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Our Lexington facility houses state-of-the-art equipment in cleanroom suites specially designed to accommodate a broad-range of viral vector manufacturing process technologies. It boasts multiple drug substance suites able to support large-scale adherent and stirred tank production, an automated fill/finish system leveraging isolator technology, quality control laboratories, and process development space. The facility is designed with an HVAC system for grade C clean rooms, unidirectional flow, and a centralized vaporized hydrogen peroxide system to ensure suite sanitization.
Specialized Capabilities
This site produces and tests viral vectors for gene and cell therapy with adherent and suspension cell culture processes, a variety of chromatography and filtration purification processes and a state-of-the-art isolator and integrated fill system.
Our specialized capabilities include:
- Phase III and commercial viral vector supply of AAV, Lenti, Adeno, HSV and Retro
- cGMP analytical method expertise including method validation
- Process transfer and scale up
- Process validation lifecycle including PC, PPQ and CPV
- cGMP Cell Banking
- cGMP Cell Culture capabilities from adherent to suspension
- State-of-the-art commercial cGMP aseptic fill and finish
Learn more about the specific equipment and capabilities at this site by downloading our complete Site Fact Sheet.