Essential Requirements for Setting Up a Stem Cell Processing Laboratory

Abstract

Ensuring the reliable processing of a high-quality stem cell graft is one of the key elements in the success of a stem cell transplant. In order to achieve this, the critical processes performed in any stem cell processing facility are:

• Overseeing the safe receipt/handling of donor stem cells

• Defining the product: its quality and characteristics

• Determining what, if any, manipulation is required for the transplant

• Ensuring product safety, including testing for infectious diseases as well as safe transport and delivery of the cells back to the hospital/patient

• Maintaining full traceability of the graft product.

In order to achieve this aim, the establishment of a robust stem cell processing facility requires careful planning of the building and design, including an understanding of the anticipated clinical workload and the projected future transplant activity of the program. This would then influence the determination of the physical space required and allow for growth. Also, the processing costs must be factored into the final calculation of the cost or revenue of a transplant episode, as this will inform all financial calculations.

The facility should also be clear about the range of processing capabilities to be undertaken and required by the clinical program, as this will underpin all the training required for the laboratory staff. The range of processing capabilities will evolve as the program grows both in numbers and complexity, requiring the consideration of automation and greater ex-vivo manipulation of the graft.

It is also important to factor in a quality system from the outset that anchors all processes in the facility with clearly defined standard operating procedures and attention to safety. This system should incorporate incident reporting and some form of audits.

Regulatory compliance requirements will vary greatly between countries. In general, a solid quality plan that addresses all local regulations, adherence to the principles of that plan, and documentation to support that adherence will likely allow the laboratory to comply with the regulatory frameworks.

It is important to have a close relationship with the clinical transplant program, as the quality and content of the graft is an essential parameter in determining engraftment and immune reconstitution, as well as in determining the incidence of graft-versus-host disease and relapse. The laboratory should therefore be represented at clinical transplant planning meetings so that expected collection dates and transplant dates are clearly communicated, and the laboratory staff has access to engraftment data that can, and must, be correlated with the stem cell collection data (CD34 count, total nucleated dose, and viability). This involvement of laboratory staff will assure that the clinical outcomes match the reliability of processing and can also serve to indicate whether processing standards are sub-optimal.

Cell processing is becoming increasingly commonplace as cell-based therapy is diversifying out of hematolo-oncology and into regenerative medicine. These developments are likely to intersect with the traditional functions of the stem cell graft processing laboratories, but will present opportunities for the expansion of work and the support of a wider range of activites. Laboratories will also likely be presented with novel challenges requiring ever more robust quality systems and specialized staff. Regulations will also need to evolve to encompass these more complex cell therapy products.