As the field of cell manufacturing continues to evolve and expand, the importance of quality control cannot be overstated. Indeed, ensuring the safety and efficacy of cell therapies is essential for both patient health and the credibility of the biopharmaceutical industry. In this article, we will explore the critical role that quality control plays in cell manufacturing quality systems.
What is Quality Control in Cell Manufacturing?
Quality control (QC) in cell manufacturing is a set of procedures designed to ensure that cell products are consistently of the highest quality. These measures typically include:
Batch and lot release testing: To ensure that each batch of cells meets specific quality standards, manufacturers perform extensive testing before release.
In-process testing: Sample testing during the manufacturing process to prevent issues before they arise.
Material and component testing: Raw material must be tested to ensure it meets required standards at the start of manufacturing and additional testing must be run on the finished product to ensure it is functioning optimally.
Rigorous testing involves multiple levels of checks throughout the entire cell manufacturing process. The process requires careful tracking and documentation of the data received from each test, so cell manufacturers typically rely on complex and sophisticated software systems to manage QC processes effectively.
The Importance of Quality Control in Cell Manufacturing
As previously noted, QC is critical in ensuring that cell therapies are safe, effective, and consistent. Additionally, robust QC processes help to address issues early, thereby reducing the potential for costly and time-consuming remediation.
As cell therapy products are comprised of living organisms, ensuring quality requires more than simple pass/fail testing. Each step in the manufacturing process must get adequately managed to generate suitable products consistently. Manufacturer needs to invest in high-quality equipment to help ensure aseptic manufacturing, environmental controls that enable the growth of cells, and analytical equipment to measure cell quality.
Manufacturers preparing for commercial launch of their cell therapy products create cost modeling for QC planning. The assessment of the value position will help determine the degree of test control that should be implemented. Companies may also consider manufacturing strategies for each particular cell therapy. In oncology applications, for example, treating a patient with ex vivo cells that has finite tumor targets may have a less rigorous release testing versus a cell therapy that is meant to have extended survival or remission rate.
Furthermore, cell products’ QC plans must account for the unique characteristics of each cell type, including function, growth rate, and lifespan, among other things. For cell therapies used on patients, successful outcomes are reliant upon a trustworthy quality control strategy that ensures and provides proof to regulators that machinery and human skill are adequate to make safe and efficient cell therapy products.
Implementing Quality Control in Cell Manufacturing
Effective cell manufacturing quality systems require the use of advanced equipment and software, an experienced and trained staff, and rigorous record-keeping.
By leveraging automated software tools and real-time data collection, manufacturers can create a closed-loop QC system that allows for fast identification and resolution of quality issues. Additionally, manufacturers need to invest in the training of their workforce to understand the protocols to ensure that relevant testing is conducted appropriately.
Based on the production processes, a variety of techniques, including PCR, ELISA, flow cytometry, and gene sequencing, may be necessary to establish potency and identity standards. The most organized and coordinated systems ensure that the tasks surrounding testing are consistent and rigorously implemented.
Until recently, cell therapies have held orphan drug status, operating under minimal requirements to keep regulatory acceptance low. However, as the industry matures, the licensing bodies are raising the quality bar considerably. These changes will extend the requirements and demand greater oversight of supplier relationships, testing, and patient monitoring.
As cell therapies become increasingly popular, testing and cell manufacturing quality system releasing quality control processes become even more critical to ensure patient satisfaction. In the early stages of cell manufacturing, the goal was to produce working cells that showed efficacy. Nowadays, cell manufacturing needs to develop high-quality products, with detailed quality and control systems to identify and account for outliers that can increasingly compromise the efficacy and safety of cell products.
Manufacturers need to monitor their processes closely, create comprehensive QC plans, invest in advanced software and equipment, and develop well-trained, experienced, and documented staff to ensure successful commercialization of their cell therapy products. Effective QC requires highly skilled leaders to ensure that quality operations run as intended, so developing a company culture that values strict adherence and reporting of QC in all processes is crucial.