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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 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, Oxford Biomedica 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.

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

  • Chart upward trend icon HIGH PERFORMANCE >1E15 vg/L bioreactor titer demonstrated across >10 serotypes and multiple genes of interest
  • Clock icon HIGH QUALITY >90% full AAV vector achieved
  • Wave chart icon ANALYTICAL DEVELOPMENT >45 methods developed for full vector characterization, quality control, and stability testing
  • Clipboard magnifying glass icon REGULATORY EXPERIENCE 6 successful IND/CTA submissions accepted
  • Box with shield icon COMMERCIAL READINESS optimized manufacturing process scaled to 500 & 2000L
  • Upward arrow icon 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 Oxford Biomedica, cross-functional means breaking through any potential silos. To accomplish this, we

  • Hands shaking icon Operate as one team, and leadership invests heavily in the organization-wide, cross-functional approach
  • People in circle icon Employ cross-functional teams working in tandem to explore the process and the analytical methodology in depth
  • Letter i on page icon Share technical information and understanding as natural parts of how we work

A Novel, High-Performing AAV Vector Production System

The Full Solution suite of services has the flexibility and adaptability to support both dual- and triple-plasmid systems.

Our suite of services is linearly scaled from 2 to 2000L

  • Wave chart icon We have run >1000 batches at various scales with 550+ constructs bearing different serotypes and genomes
  • Chart upward trend icon We have demonstrated bioreactor titers >1E15 vg/L, nearly 10X above the industry average, and achieved >90% full AAV product with our our suite of services
  • Geometric figure icon Our suite of services 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

  • Upward arrow icon 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
  • Light bulb icon CUTTING-EDGE TECHNOLOGY is the baseline at Oxford Biomedica. 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
  • Wave chart icon 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
  • People in circle icon DECADES OF COLLECTIVE COMMERCIAL EXPERTISE means that our team of experts is equipped to provide unparalleled AAV manufacturing and gene therapy solutions

Combined with our commitment to deliver

  • innovation
  • expertise
  • cross-functional teamwork

the consistent Oxford Biomedica approach is to identify what works best for each individual product and then execute to your expectations.