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The Full Solution Enables End-to-End AAV Vector Production

Oxford Biomedica is a development partner offering comprehensive, fully integrated cell and gene therapy services that can support you at any stage of development. Our robust processes mean that whether we help you design the construct or you bring a construct to us, the outcome will be high-yield, high-quality product.

Our manufacturing processes are designed to accelerate timelines and to support all phases, from earliest development through clinical and commercial manufacturing.

AAV Construct and Plasmid Design

Oxford Biomedica offers expert end-to-end construct and plasmid design services that can start from the simple identification of your gene of interest (GOI).

From this point, we partner with you to develop your GOI into a fully optimized AAV vector, helping you select the

  • Broken link icon AAV PAYLOAD SEQUENCE
  • Dashed line icon STABLE INVERTED TERMINAL REPEATS (ITRs)
  • Dashed line icon PROMOTER AND OTHER REGULATORY ELEMENTS
  • Geometric shape icon AAV SEROTYPE AND CAPSID VARIANT
  • Overlapping circles icon OXFORD BIOMEDICA DUAL-PLASMID SYSTEM

to create the construct that will best suit your desired application.

Our team will then design and perform manufacturability assessments, providing you with full support and documentation to rapidly move your project to the next level.

Our design process is built to systematically identify and address any potential concerns at the earliest possible point, across a range of product requirements. We get it right the first time.

Analytical Method Development

Our strong analytical core plays a central role at Oxford Biomedica. We can perform more than 45 analytical methods—including next-generation sequencing and mass spectrometry—for

  • Wave chart icon biophysical characterization
  • DNA icon biological activity
  • Magnifying glass icon impurity monitoring
  • Checkmark icon control

These methods can be used for full AAV vector characterization, quality control, and stability testing. Click below to see a recent poster presentation on our vector characterization process.

Process Development

To ensure ideal manufacturing conditions, our process development team rigorously evaluates numerous factors, including

  • Arrow on circle icon UPSTREAM PROCESSES such as plasmid and construct design, cell culture, transfection, and vector harvest
  • Scientific equipment icon DOWNSTREAM PROCESSES such as vector purification and concentration
  • Line chart with checkmark icon ANALYTICAL METHODS
  • Test tube icon FORMULATION

CGMP Manufacturing

We are fully Good Manufacturing Practices (CGMP) compliant, providing consistent, high-yield AAV gene therapy product that can be readily scaled to commercial levels while also meeting rigorous safety, efficacy, and stability requirements.

AAV cGMP manufacturing facility scientists

QA Release

Our quality team performs a detailed quality assurance (QA) release evaluation for every batch, including analytical testing and production records review, to ensure that your product achieves regulatory success.

Our process adheres to the most stringent regulatory guidelines, so that drug quality is not a concern when it comes time to test your product in the clinic.

Geometric shapes rendering

Stability Support

Our analytics and quality teams routinely test and document product stability to assess product readiness for use in clinical applications.

  • Vial icon Dedicated stability team manages all GMP stability testing
  • Geometric shape icon We can develop GMP stability studies for cell banks, drug substance, and drug product
  • Clipboard with magnifying glass icon Continuously monitored stability chambers support -80 °C, 2 to 8 °C, and 23 to 27 °C (at 60% relative humidity) routinely and can support additional stability storage requirements as needed
  • Wave chart icon We can help design ICH-compliant stability studies, assist with stability data evaluation, and support shelf-life determination
Two vials

CMC Support

Our extensive chemistry, manufacturing, and controls (CMC) support capabilities benefit from the technical expertise of our program management leads. Our CMC expertise includes preparing and filing regulatory submissions for commercial authorization. Our cell and gene therapy service experts have the experience and acumen to direct cross-functional teams to ensure they deliver to the highest standards throughout our CMC drug development.

Chemical manufacturing control technician for cell and gene therapy services

Technical and Process Development

Excelling at Technical and Process Development in AAV Gene Therapy

At Oxford Biomedica, we understand that careful research and thoughtful product development are the building blocks for effective and efficient product manufacturing.

That’s why our process development group features a team fully dedicated to AAV gene therapy construct design, process development, analytical development, and formulation development.

Our industry-leading development teams recognize their central role in pursuing groundbreaking innovations, and they are committed to continuing this organizational imperative.

As one example of our innovative R&D, we have produced a formulation that keeps AAV vectors stable at 2-8 °C for (at least) 12 months.*,† *NOTE: Based on 12-month testing parameters. Stability may be longer.
Patent pending.

Analytics

Analytics Underpin Cell and Gene Therapy Services

Advanced analytics at Oxford Biomedica include a comprehensive suite of more than 45 in-house methods that can be leveraged and used for biophysical and biochemical characterization, biological activity, impurity, quality control, and other types of essential monitoring. Process, analytics, manufacturing, and QC teams openly share data, and cross-functional teams work to maximize the value of every output.

Our sophisticated analytics have helped optimize dual- and triple- plasmid system integration have enabled maximization of our AAV gene therapy titers and quality

Our robust back-end analytics mean reliably accurate vector characterization

GMP Practices

AAV Vector Production and GMP

At Oxford Biomedica, we provide consistent, pure, high-yield products while being fully compliant with GMP.

The Full Solution suite of services routinely delivers stable, purified, commercially viable amounts of GMP viral vectors at the 500L scale and will scale up to 2000L.

We are a multiproduct GMP manufacturing facility, so our cell and gene therapy services have the capacity to simultaneously implement multiple projects.

The innovative, proprietary processes implemented at Oxford Biomedica are designed to support quality in all phases of clinical and commercial manufacturing, including

  • Circle icon plasmid and construct development
  • Cell bank icon cell bank
  • Geometric shape icon vector production
  • Wave chart icon process and formulation development
  • Clipboard with magnifying glass icon analytical development
  • Vial icon full GMP drug substance and product manufacturing

Quality and Regulatory Support

Quality and Regulatory Support for Our Cell and Gene Therapy Services

A key priority at Oxford Biomedica is maintaining the highest product quality. Our commitment to quality shows its value through our delivery of quality products to patients.

Our successful navigation of several regulatory filings is a direct result of quality being a day-to-day imperative that permeates through the whole organization.

We work closely with our partners to enable successful regulatory approval.

The experience and expertise that we bring will guide you to ensure a smooth process. We will partner with you to develop strategies to mitigate risk to your program and ensure constructive relationships with regulatory authorities.

Quality Policy

Oxford Biomedica is committed to the manufacture and delivery of innovative, high-quality cell and gene therapy products. We maintain a culture of quality that is integrated throughout our operations. The Quality Management System provides the framework for consistent execution in accordance with regulatory requirements. Our performance is routinely monitored to drive continuous improvement in our relentless pursuit of delivering life-saving medicines.

In each case, we work hard to uncover the answers to your questions well in advance, to minimize challenges as product development moves forward.