Meridian Life Science, Inc. has multiple, state of the art, cGMP production suites designed to meet FDA requirements for cGMP biopharmaceutical manufacturing. Meridian Life Science has proven experience manufacturing viral based clinical products. With over 25 years of cell culture, virus production, protein purification, assay development, and regulatory compliance; Meridian Life Science is your trusted partner for:
- Contract R&D
- Process Development
- Phase I/II cGMP Biomanufacturing
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cGMP Clinical Production Facilities:
- Multiple clean-rooms for Phase I/II biopharmaceuticals
- Flask, spinner flasks, roller bottle, cell factories, and disposable bioreactor bags
- SPF egg incubators
- Class 10,000 support areas and class 10,000 purification area
- Class 100 downdraft hood
- Dedicated ÄKTApilot™, centrifuges, microfluidizer
- Dedicated HVAC systems
- Dedicated storage at -70ºC, -20ºC, 4ºC, and room temperature
- Validated facility
- Cleaning validation
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