Proven Intelligence Accelerating Next-Generation Therapies.

Executive Summary

Inconsistent research-grade viral vectors generate unreliable data, compromising the integrity of early discovery and preclinical programs. This variability introduces significant risk, leading to delays and complicating the path to a successful Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) submission. Franklin Biolabs mitigates this risk through a platform approach to AAV, lentivirus, and adenovirus vector production, combining standardized plasmid services with a robust suite of analytical assays to ensure high lot-to-lot consistency. This methodology provides a reliable foundation for programs targeting an 18-24 month timeline to IND.

The Foundational Risk of Vector Inconsistency

Variability between research vector batches is a common point of failure in early therapeutic development. When each vector lot behaves differently, establishing a clear dose-response relationship or accurately assessing biodistribution becomes exceptionally difficult. This forces research teams to repeat experiments, consuming valuable time and resources while delaying program decisions.

The molecular structure of the vector genome itself can be a source of heterogeneity. Post-transduction analysis has shown that vector genome structures can differ significantly, which may influence the persistence and level of transgene expression (PMID: 20113166). Without rigorous analytical controls during production, these molecular differences between lots can obscure the true performance of a therapeutic candidate.

A Platform Approach to Predictable Vector Supply

A standardized production process is the most effective way to minimize lot-to-lot variation. Our approach begins with stringent quality control of all starting materials, including plasmid DNA production and verification. We utilize established, scalable suspension and adherent platforms for AAV, lentivirus, and adenovirus production, which provides a consistent manufacturing environment from small research batches to larger preclinical lots.

This process control is paired with a deep understanding of vector biology. The choice of AAV serotype, for instance, directly influences gene transfer efficiency and tissue-level outcomes, requiring a production process that reliably preserves capsid integrity (PMID: 22849678). By maintaining consistency, we ensure that the vector used in early discovery performs predictably in subsequent IND-enabling toxicology studies.

Decades of Vector Production Experience

Our scientific leadership team has a long history of providing viral vectors to the global research community. This expertise, built on capsid technology that has supported numerous clinical-stage programs, forms the operational backbone of Franklin Biolabs. While the Franklin Biolabs brand launched in 2024, our team’s work has contributed to a 100% successful IND rate for programs we have supported since 2019.

“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 a key collaborator in our AAV-vector based gene therapy candidate development and we hope to continue the partnership for years to come.”
— Biotech Partner

This continuity ensures that every research vector project benefits from decades of institutional knowledge in overcoming common production and analytical challenges. Our work is conducted within a >100,000 sq ft facility purpose-built for preclinical and bioanalytical programs.