Manufacturing and Analytical Controls for IND-Enabling Programs
Producing lentiviral vectors for clinical applications demands robust manufacturing processes and rigorous analytical characterization. Our scientific team, whose track record includes a 100% successful IND rate since 2019, brings deep expertise to this process. It is this core team of principal scientists and study directors, now at Franklin Biolabs since our 2024 launch, that ensures continuity of quality and regulatory success.
Our approach includes:
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Scalable Suspension Platforms: We utilize scalable production systems to ensure a consistent supply from early preclinical studies through to clinical manufacturing.
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Phase-Appropriate Analytics: A comprehensive suite of assays is used to characterize each vector lot for identity, purity, potency, and integrity. This includes ddPCR for vector genome titering, p24 ELISA, and cell-based functional assays.
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Immunological Insight: Understanding vector biology is fundamental. While LV vectors for ex vivo use have a different immunological profile than in vivo administered vectors, our broad expertise in vector-host interactions informs risk assessment. For instance, insights from AAV immunology, such as the mechanisms of T cell exhaustion (PMID: 23778424), provide a framework for evaluating potential immune responses in any advanced therapy program.
Our >100,000 sq ft facilities are designed to support these complex workflows, from vector production to downstream bioanalytical testing. A tour of our laboratories is available here:. This integrated environment allows for efficient technology transfer and program execution. As one partner noted, our team possesses “Vast knowledge in all aspects of vector production and analytics.”
For programs advancing toward clinical evaluation, our manufacturing and testing are performed in GxP-compliant environments to meet US FDA regulatory standards. This ensures that the material produced is suitable for use in pivotal IND-enabling toxicology studies.
Our expertise extends across multiple viral vector platforms. For details on our AAV capabilities, see our AAV Research Vector Packaging Services.
