Services

Cell Therapy and Protein product manufacturing, characterization, storage, and distribution


Cell Therapy and Protein product process development, consultation, and support

  • Batch record creation and refinement
  • Develop manufacturing SOPs
  • Quality manufacturing process and analytical methods
  • Build and activate Bills of Materials and SOPs for orders to manufacture, collect, process, and release products to patients

Quality Control (assays and testing)

  • Broad analytical platform that can be tailored for specific projects
  • Best in class environmental monitoring program

Quality Assurance

  • Robust electronic Quality Management System with cross-functional Quality Council
  • Dedicated Quality staff
  • Documented release of each cGMP suite after cleaning and change over for each manufacturing campaign
  • Equipment qualification program
  • Vendor qualification program

Regulatory (FDA) compliance and support

  • Assist with pre-IND FDA meetings
  • Assist with Chemistry, Manufacturing, and Controls (CMC) section of -IND preparation
  • Audit and review procedures, processes, and test results
  • Assist with labeling requirements
  • Monitor product non-conformances

Clinical Protocol Support from Facility Medical Director

  • Review clinical protocol
  • Ongoing study management and problem resolution