Creating a complex IND whilst safeguarding confidential data between a CGT spin-off and CDMO

Published on: Feb 2nd, 2024

When submitting and IND for CGT product/therapy, it’s crucial to confirm that the viral vector in use is appropriate, especially when it’s produced by a third-party organization.

In this case study, we explore how VCLS supported a US-based company trying to gain IND for its cell and gene therapy. We served as the Client’s third-party contact with the CDMO, evaluated and discussed the Client’s specific areas of concern MCB control strategy, conducted analytical development, and kept close communication with the Client and CDMO while maintaining confidentiality during the assessment.