recombinant proteins at its contract biopharmaceutical manufacturing facility in Memphis, TN. This business focuses on materials that will be used in Phase I and II clinical trials that are intended for use as "injectables." As such, they are produced under cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA. With 25 years of cell culture experience, virus production, purification, assay development and quality, Meridian has become a leader and trusted partner for Phase I-II cGMP biomanufacturing solutions. Meridian also supplies critical assay reagents, antigens, antibodies, and contract biological R&D and manufacturing services to the research, diagnostic, and biopharmaceutical markets. Meridian Life Science services its customers from three primary manufacturing operations in Memphis, Tennessee; Saco, Maine; and Boca Raton, Florida. The Company’s shares are traded through NASDAQ’s Global Select Market, symbol VIVO. Meridian’s website address is www.meridianlifescience.com.
FOR ADDITIONAL INFORMATION CONTACT:
Daniel A. Shelly, Ph.D., MBA, Director of Marketing and Business Development, 513.271.5266