Research Vector Production for Preclinical Programs

High-quality research-grade vectors are a prerequisite for generating translatable data for advanced therapeutics and complex biologics. Applying proven intelligence in early-stage vector production accelerates candidate selection and de-risks the subsequent path to IND submission. The utility of early nonclinical models depends entirely on the quality of the vectors used to generate initial proof-of-concept data.

A tailored preclinical strategy requires vectors that are well-characterized and produced with scalable methods in mind. This foresight prevents costly redevelopment and analytical bridging studies later in the program. Our approach focuses on producing vectors suitable for rigorous preclinical evaluation, including early safety and efficacy assessments in relevant animal models and suitable for scale up production for clinical production.

AAV Vector Production

We produce a comprehensive range of adeno-associated virus serotypes and engineered capsids for preclinical research. This includes clinically validated capsids such as AAV8 and AAV9, alongside novel variants designed for specific tissue tropism. Insights from preclinical safety evaluations, such as those identifying potential toxicities associated with high-concentration systemic AAV administration (PMID: 38327046), inform our consultative approach to capsid selection and study design.

• Plasmid Services: Custom plasmid design, optimization, and research-grade plasmid DNA production to support vector manufacturing.
• Production Platforms: Established adherent and suspension-based production systems, providing a direct line of sight to scalable GMP manufacturing from 2L to 200L+.
• Purification: Robust purification processes utilizing chromatography techniques to achieve high purity and yield.

Lentivirus and Adenovirus Vectors

Beyond AAV, our capabilities extend to other viral vector systems used in advanced therapy research. We produce high-titer lentiviral vectors for stable cell line generation and ex vivo cell modification. We also support research using high-capacity helper-dependent adenoviral platforms for applications requiring large transgene cassettes.

Integrated Analytical Characterization

Every research vector batch is released with a comprehensive analytical data package. This ensures that the material used in foundational preclinical studies is thoroughly characterized, providing confidence in the resulting data.

Phase-appropriate analytical services include:

• Vector Genome Titer (qPCR/ddPCR)
• Capsid Titer (ELISA)
• Purity Assessment (SDS-PAGE)
• Aggregate Analysis (DLS)

• Endotoxin Levels

• 18 additional assays spanning multiple aspects of vector quality.

This analytical rigor provides a solid foundation for subsequent IND-enabling toxicology studies and CMC development, ensuring a smoother transition from research to clinical development.