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Quality services for cell and gene therapy
At OXB, quality is the foundation of every process, decision and partnership. Built into every stage of viral vector development and manufacturing, it is a strategic discipline that shapes process design, analytical readiness, regulatory confidence, and the ability to move from development to reliable supply.
Our approach to quality services
As a global, quality and innovation-led viral vector CDMO, we embed quality throughout the product lifecycle, helping ensure processes, analytical methods and manufacturing operations are developed with scalability, consistency and regulatory expectations in mind.
From process and analytical development through GMP manufacturing and commercial supply, our teams apply a science and risk-based approach to quality. By establishing process understanding early, maintaining robust analytical control strategies and embedding quality oversight throughout development, we help generate the data and knowledge required to support informed decision-making and future scale-up.
Quality systems that support execution
Our integrated Quality Management System provides oversight across development, manufacturing, testing and supply, supporting compliance with global regulatory requirements.
Through structured quality processes, including risk management, change control, deviation management, CAPA and supplier oversight, we help ensure quality is proactively managed throughout the product lifecycle.
Why choose OXB for quality services?
Our global quality standards drive and support:
Accelerated programme progression
Consistent product quality
Seamless technology transfer
Quality as a strategic advantage
Quality is more than a compliance requirement - it is a critical enabler of successful development and manufacturing. It helps establish the foundations needed to support clinical progression and future commercialisation, and provides the controls, oversight and process understanding required to manage complexity, reduce risk and support reliable delivery at scale.
By embedding quality from the earliest stages of development, we help clients build robust, scalable programmes that are designed for long-term success.
This approach is designed to give clients practical confidence at each stage: clearer development decisions, stronger readiness for regulatory interactions, more controlled technology transfer and a more reliable path toward GMP manufacturing and commercial supply.
A culture built on accountability, collaboration and continuous improvement
At OXB, quality is reflected in the way our teams work, make decisions and collaborate with clients.
Our quality, development, analytical and manufacturing teams operate within a unified framework, ensuring quality considerations are integrated into every stage of a programme. This cross-functional approach helps strengthen process understanding, accelerate problem-solving and support consistent execution.
Partner with OXB for quality excellence
Whether you’re preparing your first IND or managing commercial supply, OXB’s integrated quality and regulatory services provide confidence, compliance, and speed to market.
Explore OXB’s other CDMO solutions
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