Our services

Establish GMP cell processing facilities

We can design and review the following crucial aspects of establishing a cell processing laboratory:

  • Objectives: what cell products are going to be made and in what quantities?
  • Capacity: what is the required size of the laboratory?
  • Standards: what standards does the laboratory need to meet?
  • Layout: what is the planned flow of materials and laboratory staff?
  • Safety: how are biological materials quarantined if needed?
  • Equipment: what equipment is required, including cleanrooms and cryopreservation equipment?
  • Qualification: how will you ensure that design specifications are met during construction and after completion?
  • Quality Management: what Quality System with associated document control is needed to meet standards?
  • Standard Operating Procedures (SOP): how are steps in the cell production process documented, from preparation to storage of final cell product?
  • Training: how will operators be trained in the SOP's?

Contract GMP cell processing facilities

Through our network and contacts we can locate cell processing facilities that have spare capacity and meet the desired specifications.

Validate GMP cell processing facilities

The validation process answers the following questions:

  • Installation (IQ): does the laboratory/facility meet the design specifications and is each piece of equipment properly installed?
  • Operation (OQ): does the laboratory/facility work as planned when a process is run?
  • Process (PQ): does a specific process produce the cell product that meets the product specification?