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 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.
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.
Oxford Biomedica is continuing to innovate on The Full Solution™ suite of services, 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.
*Patents pending.
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
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HIGH PERFORMANCE
>1E15 vg/L
bioreactor titer demonstrated across >10 serotypes and multiple genes of interest
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HIGH QUALITY
>90%
full AAV vector achieved
-
ANALYTICAL DEVELOPMENT
>45 methods
developed for full vector characterization, quality control, and stability testing
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REGULATORY EXPERIENCE
6 successful IND/CTA
submissions accepted
-
COMMERCIAL READINESS
optimized manufacturing 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 Oxford Biomedica, cross-functional means breaking through any potential silos. To accomplish this, we
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Operate as one team, and leadership invests heavily in the organization-wide, cross-functional approach
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Employ cross-functional teams working in tandem to explore the process and the analytical methodology in depth
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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
-
We have run
>1000 batches
at various scales with 550+ constructs bearing different serotypes and genomes
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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
-
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
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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 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
-
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
Our Approach Is Making a Difference
Starting with The Full Solution™ suite of services through
all the way to clinical use and full commercialization—
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.
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