Lentigen has a proven track record in viral vector product development and clinical application. Having worked with various regulatory authorities such as OBA/RAC, FDA and EMA, we are prepared to support you with all your regulatory needs regarding our services.
Lentigen provides letters of cross references to our lentiviral vector (LV) Biologics Master Files (BMF). Our current BMF includes a complete CMC section for LV manufacturing and is updated annually. Our facilities have been audited and accepted by large pharma/biotech companies.
The design, development and implementation of monitoring assays is essential for each therapeutic development program. We have strong expertise in each of these areas and are ready to develop additional assays for you.
Please contact our experts to discuss your needs.