Process Development Service for Advanced Therapies
Advanced therapies – gene therapy, cell therapy, viral vectors, extracellular vesicles, and more – offer life-changing potential. But turning innovative science into scalable, clinically viable treatments is challenging: process variability, complex regulatory demands, poor scalability, high costs, and long development cycles due to a lack of innovative technologies. Navigating these complexities requires both cutting-edge technologies and deep expertise in process development.
At Sartorius, we simplify the path to success. Our Process Development Services for Advanced Therapies are designed to provide you with the tools, knowledge, and support necessary to bring your groundbreaking therapies to fruition.
Comprehensive Support for Your Development Needs
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- and iPSC-derived
Project Capabilities for PD
- Technology Transfer
- Assay Development and Validation
- Media Optimization
- Upstream Process Development
- Downstream Process Development
- Process Scale-Up and Optimization
Project Capabilities for Clinical Production
- Technology Transfer
- Process Optimization
- Engineering & Qualification Runs
- Clinical Production
- Formulation | Fill
- Cryopreservation
Benefits of Our Process Development Service for Advanced Therapies
Our process development service combines direct access to innovative technologies, process development expertise, and the comprehensive Sartorius portfolio. Leveraging such a comprehensive service simplifies your path to the clinic, reduces time to market and risk, and provides the necessary data package to support your journey.
Expertise With an Innovative and Collaborative Approach
We understand that developing the next generation of therapies requires continuous innovation and flexibility. Our team of experts will ensure that you benefit from cutting-edge solutions tailored to meet your specific needs, which could include advanced bioprocessing equipment, analytical tools, novel production techniques, continuous processing, and process automation.
Our process development expertise is built on years of experience and a deep understanding of the unique challenges associated with emerging therapies. Our specialists work closely with you to design, develop, and refine processes that are reproducible, scalable, and compliant with regulatory standards. This collaborative approach ensures that your therapy is developed efficiently and effectively, minimizing risks and accelerating time to market.
Innovative Solutions for Complex Challenges
Developing an advanced therapy is inherently risky, but comprehensive support throughout the development lifecycle and a proven portfolio of products and services forms an effective risk mitigation strategy.
Our portfolio includes a wide range of bioprocessing solutions, such as scalable bioreactors, cell culture media and other critical raw materials, filtration systems, cell analysis tools, purification systems and membranes, single-use technologies, automation and digital solutions.
In-Process Analytics and Advanced Bioprocess Modeling
A strong data package not only supports regulatory submissions but also provides valuable insights into the performance and scalability of your process.
Our Development Service for Advanced Therapies is designed to deliver comprehensive data packages that demonstrate the robustness and reproducibility of your processes.
We employ advanced data analytics and process monitoring techniques to generate detailed datasets that cover all aspects of process performance. This data-driven approach ensures that you have the evidence needed to support your therapy’s safety, efficacy, and manufacturability.
