Lexington, Massachusetts, USA

Lexington, Massachusetts

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.

Location Image

45 Hartwell Avenue
Lexington, Massachusetts 02421
Phone: +1 781-266-0200