A Scalable Foundation for Preclinical In Vivo Programs

Executive Summary

High-quality plasmid DNA is the foundational starting material for producing recombinant AAV, lentivirus, and adenovirus vectors. The presence of endotoxins or other impurities in plasmid preparations can compromise downstream manufacturing yields, reduce viral vector potency, and introduce confounding variables into preclinical in vivo studies. Our DNA services provide meticulously purified, sequence-verified, and endotoxin-free plasmid DNA, engineered to de-risk vector production and ensure the integrity of your translational data.

Frequently Asked Questions

What are the typical endotoxin limits for plasmid DNA intended for in vivo research?

For direct in vivo use or for manufacturing viral vectors for preclinical studies, plasmid DNA should contain exceptionally low levels of endotoxin, typically below 0.1 Endotoxin Units (EU) per microgram of DNA. This minimizes the risk of inflammatory responses that could affect study outcomes.

How does plasmid quality impact AAV vector production?

Plasmid purity, integrity, and topology directly influence the efficiency of transfection and subsequent viral packaging. Contaminants can reduce cell viability and packaging efficiency, while errors in plasmid sequences, particularly within the ITRs, can lead to truncated or non-functional vectors, compromising the final product’s quality and titer.

What scales of plasmid DNA production do you support?

We provide a flexible range of production scales to support programs from early discovery through IND-enabling studies. Our services scale from milligram quantities for initial vector screening to multi-gram lots required for large-scale vector manufacturing runs.

What quality control is performed on research-grade plasmid DNA?

Every batch of plasmid DNA undergoes a comprehensive panel of analytical QC tests before release. This includes A260/A280 spectrophotometry for purity and concentration, restriction enzyme digestion to confirm identity, and full-plasmid sequencing for sequence verification. A quantitative Limulus Amebocyte Lysate (LAL) assay is performed to certify low endotoxin levels.

Building a Reliable Starting Point for Vector Manufacturing

The quality of a viral vector is determined long before cell culture and purification. It begins with the fidelity of the plasmid DNA used as its template. From our >100,000 sq ft facility, we focus on producing plasmid DNA that provides a stable and reliable foundation for vector development, helping our partners navigate the typical 18-24 month timeline to IND.

Our process is built on three pillars:

• Sequence Integrity: We employ rigorous sequence verification to ensure that every element of the plasmid: from the inverted terminal repeats (ITRs) to the promoter and transgene: is correct. This level of verification provides the high-fidelity genomic intelligence for advanced therapeutics necessary to prevent costly production failures.

• High Purity: Our purification process is optimized to remove contaminants that can inhibit downstream processes. This includes the removal of host cell DNA and proteins, resulting in a highly pure plasmid preparation that maximizes transfection efficiency in adherent or suspension cell platforms.

• Low Endotoxin Levels: Endotoxins are a primary source of concern for any reagent used in vector manufacturing. Our process incorporates specific steps to remove and deplete endotoxins, followed by stringent LAL testing to confirm that final products meet specifications for preclinical research.

This focus on quality and continuity is a hallmark of our approach. As a biotech collaborator recently noted, “The key people from UPenn Vector Core joined Franklin Biolabs and our work transitioned without interruption… We rely on Franklin Biolabs for our AAV-vector based gene therapy candidate development and hope to continue the collaboration for years to come.”

This commitment to GxP-level standards, combined with a 100% IND approval success rate for programs we have supported since 2019, underscores our role in preparing sponsors for regulatory review. While Franklin Biolabs as a brand launched in 2024, our team’s legacy of scientific and operational excellence provides a direct path for advancing complex vector programs.