Different AAV serotypes (e.g., AAV8, AAV9, or engineered capsids) exhibit unique production kinetics and packaging efficiencies. A one-size-fits-all approach is ineffective. A tailored strategy that adjusts transfection parameters and cell culture conditions for a specific serotype is required to maximize vector titer and potency.
A successful AAV program is built on a foundation of robust and reproducible upstream processing. The transition from research-grade vector to a clinical candidate hinges on the ability to systematically optimize bioreactor conditions to enhance vector packaging, titer, and overall yield. A scientifically-driven process, tailored to each unique AAV serotype and its target indication, moves beyond standardized protocols.
At Franklin Biolabs, our approach focuses on key upstream variables within our Sartorius single-use bioreactor platforms.
* **Transfection Parameter Optimization**: We refine the ratios of plasmid DNA and transfection reagents to maximize vector genome packaging efficiency.
* **Media Selection and Feed Strategy**: Customizing media formulations and nutrient feeds supports high-density cell cultures, ensuring cell viability and productivity throughout the production run.
* **Bioreactor Control**: Precise control over pH, dissolved oxygen (DO), and agitation speed maintains an optimal environment for viral vector assembly.
This meticulous process development is informed by decades of experience. As one partner noted, this continuity is a significant asset for their program.
> “We started collaborating with UPenn Vector core in 2023 and the AAV vector which they manufactured laid a foundation for development of a gene therapy candidate which will enter soon preclinical studies. The key people from UPenn Vector Core joined Franklin Biolabs and our partnership transitioned without interruption… Franklin Biolabs provides the essential manufacturing and development support for our AAV-vector based gene therapy candidate, and we hope to continue this collaboration for years to come.”
> \- Biotech Partner
Our scientific leadership and core team’s track record, which includes a 100% successful IND rate since 2019, was established long before the formal launch of Franklin Biolabs in 2024. This history, which includes collaborations with organizations like our partners, is executed within our >100,000 sq ft facility, enabling programs to move from concept to IND-enabling studies on an 18-24 month timeline. For a deeper look into capsid selection and scalability, view our technical webinar.A high-titer vector is only valuable if it performs as expected in a translationally relevant context. Preclinical data (PMID: 32420410) from nonhuman primate models demonstrates that the route of administration and biological realities can present significant hurdles, even for a well-characterized vector. This finding underscores the need for an integrated strategy where upstream vector design is informed by the realities of the planned in vivo studies.
Our expertise extends beyond the bioreactor to encompass the entire development pathway, ensuring that the vector you produce is not only high in titer but also fit-for-purpose for your specific preclinical and clinical goals. This integrated view supports the preparation of comprehensive data packages for multi-jurisdictional IND and IMPD submissions.
For more information on our broader capabilities, explore our services in [Large-Scale AAV Manufacturing and Process Development](/large-scale-aav-manufacturing-and-process-development/).
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