Proven Intelligence Accelerating Next-Generation Therapies.

Executive Summary

For sponsors developing advanced in vivo or ex vivo next-generation therapeutics, the purity of the lentiviral vector (LVV) is a primary determinant of program success. This asset details the manufacturing and analytical considerations for producing LVV with minimal process-related impurities that could impact transduction efficiency or the functional profile of target cells. We outline a production workflow designed for biological quiescence, informed by deep expertise in vector biology, and supported by our >100,000 sq ft facility designed to accelerate programs toward an 18-24 month IND timeline.

Purity Considerations for Lentiviral Vectors

The efficacy of many advanced therapeutics depends on precise genetic modification without unintended biological consequences. Residual impurities from the LVV manufacturing process, such as host cell proteins, DNA, or aggregates, can trigger unintended cellular responses or immunogenicity. This can lead to reduced transduction efficiency and diminished therapeutic function.

A manufacturing process must be designed for exceptional purity alongside yield. The objective is to deliver a final vector preparation that is biologically quiescent, ensuring the genetic payload is delivered without altering the baseline state of the target cells.

Manufacturing Informed by Vector Biology

Our approach to lentiviral vector production is directly informed by a comprehensive understanding of how viral vector components interact with biological systems. Experience across multiple vector platforms has established clear principles for purification processes that effectively remove immunogenic components.

Applying these principles, we focus on multi-step chromatographic purification and tangential flow filtration (TFF) to clear process-related impurities. This methodology results in a highly pure vector preparation suitable for sensitive in vivo and ex vivo applications.

Core Manufacturing & Analytical Capabilities

Our research vector production services provide a clear pathway from initial discovery to IND-enabling activities.

• Plasmid Production: In-house plasmid manufacturing capabilities ensure a secure and rapid supply of high-quality starting material.

• Upstream Processing: Transient transfection of suspension-adapted HEK293 cell lines for scalable vector production.

• Downstream Purification: Robust purification strategies using chromatography methods to achieve high purity and remove empty capsids and process contaminants.

• Analytical Release: A comprehensive panel of QC assays to characterize vector identity, purity, and concentration, providing the data needed to advance your program.

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 integral to our AAV-vector based gene therapy candidate development, and we hope to continue the partnership for years to come.
— Biotech Partner

From Research Grade to GxP Readiness

The team that has supported numerous global IND submissions, contributing to a 100% successful IND rate since 2019 for programs it has supported, now operates as Franklin Biolabs following our 2024 launch. We produce research-grade vectors with future clinical application in mind, ensuring the process is built on a foundation that can be translated into a GxP-compliant manufacturing environment. This continuity minimizes risk and accelerates the transition from preclinical research to clinical development.