OXB Solutions AAV manufacturing company facility

How We Deliver

Achieving Leadership in AAV Manufacturing

We are committed to adeno-associated virus (AAV) and to the patients that ultimately benefit from our work. Delivering on this value is important to the entire Oxford Biomedica Solutions team.

Everything we do and how we do it comes from our commitment to our partners and their patients.

Emphasizing Continuous Innovation

01.

To gain and maintain leadership in the AAV development field, OXB Solutions is passionate about continuous learning and innovation.

02.

Each member of the team is constantly looking for creative ways to improve and innovate every process.

03.

We are continually learning and expanding our knowledge so that we never stop innovating.

This is our approach to AAV manufacturing.

We know this is the only way to ensure we are delivering the highest product quality and efficacy to your patients– and to ensure we’re always ready for the next challenge.

We’re always ready for the next challenge.

How ready?

01.

We have made improvements to our plasmid-transfection process to increase the bioreactor titer yields 10X above industry average.

How ready?

02.

OXB Solutions is continuing to innovate on its platform technology, with plans to incorporate novel methods, such as optimized plasmid design and improved separation technology, to increase efficiencies that facilitate even greater vector genome productivity.

How ready?

01.+02.

Those are just two examples of how we consistently strive to stay ahead of the learning curve.

Deep Technical Expertise in AAV Vectors and Beyond

Our team features the extensive technical know-how and deep expertise needed to fully understand the challenges of AAV manufacturing. Our strong quality culture permeates the entire organization and demands that we achieve at the highest level through all functions.

Because of our expertise, continued pursuit of innovation, and our team members’ accomplished backgrounds, we are able to offer

HIGH PERFORMANCE >1E15 vg/L bioreactor titer demonstrated across >10 serotypes and multiple genes of interest
HIGH QUALITY >90% full AAV vector achieved
ANALYTICAL DEVELOPMENT >45 methods developed for full vector characterization, quality control, and stability testing
REGULATORY EXPERIENCE 6 successful IND/CTA submissions accepted
COMMERCIAL READINESS optimized platform process scaled to 500 & 2000L
YIELD >1E17 vg of drug substance from 500L batches

Cross-Functional Implementation

Our talented, technically focused, and thoroughly trained Program Leaders know all the ins and outs of end-to-end product development. They drive cross-functional teams with a mastery that will produce your cell and gene therapy product—as specified and with excellence.

At OXB Solutions, cross-functional means breaking through any potential silos. To accomplish this, we

Operate as one team, and leadership invests heavily in the organization-wide, cross-functional approach
Employ cross-functional teams working in tandem to explore the process and the analytical methodology in depth
Share technical information and understanding as natural parts of how we work

A Novel, High-Performing AAV Vector Platform

Our proprietary platform has the flexibility and adaptability to support both dual- and triple-plasmid systems.

The platform is linearly scaled from 2 to 2000L

We have run >1000 batches at various scales with 550+ constructs bearing different serotypes and genomes
We have demonstrated bioreactor titers >1E15 vg/L, nearly 10X above the industry average, and achieved >90% full AAV product with our platform
Our platform is producing 10X vector with >1E17 vg of drug substance per 500L batch

have helped optimize dual- and triple-plasmid system integration, offering the flexibility to tailor our platform process to your specific needs.

has consistently demonstrated the highest performance and product quality.

Creating Commercial Efficiencies

SCALABLE MANUFACTURING is crucial to clinical and commercial success. We have consistently and successfully scaled up our process while maintaining our industry-leading high titers and full AAV vector purity
CUTTING-EDGE TECHNOLOGY is the baseline at OXB Solutions. Our proprietary technology is designed to optimize performance, quality, and flexibility. We constantly strive to be at the forefront of AAV manufacturing by finding ways to improve our methodologies and remain ahead of the curve
OUR PROPRIETARY PURIFICATION PROCESS is exceptionally adept at separating empty and full capsids. We have demonstrated a consistently high rate of isolation of full capsids, achieving >90% full AAV vector at commercial scales
DECADES OF COLLECTIVE COMMERCIAL EXPERTISE means that our team of experts is equipped to provide unparalleled AAV manufacturing and gene therapy solutions