February 4, 2014 | by |

What is Cell Therapy Micro all about? First, as found in my mission statement, my primary focus is about protecting patient health by assisting cell therapy and regenerative medicine manufacturers in providing high quality and contamination-free products for their patients. Of course this is best accomplished through a variety of ways through an overall contamination control program or strategy.

Contamination control relies on a holistic approach in safeguarding products against adventitious, unwanted organisms. That means controls must be considered at all phases of the manufacturing process starting from the raw and ancillary materials that go into making the product, to the processing facilities, and all the way to the final finished products that that are given to patients, and even beyond. By beyond I mean that in the cellular therapy arena there has to be measures in place beyond just releasing the final product when considering the requirements for monitoring post-infusion reactions. For example, there is a real potential for significant implications or adverse reactions when a cell-product with a short shelf-life tests positive during traditional 14-day sterility culture after it has been administered or infused into the patient. Therefore, alternate and typically more rapid methods for sterility testing are increasingly being considered.

Some of the most significant areas of contamination control are 1) the adequate training and aseptic technique of the cell-process operators (as people are typically the most contaminated entity in manufacturing area, 2) the environmental controls and monitoring of the manufacturing area and utilities such as water systems, 3) the cleaning and disinfection of the manufacturing environment surfaces and materials, and 4) the validity of the microbiological testing methods used to evaluate the safety of the product. Cell Therapy Micro is positioned to assist you, the cell therapy and regenerative medicine manufacturer, in all these areas in order to control unwanted contamination.

Finally, I look forward to working with you in this exciting, emerging, and sometimes challenging field as we help to bring these new treatments to those patients who need them.

Cell Therapy Microbiology Consulting, LLC