Franklin Biolabs Achieves CLIA Certification for AAV NAb Testing
Learn more

MHRA Compliant Research Vector Production

PROVEN INTELLIGENCE IN RESEARCH-GRADE VECTOR MANUFACTURING.

MHRA-Compliant Research Vector Production for ATMP Development

CELL & GENE | RNA | BIOLOGICS

Executive Summary

For UK-based sponsors of Advanced Therapy Medicinal Products (ATMPs), the selection and production of research-grade viral vectors are foundational to a successful Investigational Medicinal Product Dossier (IMPD) submission to the MHRA. This requires a vector production strategy that anticipates regulatory scrutiny regarding purity, identity, and potential long-term biological effects. Franklin Biolabs provides research vectors, including Adenovirus and Lentivirus, manufactured with the analytical rigour necessary to support future GxP-compliant programs. This work leverages a scientific team with a history of contributing to a 100% successful IND rate since 2019, prior to the formal launch of Franklin Biolabs in 2024.

A marketing fact sheet from Franklin Biolabs about the scientific benefits of Mauritian cynomolgus macaques for preclinical research, featuring a photo of the primates.

Frequently Asked Questions

How does research-grade vector quality impact future MHRA submissions for an ATMP?

The quality of early-stage research vectors establishes the foundation for all subsequent preclinical development. Vectors with high purity and low endotoxin levels, produced in a well-documented manner, generate more reliable in vivo data. This reduces the risk of confounding variables in IND-enabling toxicology studies and provides a clearer path to defining the quality attributes required for an IMPD submission to the MHRA.

What are the key differences between adenoviral and lentiviral vectors for early ATMP development?

The choice depends on the therapeutic strategy. Adenoviral vectors are suited for high-transduction efficiency in a broad range of cell types and do not integrate into the host genome, a key consideration for certain safety profiles. Lentiviral vectors are optimal for applications requiring stable, long-term gene expression, such as ex vivo modification of cells for CAR-T therapies, due to their ability to integrate into the host genome.

Can Franklin Biolabs produce novel or engineered viral vectors for discovery-phase projects?

Yes. The scientific team, which transitioned from the Penn Vector Core, has extensive experience manufacturing both wild-type and engineered serotypes. This includes the production of novel and refractory capsids for AAV, as well as custom adenovirus and lentivirus constructs to support discovery and preclinical programs for next-generation therapies.

A stylized rendering of a DNA double helix on the left side of a light blue gradient background.

Aligning Vector Production with UK Regulatory Expectations

Developing an ATMP for the UK market requires a forward-thinking approach to vector production, even at the earliest research stages. The data generated from initial in vivo proof-of-concept studies directly informs the design of later, GxP-compliant toxicology programs required for an IMPD. The quality and characterization of the research vector is a strategic component of the regulatory pathway.

A core consideration for the MHRA is the long-term safety profile of any vector-based therapeutic. Concerns around vector persistence and potential for host genome interaction must be addressed with robust data. For non-integrating vectors like adenovirus, demonstrating a lack of persistence in non-target tissues is a powerful de-risking step. This principle is supported by historical clinical data where sensitive PCR assays confirmed the absence of adenoviral vector DNA in tumor tissue from subjects years after administration (PMID: 24010702), providing a valuable framework for safety assessments.

Purity, Immunogenicity, and Preclinical Outcomes

The innate immune response to viral vectors is another area of intense regulatory focus. The presence of process-related impurities or a high ratio of empty to full capsids can trigger unintended immunological cascades, confounding preclinical results. Research has shown that the innate immune system, including macrophages and NK cells, can react to adenoviral vector administration, influencing tissue response (PMID: 15714134).

Producing research-grade vectors with high purity minimizes these confounding immune responses. This ensures that the observed biological and toxicological effects in preclinical models are attributable to the therapeutic payload and capsid, not to manufacturing residuals. This clean data is invaluable for building a coherent narrative for MHRA review.

Our vector production services, part of a >100,000 sq ft facility, focus on delivering vectors with the following characteristics to support UK and global ATMP programs:

  • High Purity: Iodixanol gradient ultracentrifugation or chromatography purification methods are utilized to minimize process-related impurities.

  • Comprehensive QC: A suite of QC analytics is available to characterize vector identity, purity, and titer, providing a well-defined reagent for your studies.

  • Expanded Modalities: Production capabilities include Adenovirus and Lentivirus to support a wide range of therapeutic applications, from vaccines to ex vivo cell engineering for CAR-T programs.

By starting with a well-characterized, high-purity vector, ATMP sponsors can generate the unambiguous preclinical data needed to proceed with confidence toward IMPD and Clinical Trial Authorisation (CTA) submissions.

This strategic approach to early-stage vector manufacturing aligns with the 18-24 month timelines our core scientific leadership has historically achieved in getting candidates to IND. For more information on our vector services, please see our parent hub page: AAV Research Vector Packaging Services.

Scientific Process Diagram

This content is for informational purposes. For guidance specific to your therapeutic program, please contact our team for a consultation.

Explore More Capabilities