Here, Trevor Marshall, director of global engineering at Zenith Technologies, goes into detail about how integrating and automating cell therapy production with manufacturing execution systems (MES) will help grow the personalised medicine sector and ultimately benefit patients worldwide.
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The growth in the clinical adoption of advanced cell therapies is one of many indicators showing an increased focus on personalised medicines. As anticipation builds around cell therapy and the promise it holds, more attention is being paid to the manufacturing strategies that will allow it to benefit more patients.
High costs, logistical challenges and antiquated approaches to documentation associated with the current processes present a formidable roadblock to the industrialisation of cell therapies. This is creating a need for cost effective, reliable and efficient ways of working which will be imperative to its success. The answer, in my opinion, is integrating and automating the cell therapy process through manufacturing execution systems (MES).
Cell therapy as it stands
Cell therapy involves genetically modifying a patient’s immune cells. White blood cells (T-cells) are taken from a patient and transported to a dedicated lab, these T-cells are then programmed to attack the disease in the person at a cellular level. Once modified the T-cells are grown and multiplied before being returned to the patient for injection. This therapy is typically performed at designated hospitals with specialised labs available to execute the cell therapy process.
The cold chain transportation of the patient’s blood cells in vials between the hospital and lab is a very important aspect logistically. Currently, the patient’s blood cells are frozen in vials before being sent to the lab and patient data is coded and anonymised before entering the lab. Once the cell therapy process is performed the patient’s blood cells are re-frozen and sent back to the hospital.
While cold chain logistics isn’t new to the pharma sector, we are seeing an emergence in the outsourcing of the cell therapy process to dedicated lab facilities, which can service multiple hospitals in a region with the ability to cater for different treatments. The upshot is an increased demand for specialist logistics contractors which will need to be met to ensure the cell therapy market is adequately serviced.
Role of automation and MES
Cell therapy is now moving from a manual oriented lab environment to identifying production scale principles from the larger scale bioprocess industry and applying some of these best practises with a goal of making the process as robust as possible, error free with reduced costs.
The cell therapy process by its nature requires the tracking of a patient’s blood cells through multiple, sophisticated pieces of lab equipment.
The blood cells pass through the equipment using disposable single-use bags. With more than one patient’s blood cells flowing through the lab it is critical that the manual steps are tracked, and all critical activities are verified by more than one person. Currently, many of the steps in the lab are manual with records stored on paper.
This is where the introduction of MES to the lab and automating the tracking of the patient’s blood cells through the system can offer significant value. Electronically verifying the process negates human error and can also improve throughput for a lab.
More importantly, MES offers a means of reducing risk by alerting operators to problems that could have catastrophic consequences. Once the patient’s blood cells are manipulated they are multiplied for many days with the use of a wave bioreactor. Most labs are unmanned at night and integration to the MES system to cater for equipment alarming and alerting is imperative. These alerts are then used to trigger a call out to the lab to investigate any problems. Cell therapy is often a last resort for patients, a delay or failure to return their modified blood may lead to the worst possible outcome.
Single-use technologies
Single-use technologies are imperative to the cell therapy process. Currently, there are many manual aseptic connections required, which increases the risk of connection failure in the process.
Manufacturers are working to create pre-made disposable bags already interconnected specific to individual processes, this reduces the need to tube weld separate aseptic bags together, thus reducing manual activities involved in the process. These bags are also identifiable via printed barcodes, which can be scanned by the MES for traceability purposes through the process before disposal.
Final thought
Cell therapy treatments are truly personal, with the process being carried out for a specific person on their blood cells. This is unlike traditional drug treatments where the manufacturing process is very much removed from the dispensing of the drug to a future unknown patient by a chemist.
The success in cell therapy treatments will lead to an increased number of hospitals that will offer these treatments and to the outsourcing of cell therapy process to dedicated lab facilities servicing multiple hospitals in a geographical region catering for many different cell therapy treatments.
However, the rate and scale of this growth will depend on the pharma industry’s ability to make cell therapy more affordable. Automation and MES are two vehicles that will play an important role in making labs more efficient and lower-risk which will lead to increased adoption, to the benefit of patients around the world.