For UK-based therapeutic developers, advancing an AAV program toward Investigational Medicinal Product Dossier (IMPD) submission requires a manufacturing strategy that ensures both scalability and batch-to-batch consistency. Suspension-based AAV production provides a robust framework for generating the high-quality, high-titer vector required for comprehensive IND-enabling toxicology studies. This approach directly addresses the manufacturing challenges that can introduce variability and delay timelines, supporting an 18-24 month path to IND by generating material suitable for rigorous evaluation by the MHRA. Franklin Biolabs’ process, executed within our >100,000 sq ft facility, is built upon the foundational expertise that has achieved a 100% successful IND rate since 2019 for programs led by our core scientific team, which transitioned to the Franklin Biolabs brand upon its formal launch in 2024.

AAV Scalable Suspension: Engineering Consistency for UK Preclinical Programs

Proven Intelligence in Preclinical Vector Manufacturing

Generating sufficient vector for a preclinical program is a foundational step toward a successful IMPD submission. The manufacturing process itself is a significant variable that can influence vector quality, potency, and immunogenicity. A well-controlled, scalable suspension culture process is designed to mitigate these risks, ensuring that the material used in pivotal toxicology studies is representative of the final clinical product.

The transition from small-scale research production to generating hundreds of milligrams of vector requires a manufacturing platform built for consistency. Our approach utilizes single-use bioreactors to create a controlled environment that supports high-density cell growth and efficient vector production, directly supporting accelerated timelines.

“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 provides the essential manufacturing expertise for our AAV-vector based gene therapy candidate development, and we hope to continue the collaboration for years to come.”
– Biotech Partner

Process Control and its Impact on Vector Biology

The consistency of a manufacturing process has direct biological consequences. Controlling production parameters is fundamental to managing a vector’s immunogenic profile, as variability can influence host immune responses and confound the interpretation of safety data (PMID: 17979679). A stable suspension process is designed to minimize this variability.

This level of control is also vital when working with highly engineered vectors. For next-generation therapies targeting the central nervous system, capsids like AAV-PHP.B have demonstrated enhanced transport across the blood-brain barrier (PMID: 30819613). Realizing the full potential of such capsids in preclinical models requires a manufacturing platform capable of producing them at high concentration and purity, without compromising their unique biological activity.