Our Services

Process Development

Accelerating process development for cell and gene therapies. Our expertise ensures scalable, regulatory-ready processes, supporting seamless technology transfer into GMP manufacturing.

Optimising Process Development for Scalable and Compliant Manufacturing

Early-stage process development is essential for ensuring that cell and gene therapy (CGT) products are scalable, GMP-compliant, and commercially viable. Without a well-structured approach, companies face regulatory hurdles, manufacturing inefficiencies, and increased costs that can delay product development and market entry.

We provide phase-appropriate process development tailored to cell therapies, viral vectors, and RNA-based therapies. With over eight years of dedicated process development experience and a team that brings together decades of cumulative expertise, we have successfully translated both early- and late-stage programs into scalable, GMP-ready processes.

Our 6,400ft² laboratories house advanced equipment and industry-leading specialists, supporting process optimisation, scale-up, and seamless technology transfer into GMP manufacturing. We work closely with our clients to develop efficient, robust processes that align with regulatory expectations and commercial goals.

Our Process Development Capabilities

Our team specialises in developing, optimising, and scaling CGT manufacturing processes, offering:

Customised Process Development

Tailored programs for early-stage feasibility, scale-up, and late-stage commercial readiness.

Integrated Analytical Services

Supporting process optimisation with genetic, protein, and cell-based assays.

Scalability Assessment

Ensuring processes transition smoothly from lab-scale to GMP production.

Technology Transfer Expertise

Seamless transfer of processes into our GMP facility or external CDMOs.

Our Process Development Services

Cell Therapy

Our cell therapy process development team supports both autologous and allogeneic therapies, ensuring robust, scalable, and regulatory-ready processes. We have experience in iPSCs, MSCs, and immune cells, with expertise across 2D and 3D culture systems, bioreactor-based expansion, and cryopreservation strategies. Our team helps clients transition from lab-scale research to GMP manufacturing, ensuring process consistency and quality at every stage.

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Vector

Developing AAV and lentivirus processes presents unique challenges in yield, purity, and scalability. Our viral vector team offers custom development programs, optimising key steps such as transfection, enrichment, and formulation. We provide scalable suspension and adherent processes, ensuring efficient vector production with a focus on cost-of-goods optimisation and regulatory compliance.

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RNA

RNA-based therapies, including mRNA, saRNA, and cRNA, require highly controlled, reproducible processes. Our expertise covers in vitro transcription (IVT), purification, lipid nanoparticle (LNP) encapsulation, and fill-finish. We offer a phase-appropriate development platform, enabling rapid process optimisation while ensuring smooth transition to GMP manufacturing.

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Why Partner with Us?

Expertise in Process Scale-Up

Applying robust engineering parameters and deep knowledge of GMP manufacturing to ensure processes are scalable, reproducible, and commercially viable.

Regulatory Foresight

Supporting early Quality Target Product Profile (QTPP) development, GMP risk assessments, and cost-of-goods (CoG) studies, helping to define key drivers for a phase-appropriate process development program.

Flexible Use of Platform Processes

Where appropriate, leveraging non-proprietary platform processes to accelerate early-stage development and generate pre-clinical material for non-human studies, while maintaining full client control over IP.

Seamless Scale-Up Strategies

Expertise in bioreactor selection, process intensification, and closed-system adoption, enabling smooth transition from lab-scale development to GMP manufacturing.

Integrated Analytical Support

In-house analytical services for process characterisation, comparability, and real-time monitoring, ensuring data-driven decision-making at every stage.

Optimise and Scale Your Therapy with Expert Process Development

From early feasibility to GMP readiness, we develop scalable, regulatory-ready processes for cell therapy, viral vectors, and RNA-based products. Contact us today to discuss how we can accelerate your path to GMP manufacturing.