Quality Control in Stem Cells
Hunting the invisible
Hope Biosciences Quality Control technicians from left to right: Danish, Valeria, Kristian; and Supervisor, Aalmin.
As the basketball Hall of Famer, Phil Jackson, once commented, “The strength of the team is each individual member. The strength of each member is the team”. At Hope Biosciences, every department has to work together to produce our propriety HB-adMSCs. We know these stem cells hold the potential to improve the lives of those with debilitating afflictions and we strive to produce them in accordance with the highest standards. As a technician in the Quality Control department, I want to take some time to explain how QC fits into the stem cell manufacturing process.
The main purpose behind the Quality Control department is to ensure the safety, integrity, purity, and quality of our product. Before the manufacturing process can even begin, a tremendous amount of quality testing has to be completed. We regularly test the manufacturing laboratories to confirm each laboratory’s compliance with FDA issued Current Good Manufacturing Practices (cGMPs). If you want to make sure you’re being hygienic with food, then you clean the kitchen before cooking, right? It’s a similar idea for stem cell manufacturing, although the laboratories must adhere to a much stricter set of requirements than your typical kitchen! The QC department is responsible for testing and monitoring personnel and surface swabs, airborne particles, temperature, humidity, air pressure, and air flow for every laboratory in our facility — all of which is necessary to prevent any contamination of our product.
Hope Biosciences Manufacturing Technicians working in one of our laboratories.
Along with ensuring our laboratories meet all cleanliness specifications and are cGMP compliant, the QC department must also test every reagent used in the manufacturing process. What you first have to understand is that human cells are divas, so they can be difficult to grow and require a significant number of reagents. Our talented manufacturing team at Hope Biosciences actually makes a proprietary stem cell growth medium in house. It contains a lot of ingredients, each of which must be tested by QC and passed before it can be used in the lab. In addition to the growth medium ingredients are the numerous reagents required for the various stages of stem cell manufacturing, such as adipose tissue processing, passaging, cryopreservation, and final cell therapy packaging. By now you may be feeling overwhelmed by the sheer volume of testing we are responsible for, and sometimes we do too, but the work we do is what allows us to provide our stem cell therapies to our patients with the utmost confidence in their safety. And the testing isn’t over yet!
Well Plates like the one shown above are used to test samples to make sure they are sterile and safe to use.
Once every reagent has been tested and proven to be sterile and free of contamination, the exciting work of stem cell isolation and manufacturing can begin! When fat tissue samples first arrive at our facility, the QC department tests them to make sure they are free of contaminants. These fat samples contain the mesenchymal stem cells (MSCs) that are used to make our products, but they can also be contaminated upon arrival. This is because they’re coming from a person’s body, which can hold around 39 trillion bacteria, and we wouldn’t want some bacterial castaways getting a free trip to the lab where they can grow and multiply! Once we make sure there are no unwanted guests within the fat, the extraction sample is handed over to manufacturing, where they process it and extract the MSCs. From there, the process of cell culturing can begin. And, you guessed it, more testing!
Gram Stain Dyes used to test for the presence of bacteria, Hope Biosciences.
While most of the contamination risk is eliminated by having the culturing process done in a sterile lab and by thoroughly testing all reagents, contamination can still occur if inadvertently introduced by manufacturing personnel. After all, humans are the number one source of contamination in a lab! This is why the QC department tests in-process materials regularly at pre-determined stages of the manufacturing process. This includes used growth media, cell samples, and final cell therapy products. The used media allows us a glimpse at the environment the stem cells are growing in, so we can guarantee the stem cells are growing in sterile conditions. Cell samples and final therapies are tested to confirm they contain only pure MSCs, are free of contamination, and safe to infuse. I am always nervous at this point. Reflecting back on the countless hours of work put into the creation of this therapy from every member of the company can be anxiety inducing. It falls on the QC department to release the final therapies for patient use and that can only be done after we confirm its safety and quality. But when all is said and done, there is no greater joy than releasing a final therapy product that everyone can be confident in and that holds the potential to dramatically improve someone’s life.
The job of a quality control technician is never finished. It is a continuous process of testing and validating to ensure that all products and procedures meet every specification and remain in compliance with FDA standards. This is often much easier said than done. Our work is extensive and time consuming, but with great teamwork comes great outcomes. We are proud of the contribution we make; the long days and late nights are all worth it when every member of the entire Hope Biosciences team can confidently stand behind the quality and safety of the product we provide to our patients and banking customers.