Cross-cutting specialism

Cell and gene therapy

CMC rigour for advanced therapies, without losing speed: autologous or allogeneic, viral vector or non-viral.

Discuss your programme

Overview

In cell and gene therapy the process is the product. Small changes in starting material, vector quality or hold times can alter potency and safety, and the patient may be waiting for the batch.

We bring experience of manufacturing, analytics and regulation together so your programme can move quickly without opening questions you cannot answer.

What we do

Vectors and starting materials

Strategy for lentiviral, AAV and plasmid supply, and qualification of critical raw materials and donor material.

Cell therapy processes

CAR-T, TCR, NK and stem cell workflows, including the move from manual to closed and automated platforms.

Potency and release testing

Assay strategy, qualification and the case linking potency to clinical response.

Chain of identity and logistics

Vein-to-vein planning, cryopreservation, shipping validation and patient scheduling.

Comparability

Studies that show a changed process still makes the same product, for programmes with small batch numbers and limited material.

Regulatory pathways

ATMP classification, expedited designations such as RMAT and PRIME, and alignment with FDA guidance and EU GMP Part IV.

When teams call us

  • You are moving from an academic or research process to GMP.
  • You are automating a manual process and need to show comparability.
  • Vector supply or potency assays are the bottleneck.
  • You are planning a pivotal trial and need a commercial-ready process.

How it runs

  1. Understand the product

    We map the process, critical quality attributes and the risks specific to your modality.

  2. Fix the bottleneck

    We focus first on the issue that limits your timeline, whether vector, assay or capacity.

  3. Build the package

    We assemble the data, documents and systems the next phase requires.

  4. Prepare to scale

    We plan the move to pivotal and commercial supply, including sites and logistics.

Common questions

Yes. The risks differ, particularly around scheduling, chain of identity and batch size, and we plan for them accordingly.

Yes. A common first step is a gap assessment that shows what is needed to reach a GMP-ready process and the likely order of work.

Yes. We cover the CMC aspects, including editing reagents, off-target and characterisation strategies, in coordination with your non-clinical team.

Related services

CMC strategy and regulatory support

Development to filing

Technology transfer

Sponsor to CDMO, site to site

Clinical and commercial manufacturing

Phase 1 through launch

Tell us what you are facing

A thirty-minute scoping call, no charge. We will tell you honestly whether we are the right team.

Book a call