As more and more cell and gene therapies are being developed, there is an emerging need for the industrialization of cell manufacturing. With greater production also comes more regulation, and the industry is in need of processes that are scalable and still meet the requirements of Good Manufacturing Practices (GMP) for cell manufacturing.
Cell and Gene Therapy Manufacturing
Cell and gene therapies are overlapping fields of treatment. While the end goal of both cell and gene therapies is the same – to treat and potentially cure diseases – the approach is somewhat different. Cell therapy is the transplantation of cells in order to replace or repair damaged tissues and/or cells in the body. The cells are extracted from the patient, enriched and reintroduced into the body. In the case of autologous transplantation, cells are harvested and given back to the same patient while allogeneic transplantation involves transferring cells from a healthy donor to the patient’s body. Sometimes it is important to modify the cells before they are given to the patient, and this may involve transferring or altering the genetic material within the cells. This is known as gene therapy.
The manufacturing process for these therapies are largely manual and highly laborious. They often require open processes that are difficult to scale, are at risk of human error, and can result in increased batch-to-batch variability. When manufacturing cells, it’s important to acknowledge that any change, no matter how small, to the cell environment may result in an alteration of the product quality. For example, any changes to the cell isolation, separation, or cryopreservation process may reduce the safety and efficacy of the final cell therapy product. This is not to say that the manual manufacturing process is entirely flawed, but in order to comply with GMP, the process should be simple and reproducible. The greater the simplification and reproducibility of the process, the more efficient and cost-effective a life-saving therapy, such as CAR-T therapy, will be.
The Cell Washing Process
Cell and gene therapies, whether autologous (patient derived) or allogeneic (donor derived), begin with the extraction of cells from a donor or patient. The cells may then be manipulated in various ways, i.e., enrichment, selection, expansion, differentiation, or cryopreservation, before they are ultimately provided to the patient. Each of these steps utilize various buffers, media, growth factors, cryoprotectants, etc., and procedures that may be detrimental to therapeutic use. For example, the transfusion of cryopreserved blood products has been associated with adverse clinical outcomes, brought on by factors such as free hemoglobin, excess potassium, and other contaminants that are added or that accumulate during cell storage. To avoid these outcomes, volume reduction or “washing” is performed to remove harmful contaminants prior to patient transfusion. This is an essential step in the safety and efficacy of cell and gene therapy. Cell washing ensures a greater cell purification, making the cell therapy for which they are intended that much more safe and effective.
GMP Cell Manufacturing
Good Manufacturing Practice (GMP) is a quality assurance tool which is used across a range of industries, including medical manufacturing of human drug and biologic products. The intent of GMP is to ensure that pharmaceutical products have consistent strength, purity and quality. GMP guidelines provide quality assurance for all aspects of manufacturing, from equipment and staff training to operational processes and storage conditions. The automated cell processing provided by products such as the PXP®-LAVARE System are GMP compliant, giving doctors and other medical professionals peace of mind that the cell therapy they’re providing to their patients is of the highest purity and quality.
The Benefits of Automated Cell Processing
Automated closed cell processing methods can reduce the risk associated with open operations, and mitigate the danger of microbial contamination. Automation can also minimize the chance of human error, and save both time and money in the manufacturing process. The ability of an automated system to effectively process each patient’s valuable cells can be a tremendous benefit of cell therapies, such as CAR T-cell therapy.
How the PXP® LAVARE System Can Help
The PXP®-LAVARE System is designed to wash, re-suspend and volume reduce cell suspensions in a sterile, closed procedure. It is a simple, yet powerful sedimentation-based system that allows for controlled washing, multiple media exchanges, and volume reduction of a cellular sample into fresh media or buffer. Volume manipulation, media exchange and cell washing can occur without compromising cell viabilities or recoveries.
The Main Takeaway
This closed washing, automated system minimizes the risk of contamination, and reduces human error, while presenting a high recovery and viability rate. The PXP®-LAVARE System provides exceptional results, dependably high recoveries, rapid washing of samples in minutes, and provides seamless data tracking and documentation through its DataTrak software for GMP compliance. When it comes to patient health, efficiency with time and money are of the utmost importance. Our team at ThermoGenesis has a mission to make life-saving cell therapies accessible to as many people as possible, and we believe that through automation of cell processing and cell manufacturing, we are one step closer to doing that.
ThermoGenesis Holdings, Inc. is a pioneer and market leader in the development and commercialization of automated cell processing technologies for the cell and gene therapy fields. We market a full suite of solutions for automated clinical biobanking, point-of-care applications and large-scale cell processing and manufacturing with a special emphasis on the emerging CAR-T immunotherapy market. We are committed to making the world a healthier place by creating innovative solutions for those in need.
For more information on our entire suite of automated solutions, please contact our sales team.