Process Development & cGMP Manufacturing for Advanced Therapies
Advanced therapies, including cell therapy, gene therapy, extracellular vesicles, and more, offer life-changing potential. But turning breakthrough science into scalable, clinically viable treatments is challenging—requiring advanced technologies and deep process expertise to overcome process variability, complex regulatory demands, high costs, and long development cycles.
At Sartorius, we address these needs with process development and GMP clinical manufacturing services—designed to reduce the complexity and risk of your ATMP production. Our team of scientists design scalable, regulatory-ready processes backed by proven materials, innovative technologies, and deep technical expertise. The result? Shorter development cycles, high-quality outcomes, and future-ready lower cost manufacturing of groundbreaking treatments for patients.
Jumpstart Your ATMP Development & Manufacturing With:
Access the latest, innovative technologies and deep technical expertise.
Processes are designed with cost, safety and scalability top of mind to reduce risk and enable a path towards commercialization.
Progress faster from preclinical development to clinical trials with optimized and GMP-compliant processes.
Processes are built for flexible tech transfer—whether in-house or to a partner of your choice.
Development Services in US and Europe
Process Development in Marlborough, MA, USA
Our process development service in Marlborough is powered by Sartorius’ comprehensive portfolio and a dedicated team of experts with deep understanding of our in-house technologies and the unique challenges associated with emerging therapies. Our state-of-the-art facilities include four PD suites and two GMP flex production suites. Uniquely situated at our center for bioprocess innovation, our Marlborough projects also benefit from early access to new innovative technologies and techniques.
Supported Modalities
- Immune Cells — CAR-T, Natural killer (NK) cells and tumor-infiltrating lymphocytes (TILs)
- Stem Cells — Mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs)
- Gene Therapy — Adeno-associated virus (AAV) and lentivirus (LV)
- Extracellular Vesicles — MSC-, iPSC-, and HEK293-derived
Project Capabilities for PD
- Technology Transfer
- Assay Development and Validation
- Media Optimization
- Process Scale-Up & Optimization
- Process Scale-Down & Optimization
- Engineering & Qualification Runs
- Clinical Production up to Phase 1
- Formulation | Fill
- Cryopreservation
Marlborough Service Highlights
Process Development in Lyon, France
Our process development service in Lyon delivers fully adaptable solutions tailored to your unique approach and innovations. We provide an integrated offering that includes GMP fill and finish, supporting you all the way through Phase 3 clinical trials. Our facility is authorized by EMA competent authorities (ANSM) for the manufacturing of sterile medicines and ATMPs, and received new GMP certificates in July 2025.
Supported Modalities
- Immune Cells — Natural killer (NK) cells and tumor-infiltrating lymphocytes (TILs)
- Adherent Cells - Mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and all other adherent cell lines
- Biological Products - Secretomes and Exosomes
Capabilities for PD and Clinical Production
- Technology Transfer
- Assay Development and Validation
- Process Scale-Up and Optimization
- Qualified Person for Product Release
- Sterile GMP Fill & Finish
- Stability Studies
- Storage Capabilities
Lyon Service Highlights
Connected Network to Meet Your Needs
No matter the location, scale, or project complexity, our experts are ready to help you achieve your goals and streamline your development journey. Our development and manufacturing services share one mission: to advance your therapeutic from concept to clinic quickly, cost-effectively, and safely. Each site is part of a globally connected network that shares knowledge, resources, and process expertise—continuously enhancing our capabilities.
