Cell & Gene Therapy

Cell and Gene Therapy (CGT) represents a transformative shift in medicine, moving beyond symptom management toward potential cures at the genetic level. Because the final product is a living cell, bioprocessing demands exceptionally robust, closed, and automated workflows to maintain functional potency from the point of harvest to patient infusion. We help our customers enhance process development, achieve process intensification, and establish robust technical frameworks to support cGMP-compliant manufacturing.

Cell and Gene Therapy: Potency from Harvest to Patient

Characterisation & Phenotyping

The process begins with the rigorous characterisation of cell populations to meet the precise quality and purity requirements mandated by regulatory bodies, including the FDA and MHRA.

Automated Imaging: We integrate SYNENTEC systems, such as the NYONE and CELLAVISTA, which are essential for high-throughput phenotyping and definitive clonality assessment for allogeneic therapies.
Selection & Expansion: These systems ensure that only the desired cell populations are progressed, de-risking the expansion phase from the outset.

Maintaining the Sterile Boundary

In CGT, protecting high-value products from contamination is critical. We focus on creating closed environments that reduce risk and accelerate the manufacturing cycle.

Custom Single-Use Assemblies: In collaboration with High Purity New England (HPNE) and through HPConnexx, we provide bespoke single-use solutions for the entire workflow - from initial inoculation and sterile fluid transfer to sampling and final formulation.
Operational Security: These closed systems eliminate the need for extensive cleaning validation, ensuring a more secure and rapid production turnaround. We can provide low numbers of fully customised single-use assemblies, ensuring you have exactly what your process demands.

Harvesting, Washing & Concentration

Particularly within allogeneic therapy workflows, maintaining the viability of sensitive cell types like iPSCs and mesenchymal stem cells (MSCs) is essential for therapeutic efficacy. Traditional separation methods often subject delicate cells to extreme physical stress, risking product quality.

Low-Shear Processing: We provide the UniFuge range from Carr Biosystems. Utilising a closed, automated tubular bowl design, the UniFuge enables cell gentle washing and concentration without the mechanical stress of traditional methods.
High Viability Recovery: This low-shear technology is vital for ensuring that recovery rates remain high (exceeding 90%), protecting the functional integrity of the cells and delivering a consistent starting point for downstream formulation.

Cryopreservation & Final Recovery

The final, critical step in the manufacturing chain is ensuring the medicine remains viable for the patient upon delivery. Protecting the structural integrity of these sensitive cells during storage is the ultimate hurdle before patient infusion.

Controlled-Rate Freezing: We offer SY-LAB freezers, which use precise freezing curves to protect cells through the phase transition from liquid to solid.
Maximising Post-Thaw Success: By minimising the formation of damaging intracellular ice crystals, these systems maximise post-thaw recovery - a crucial factor given the patient-specific nature of many therapies.

Areas we work in

Why Partner with us?

We don't just supply equipment; we understand that in Cell and Gene Therapy, the ‘process is the product.’ By integrating automated, closed-loop technologies from SYNENTEC, HPNE, Carr Biosystems, and SY-LAB, we help you maintain the highest standards of potency and purity throughout the therapeutic journey.