Meridian Life Science is a premier manufacturer of critical reagents for the in-vitro diagnostic industry and a contract manufacturer for the biopharmaceutical industry.
The company operates a cGMP manufacturing facility in Memphis, Tennessee. Formerly known as Viral Antigens, the facility was established in 1982 and acquired by Meridian Life Science in March 2007.
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The facility was expanded in August 2009 and prepared to perform projects based on mammalian and insect cell culture along with virus production in eggs. Several phase I clinical vaccine development campaigns are performed in this facility.
The expanded facility has increased the company’s flexibility to better serve customers seeking contract manufacturing assistance for their biopharmaceutical or in-vitro diagnostic projects. Currently operating with 70 employees, the facility is certified by the USDA, QSR and ISO 9001. It is also FDA-CDRH audited and customer audited.
Expansion
The expansion saw the addition of a new cell culture and viral production suite to the facility. An independent and fully equipped sterility suite was also added to improve the in-house testing capabilities of the facility for incoming materials and finished products.
As part of the expansion, the pilot production lab was extended to support the requirements of the expanded cGMP facility and the existing vaccine manufacturing facility. The extended pilot production lab is equipped with space to study viral kinetics, harvest conditions and cell/virus expansion capabilities.
The expansion allows the facility to conduct simultaneous production runs of two separate cGMP vaccine or biopharmaceutical products. Additional capacity will allow Meridian to meet the increased demand. Multiple manufacturing contracts to be performed by the expanded facility include a live oral rotavirus vaccine, a divalent virus-like particle vaccine, and contract research and development (R&D) for a live recombinant influenza vaccine program.
A $2.5m ongoing expansion will create an R&D centre, increase contract manufacturing laboratories for in-vitro diagnostic contracts, and expand the warehouse and freezer farm space. This expansion is scheduled for completion in June 2011.
Facilities
The Memphis facility is a 45,000ft² building with multiple clean suites for phase I/II biopharmaceuticals as well as antigen and monoclonal antibody manufacturing for in-vitro diagnostics. The non-cGMP area constitutes 40,000ft², while the cGMP area makes up 3,600ft². Two suites are present for cell culture and vaccine production, namely the Dorsett clean room suite that measures 3,200ft² and the new 800ft² Naegele clean room suite. Both the existing suites and the newly added clean room suites have been named after the founders of Meridian’s Memphis business, Dr Preston Dorsett, Ms Karen Dorsett and Dr Robert Naegele respectively.
The newly added sterility suite and the expanded vaccine pilot production lab together constitute approximately 800ft² of space.
The facility additionally houses research and development labs, QA offices, QC labs, Class 10,000 clean room support areas and a class 10,000 purification area. There is also dedicated space for a warehouse, break room, equipment room, glassware prep, administrative areas, production offices and walk-in coolers.
The facility is designed with a dedicated heating, ventilation and air conditioning system and facilities to provide storage at varying temperatures including 70°C, -20°C, 4°C and room temperature.
Equipment
The cGMP area is equipped with four wave bioreactors with a combined capacity of 100l (25l each). The bioreactors can operate in batch, fed-batch and perfusion modes. Additional equipment for cell culture and egg incubation (for both non-cGMP and GMP) include shaker flasks, 1000 cell-line flasks, culture flasks, smooth or ridged roller bottles (up to 1,500 bottles are processed weekly for diagnostic antigen production), up to 30l spinner flasks, up to 40 10 x 10 cell factories and SPF egg incubator for up to approximately 300 eggs.
The facility is additionally equipped with disposable bioreactor bags, dedicated ÄKTApilot™ and ÄKTAready™ purification systems, centrifuges and a microfluidiser. A Class 100 downdraft hood is also installed.
Production
The facility develops more than 75 products including purified viral antigens, monoclonal antibodies and recombinant proteins. It also undertakes production and distribution of critical immunoassay reagents used by researchers, and diagnostic and biopharmaceutical companies.
