Cell and gene therapy services

Benefits of our cell and gene therapy services:

Automated, closed processes from the start: Automating early improves your program’s scalability, reduces variability, and makes your asset more attractive to investors and regulators.

Accelerated timelines through platform integration: Our modular platform and seamless product integration reduce complexity and speed up development, tech transfer, and manufacturing—bringing your therapy to patients faster.

Simplified clinical manufacturing: Benefit from flexible scheduling, agile capacity, and ballroom manufacturing—designed to adapt to your project needs and accelerate clinical readiness.

Program scope development

In this initial collaborative step, we capture current knowledge, collect batch records, analytical data, and prior reports. We then distill all the available information into a Quality Target Product Profile (QTPP), defining the intended clinical use, dosage form, and critical quality attributes. We identify gaps and risks by conducting a formal gap analysis and risk assessment (FMEA/ICH Q9) to surface missing data, high‑risk assays, and process uncertainties.

Based on this, we develop the product development plan, which provides the roadmap outlining the chronological approach of activities recommended for completion based on your pre-clinical and clinical strategy and timeline.
We use standardized tools, predetermined processes, dedicated platforms, and qualified materials, which put you on the path to an IND in months, not years.

Knowledge transfer & assay development

Robust analytics sit at the heart of every CGT program. Immediately after the scoping phase, we define the Analytical Target Profile (ATP) in line with ICH Q14/USP <1220>, linking each critical quality attribute to fit‑for‑purpose acceptance criteria. We then transfer existing methods and close gaps by reviewing source SOPs, running side‑by‑side transfer lots, and refining methods as needed to meet the ATP. Accelerate your path with our platform

assays drawn from our validated library of potency, identity, purity, and safety tests already in routine use across our cGMP cell‑processing sites.
The result is phase-appropriate method qualification and documentation ready for inclusion in your IND in weeks, not months.*

^{*Timelines assume platform methods and availability of reference materials; novel assays may require additional development and validation.}

Process development

Our process development team will use the Process Development Plan as a roadmap to optimize, automate, and close your process. Clients can leverage existing standard platform processes or opt for greater flexibility on the CliniMACS Prodigy®, such as through custom application development and closed

integration with complementary adherent or larger-scale cell culture devices.

Process and Assay Transfer to cGMP

From day one, our MSAT and ASAT teams work as a single unit to carry your process and its critical assays from development bench to cGMP floor. We begin with a joint transfer package, consisting of consolidated process descriptions, analytical methods, raw-material specifications, and risk assessments prepared for rapid onboarding. Next, we prepare cGMP documentation and training, drafting MBRs, SOPs, and assay transfer reports, and then conduct training for operators and QC staff. This is followed by side-by-side engineering runs, where

MSAT optimizes unit operations while ASAT performs method bridging, qualification, and comparability studies. Throughout the process, we maintain a feedback loop, ensuring continuous data sharing between MSAT, ASAT, and your team to refine parameters, address deviations, and align with evolving clinical or commercial targets. Our deliverables include qualified equipment and methods, completed tech-transfer reports, a phase-appropriate validation plan, and a clear path to PPQ and commercial launch.

Clinical manufacturing

Timelines are tight, pressure is high, and patient recruitment is difficult. In manufacturing, we aim to be flexible, streamlined, quality minded, and cost effective. Our ballroom manufacturing model allows for favorable pricing, and flexible scheduling models.

We work with you through any unforeseen roadblocks, and make sure that manufacturing is never your bottleneck.

Commercialization

Across our global network of three ready-made, CliniMACS Prodigy-equipped CliniMACS Cell Factory® suites, we have the capacity to produce over 5,000 cell therapy batches per year. We operate with a commercial-ready quality system and three commercial-ready cell therapy manufacturing sites. Our team of experts will guide you through

process characterization and validation, leveraging a closed and automated manufacturing paradigm to simplify program scale-up and site-to-site technology transfer. With our robust infrastructure and expertise, we are fully equipped to scale your program.

Key features of our cell and gene therapy platforms

Proven performance across most relevant cell types and gene editing approaches

Strong track record for autologous and allogeneic applications

Dedicated project manager to allow one point of contact throughout lifecycle of engagement

Process platforms for rapid development to IND timeline

Repeatable, reproducible process on a closed, automated manufacturing platform

Holistic suite of analytics to enable all in-house QC testing

Flexible clinical manufacturing scheduling and favorable terms

Manufacturing in a ballroom environment with easily viewable production

Our cell and gene therapy services

Proof of excellence

95% cGMP batch
success rate*

Over 750 cGMP cell therapy batches released

100% on-time delivery of
cGMP batches*

Benefits of our cell and gene therapy services:

Get to clinical trials in as little as 9 months*