Walter E. Washington Convention Center
Washington, D.C.
May 16-19, 2022

Forecyte Bio USA Limited  

Frederick,  MD 
United States
https://forcytebio.com/
  • Booth: 365


Welcome to Forecyte Bio, Your Trusted CDMO Partner for CGT

As a CDMO focusing on the CGT industry, Forecyte Bio offers a “one-stop” holistic service package to accelerate clients’ projects from early concept to IND filing and eventual commercial manufacturing.

Our service covers a wide range of CGT products including plasmids, viral vectors (AAV, AdV, LV, Oncolytic virus, and Retrovirus), as well as cell products (CAR-T, TCR-T).  We work closely with clients to provide process development/optimization, to prepare CMC documentation for IND, to conduct clinical manufacturing, to support BLA filing, and to perform commercial manufacturing.

Our US and China facilities both offer process development and GMP production capabilities to provide coherent services for clients looking for multi-national studies. We build our service on decades of CGT CMC processes and production experience and expertise from our core technical experts.


 Products

  • Comprehensive CDMO Service
    Forecyte’s comprehensive CDMO service provides critical pre/post clinical and commercial material supply, including plasmids, viral vectors, and cell products; offers process development and GMP production; and supports CMC regulatory document filing....

  • Forecyte’s comprehensive CDMO service covers the life cycle from research to clinical to commercial:

    • Early-stage project services: vector construction, research-grade material production
    • GMP clinical manufacturing: tech transfer, process development/optimization, and GMP clinical manufacturing
    • Analytical services: analytical method development, qualification, and lot release and stability testing
    • Commercial manufacturing capability
    • CMC regulatory consulting and filing
    • Wide range of products: Plasmids, Viral Vectors, Cell Products, and mRNA

    Forecyte’s service is based on the broad expertise of its technical team and its state-of-the-art capabilities:

    • Decades of CGT CMC product development and GMP manufacturing experience
    • Strong technical team with decades of hands-on working experience at world-renowned CGT CDMO companies
    • Established Quality System compliant with International Regulations
    • Extensive regulatory filing experience; filed more than a dozen IND/CTA and a BLA
    • Facilities established in US and China, enabling multi-national regulatory filings and studies