Process Development

Cell Therapy

Optimising and scaling cell therapy manufacturing. Our expertise ensures robust, regulatory-compliant processes for autologous and allogeneic therapies.

Advancing Cell Therapy Manufacturing with Scalable, GMP-Ready Processes

Cell therapy manufacturing presents unique challenges, including process variability, scale-up complexities, and regulatory compliance. Without a structured development approach, companies risk inconsistent product quality, manufacturing inefficiencies, and regulatory hurdles.

We develop scalable, well-controlled cell therapy processes, ensuring they are GMP-compliant and commercially viable. Our expertise spans iPSCs, MSCs, and immune cells, with experience across 2D and 3D culture systems, bioreactor-based expansion, and cryopreservation strategies. We work closely with clients to de-risk scale-up and accelerate technology transfer into GMP manufacturing.

Our Process

Stem Cell Culture

Expertise in adherent systems (T-flask to HYPERStack/CellSTACK) and suspension culture, including adherent-to-suspension transition.

Suspension Platforms

Small-scale (125 mL spinner flasks, Biott, Vertical Wheel), Ambr250 for optimisation, and large-scale (BioBlu for 1–50 L cultures).

Immune Cell Expansion

Use of G-rex (Wilson Wolf) and CliniMACS Prodigy (Miltenyi) to expand a range of immune cell types isolated from Leukopak.

In-Process Analytics

Includes cell viability (Chemometec), metabolite analysis (Cedex, Roche), and real-time bioreactor monitoring (Ambr250, Eppendorf BioBlu).

Time Point Analytics

Conducted with support from our analytical services team, offering rapid turnaround for Flow Cytometry, qPCR/ddPCR, HPLC, ELISA, and more.

Process Optimisation & Scale-Up

Experience in 2D to 3D translation of MSCs and iPSCs, including microcarrier screening, media optimisation, and suspension parameter studies.

Integrated Expertise Across Teams

Collaboration with CMC consulting, Quality, Capital Projects, and GMP teams to ensure project success at every stage.

Technology Transfer & GMP Support

Our process development team supports all GMP projects during technology transfer and provides specialist SME expertise throughout manufacturing.

Key People

Adam Janvier

Head of Cell Therapy

Evelien Stalmeijer

Chief Cell & Gene Therapy Consultant

David Vincent

Head of Process Development

Why Partner With Us?

Specialist Expertise in Cell Therapy Scale-Up

Decades of experience in optimising autologous and allogeneic cell therapy processes, translating small-scale research to production-scale GMP manufacturing.

Tailored Bioprocess Development

Expertise in 2D and 3D culture systems, including adherent-to-suspension transition, microcarrier screening, and process intensification.

Integrated Analytical & Process Monitoring

In-house support for real-time bioreactor monitoring, metabolite analysis, and cell viability tracking, ensuring high reproducibility.

Advance Your Cell Therapy with Expert Process Development

From early-stage optimisation to GMP readiness, we develop scalable, compliance-focused cell therapy processes. Contact us today to discuss how we can accelerate your path to GMP manufacturing.

Request a Proposal

Other Process Development Services

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.

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.