Proven Intelligence Accelerating Next-Generation Therapies.

Executive Summary

The integrity of a viral vector is determined by its foundational plasmid DNA. A precisely engineered plasmid is the blueprint for capsid expression, payload delivery, and therapeutic efficacy. Franklin Biolabs provides bespoke cloning and plasmid generation services for AAV, lentivirus, and adenovirus vectors, building directly upon the decades of expertise established at the Penn Vector Core. Our process ensures that the starting material for your research-grade vector is sequence-verified, pure, and optimized for high-titer production, supporting programs from discovery through IND-enabling activities.

The Plasmid Blueprint: Foundational DNA for Viral Vector Efficacy

Successful viral vector production begins long before cell transfection. The design, cloning, and purification of the plasmid DNA dictate the quality, titer, and performance of the final vector. Errors or impurities at this initial stage can lead to failed production runs, inconsistent in vivo results, and delays in program timelines.

Our approach focuses on meticulous front-end preparation. We work with clients to design and construct plasmids that are optimized for specific viral vector systems, whether for AAV1, AAV8, AAV9, or custom-engineered variants. This includes codon optimization, selection of appropriate promoters and polyadenylation signals, and ensuring the integrity of inverted terminal repeats (ITRs) for AAV constructs.

From Penn Vector Core to Franklin Biolabs: A Continuum of Expertise

The core scientific team and established processes from the University of Pennsylvania’s Gene Therapy Program Vector Core have transitioned to Franklin Biolabs. This provides our UK and EU clients with uninterrupted access to the same technical expertise and proven platforms that have supported numerous advanced therapy programs.

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 collaboration transitioned without interruption from UPenn Vecor Core to Franklin Biolabs Research Vector Division. Franklin Biolabs provides essential manufacturing and scientific support for our AAV-vector based gene therapy candidate development, and we hope to continue the collaboration for years to come.
— Biotech Partner

Navigating Vector Design for Clinical Translation

Early construct design has significant implications for downstream preclinical and clinical outcomes. Data from large animal model evaluations informs our approach to vector engineering, helping to anticipate and mitigate potential hurdles. For instance, insights from liver-directed gene transfer studies (PMID: 21204705) underscore the need to carefully consider vector serotype and potential payload immunogenicity, which can be influenced at the plasmid design stage.

Understanding the biodistribution patterns associated with different routes of administration (PMID: 28806897) reinforces the importance of vector optimization. A well-designed plasmid is the first step in developing a vector that achieves targeted transduction while minimizing expression in non-target tissues, a key consideration for IMPD and MHRA submissions.

Our Custom Plasmid Generation Process

Our service is structured to provide both flexibility and scientific rigor, ensuring your project starts with the highest quality DNA material.

• Consultation and Design: We begin with a technical consultation to align on project goals, construct design, serotype selection, and final deliverables.

• Gene Synthesis and Cloning: We offer gene synthesis services or can work with client-provided material. Sub-cloning into our validated AAV, lentiviral, or adenoviral backbones is performed using standard molecular biology techniques.

• Amplification and Purification: Plasmids are amplified in E. coli and purified at midi, maxi, or giga scales using endotoxin-free kits to generate material suitable for subsequent transfection in GxP-compliant environments.

• Quality Control and Verification: All constructs undergo comprehensive QC, including sequence verification of the gene of interest and flanking regions, and analytical restriction digests to confirm plasmid identity.