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Large-Scale AAV Manufacturing and Process Development
Franklin Biolabs delivers quality large-scale AAV production supported by rigorous process development.
Certain vector manufacturing capabilities previously provided by the Penn Vector Core of the Gene Therapy Program at the University of Pennsylvania have been acquired by Franklin Biolabs, and such services are now available via Franklin Biolabs.
Scaling Up for Success
Franklin Biolabs specializes in producing AAV vectors at scales that support a wide range of clinical development programs. Our manufacturing platforms are designed to be highly flexible and robust, enabling production through both adherent and suspension processes. Building on success at the proof-of-concept stage, the experts at Franklin enable the production of sufficient material for IND-enabling studies and the generation of critical data needed to meet global regulatory requirements. Utilizing an integrated approach that ensures seamless execution from preclinical to GMP production, Franklin can effectively mitigate risks and reduce delays associated with advanced therapy development.
Process Development
With cutting-edge technology, a data-driven approach, and an experienced team committed to quality and compliance, Franklin Biolabs will effortlessly transform your research-scale protocol into an optimized, scalable manufacturing solution.
We offer tailored process development services to advance your AAV vector from research to large-scale production. Serotype-specific optimization for natural and engineered serotypes is available in addition to process refinements to enhance vector packaging and titer.
- Upstream Process Development
- Transfection parameters
- Media selection and feed strategy
- Scale-up confirmation runs
- Downstream Process Development
- Platform-based or client-specific purification methods to meet quality and regulatory requirements
- QC Analytics
- Over 20 platform assays available, including titer, purity, %full, and residual and impurity testing
- Design, development, and qualification of gene-of-interest-specific ddPCR assays
- Specialized expertise in development and qualification of AAV cell-based potency assays to support clinical development
Learn more about our analytical testing services here
Suspension and Adherent AAV Production Platforms
Franklin Biolabs offers robust, scalable, high-yield suspension and adherent AAV production platforms to meet the diverse needs of gene therapy developers. Our large-scale platforms and GMP-comparable process consistently deliver potent AAV vectors to accelerate the transition from development to clinical application.
SUSPENSION
- Franklin uses Sartorius single-use bioreactors designed specifically for suspension culture systems, ensuring minimal contamination risk, rapid setup, and prompt turnaround.
- Flexible batch sizes are available ranging from 2L to 500L+ in single-use bioreactors.
ADHERENT
- Franklin uses innovative iCELLis® fixed-bed bioreactors and scale-X™ structured fixed-bed systems engineered to enhance productivity and optimize adherent cell growth conditions.
- Flexible batch sizes are available ranging from 2.4 m2 to 200+ m2 fixed-bed adherent bioreactors.
GMP Manufacturing
Choose Franklin Biolabs to accelerate your advanced therapy with confidence. Our established platform methodology shortens tech transfer timelines, streamlines document preparation, and achieves material readiness for GMP production. Unlike other organizations, Franklin Biolabs provides peace of mind and process knowledge continuity by engaging the same team that worked on early process development and preclinical production to execute GMP manufacturing at a strategic partner’s CDMO GMP suite.
Franklin Biolabs also excels in collaborative flexibility, having successfully supported technology transfers to external CDMOs upon client request, provided Person-in-Plant (PIP) services as needed, and offered comprehensive strategic recommendations on Chemistry, Manufacturing, and Controls (CMC) to optimize clinical development. Whatever the project, the team at Franklin can provide a seamless scale-up experience.
Want to Accelerate Your Program?
Check out our in vivo preclinical services, including specialized routes of administration, biodistribution, and toxicology studies to evaluate your novel gene therapy.
Getting Ready to Enter the Clinic?
Check out our bioanalytics page for more information on how Franklin Biolabs can advance your gene therapy from discovery to commercialization.
Preparing to Scale Up Your AAV Program?
Contact us for expert guidance and customized manufacturing services tailored to your goals.
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