Cell Processing

Cell Processing Expertise

Ryan Crisman, Ph.D.

EXECUTIVE DIRECTOR

  • 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

Cell Therapy Process Development Laboratory

  • Equipment mirrors cGMP cell processing equipment for seamless process transfer – 1:1 scale

cGMP/cGTP Cell Processing Clean Rooms

  • 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