Cell Processing Expertise
Ryan Crisman, Ph.D.
- Extensive experience in cell therapy CMC operations including development and cGMP manufacturing from Phase 1 to commercial-ready processes
- Strong CMC regulatory background for early and late phase cell therapy and protein molecules
- Broad experience in protein fermentation, purification, and formulation with expertise in biophysical characterization
Matt Seefeldt, Ph.D.
DIRECTOR OF CELL THERAPY
- Eighteen years of experience in biotechnology manufacturing, with an emphasis on translating early-stage therapeutics into the clinic.
- Developed six IND-enabling cGMP processes on both microbial derived proteins and cell therapy products. One of those products was successfully scaled to support Phase III clinical studies.
- Successfully completed the build out and GMP preparation of the Gates Biomanufacturing Facility .
- Considered a world expert in protein refolding
- Expert in protein stability and formulation, with specific understanding of the link between aggregates and immunogenicity
- Five – ISO 7 class clean rooms capable of processing minimally manipulated, expanded and genetically-modified cells
- Clean rooms operate at a minimum of 30 air changes per hour with single-pass HEPA-filtered air supplied by a dedicated air-handling unit
- One or two biological safety cabinets per clean room with built-in particulate monitoring probes
- Two cell processing clean rooms are equipped with vented biological safety cabinets for vector handling
- CO2 and O2 controlled incubators
- CliniMACS®Prodigy System
- Sepax C-Pro Cell Processing System
- Temperature-controlled centrifuge
- Automated cell counter – trypan blue, fluorescent dye compatible
- Barcode scanner for equipment and materials traceability