Cell Therapy Manufacturing Services
Our hands-on cell therapy manufacturing services expertise spans a variety of autologous and allogeneic cell types and starting materials, including but not limited to:
- Immune cell populations (i.e. T-cells, NKs, Dendritic cells, etc.)
- Stem cells (i.e. MSCs, HSCs, etc.)
- Other cell types as needed
In addition, we have experience handling TILs, tumors (resections/biopsies/lysate), apheresis material including mobilized, whole blood, and buffy coat.
We offer three suite configurations for scalable needs:
- Validated ISO 7 Grade B production containment suites that are US FDA compliant and can be used for cell therapy production or viral transduction
- Validated ISO 7 Grade B production suites that are both US FDA and EU Annex 1 compliant for cell culture
- Validated ISO 7 Grade B production suites that are both US FDA and EU Annex 1 compliant for cell culture or viral transduction
Why Partner with Us for Your Cell Therapy Manufacturing?
Our teams are skilled in a variety of technology platforms that can be used in the cell therapy manufacturing process. Our years of experience enable us to provide you with insight on best practices and scale-up to not only improve safety, but decrease costs of goods for patients and industry as a whole. Our capabilities include:
- Manufacturing Science and Technology (MSAT) team
- Quality management systems (early phase through commercial)
- Quality control/release testing
- Regulatory support
- Clinical operations and logistics
- Technical operations
- Assay development
- Validation and qualification
- Process development labs
As a trusted cell therapy CDMO, we can manage all aspects of your product development lifecycle and associated supply chain. We manage supply chain integration, scheduling with several parties (i.e. apheresis centers and clinics), temperature, and/or controlled storage before, during, and after shipping with various providers. We also interface on your behalf with additional CMOs and/or regulatory agencies for global clinical trials and/or product roll-outs, as well as liaise with patient collections facilities and clients CROs.
Looking for support for your upcoming cell therapy manufacturing program?