• Navigating German Biosafety Regulations with Precision Vector Analytics*

How do you align study design with German biosafety requirements (GenTSV)?

Our study designs are built from the ground up to comply with the German Genetic Engineering Safety Ordinance (GenTSV) and guidelines from the Central Committee on Biological Safety (ZKBS). We incorporate specific endpoints for vector shedding in excreta and secretions, define containment protocols, and generate a comprehensive data package tailored for submission to German authorities, including the Paul-Ehrlich-Institut (PEI).

What analytical methods are used to quantify vector biodistribution and shedding?

We primarily utilize quantitative PCR (qPCR) and droplet digital PCR (ddPCR) to provide sensitive and precise quantification of vector genomic DNA in a comprehensive panel of tissues and fluids. These bioanalytical methods are fully validated under GxP guidelines to ensure data integrity and regulatory acceptance. This is supplemented by high-resolution Histology to confirm tissue-level expression and assess local safety.

Can you accommodate novel AAV serotypes or modified viral vectors?

Yes. Our platform is vector-agnostic. We develop and validate custom qPCR or ddPCR assays for proprietary AAV capsids, lentiviral vectors, or other novel constructs. This ensures that the analytical methods are specific and sensitive for your unique therapeutic candidate, providing accurate biodistribution profiles regardless of the vector design.

How is sample collection for shedding studies managed to prevent cross-contamination?

Shedding studies require meticulous sample collection protocols. Animals are housed in specialized caging systems that facilitate the separate collection of urine and feces. All collection, processing, and storage procedures are executed under strict aseptic techniques by highly trained personnel to eliminate the risk of environmental or cross-sample contamination, which is a key focus for regulatory review.

To secure clinical trial authorization in Germany, viral vector gene therapy programs must provide a robust characterization of biodistribution and shedding. Franklin Biolabs executes GxP-compliant in vivo studies that generate the precise data required by German regulatory bodies like the PEI. We design and validate vector-specific qPCR and ddPCR assays to quantify vector dissemination and clearance, providing a clear safety profile that directly supports your Investigational New Drug (IND) or Clinical Trial Application (CTA) submission.

Submitting a CTA in Germany requires a data package that rigorously addresses the specific biosafety concerns outlined in the GenTSV. Regulators demand a clear understanding of where the viral vector distributes following administration and the extent to which it is shed from the body. An incomplete or ambiguous dataset can lead to significant delays.

Our approach focuses on generating definitive answers to these regulatory questions.

• Vector Biodistribution: We assess vector DNA presence across a full panel of target and non-target tissues to establish the vector’s tissue tropism and persistence. This aligns with insights from foundational studies, such as those confirming expected liver sequestration of AAV8 vectors, which provides a baseline for evaluating the safety profile of liver-directed therapies (PMID: 24070336).

• Vector Shedding: We quantify vector clearance in urine, feces, saliva, and other relevant biological matrices over time. This data is used to define the window of potential environmental transmission and inform clinical safety protocols.

• Route-Dependent Analysis: The route of administration profoundly impacts biodistribution and potential safety signals. As demonstrated in large animal studies, different delivery methods can yield vastly different outcomes, even with similar transduction goals (PMID: 28806897). Our study designs meticulously control for administration route to generate clinically relevant data.

“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 from UPenn Vecor Core to Franklin Biolabs Research Vector Division. Franklin Biolabs is our trusted partner in our AAV-vector based gene therapy candidate development and we hope to continue the partnership for years to come.”
— Biotech Partner

Our >100,000 sq ft facility is equipped to handle complex in vivo studies for viral vectors under stringent GxP compliance. We provide the robust in vivo data for complex modalities necessary for a successful regulatory filing. This commitment to quality, embodied by our core scientific team, has contributed to a 100% IND/CTA success rate for client programs since 2019 (the Franklin Biolabs brand launched in 2024), helping them navigate the typical 18-24 month IND timeline more predictably.

Our program is fully accredited by AAALAC and registered with the USDA. We rigorously apply the principles of the 3Rs (Replacement, Reduction, and Refinement) in every aspect of study design and execution.

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