Equipment and Laboratory

	Equipment AssureImmune's adult stem cells collection and preservation services are seamless and automated. The company has invested in sophisticated equipment tailored for stem cell processing and world-class software systems to coordinate and track process, quality and storage data. Our state-of-the-art equipment was developed by Thermogenesis supported by GE Healthcare and is based on dual system which includes a processing and storage system for adult stem cells. AssureImmune’s State-of-the-Art Stem Cell Processing and Preservation Systems

Processing your Stem Cells with the AXP System
When the blood is collected, it is transferred under sterile conditions to a bar coded sterile processing kit comprised of special plastic compartments linked with tubing. The processing kit fits into a state of the art cell separation system called the AXP™ AutoXpress™. This system is completely automated and computer controlled. During centrifugation the blood components are automatically separated and the stem cells are concentrated in a natural plasma medium rich in white blood cells, proteins and other cellular components. After separation the stem cells end up in a 21 milliliter pouch that is double wrapped with a Teflon sheath and hermetically sealed to effectively quarantine our client’s cells from anyone else’s. Our equipment and system is designed to capture essential data for quality assurance and compliance with current good tissue practices. We have software that tracks and documents each blood unit’s separation data during and after centrifugation.

Storing your Stem Cells with the BioArchive System
Once the stem cells are collected and sealed, they are then encased in a stainless steel cartridge and transferred to the BioArchive system (shown below) for cooling and storage. The BioArchive is fully robotic and computer controlled cryopreservation system. Each client product is introduced into the system through an external port and transferred to the cooling chamber where it is cooled according to a process optimized for stem cells.

After controlled cooling, the sample is then frozen in liquid nitrogen and archived. The archive is isolated from the cooling chamber to ensure that stored samples are never disturbed by the introduction of new samples. This way we can assure that your cells are never warmed by accident.

Why is this picture important?

Exposure to outside elements can significantly deplete the number of viable stem cells! Don't treat your valuable cells this way. Today, most companies use freezers like the one shown to the left which involve racks and manual introduction of samples. Each time a new sample is introduced, the entire rack must be withdrawn from the freezer exposing stored samples to uncontrolled warming events. This type of warming exposure has been proven to destroy cells. Over time, multiple exposures can significantly deplete the number of viable cells available to you.and you have no way of knowing.

Managing Stem Cell Data
Finally all processing and storage data is then integrated into a single Enterprise Database so we can create a complete file for each client. Each client file includes process, storage, cell count, client history and laboratory test data for each product collected. We then provide our clients with a final account status report which refers to the amount and quality of cells collected. In addition, as part of our family banking services, we also track multiple deposits for families in the event that they need to be shared.

	Laboratory
	AssureImmune’s new facility features a state-of-the-art laboratory and cell storage archive that meets the American Association of Blood Bank and FDA recommendations for stem cell processing. Laboratory and archive facilities are designed to pharmaceutical clean room standards which include the use of non-shedding, non-porous cleanable materials for floors, walls and ceilings. Materials, processes and equipment are carefully integrated to ensure optimum processing control and cleanliness. Only authorized licensed laboratory staff will have access to enter the laboratory area. In order to process each client sample, they must log onto the computer system using their user ID and password. Client blood remains in a sterile environment from the moment it is collected. Throughout processing and storage the stem cells are never exposed to the environment. We ensure that your stem cells are handled properly by recording every step of our process.

All stem cell processing is done onsite with our AutoXpress Platform (AXP™) automated processing system.  Each set of sample data is logged in our system and available to clients.  We store cells only in the BioArchive® Cryopreservation System  because of its documented ability to protect cells for years.

Our Laboratory Staff
AssureImmune has licensed clinical laboratory scientists and medical technologists who are well seasoned in the quality assurance and process development and control aspects of running a blood collection and preservation facility.  Our team has collectively over 30+ years in blood processing experience from major biopharmaceutical companies including global healthcare company, Baxter International Inc.  We strive to recruit the best laboratory technicians and scientists in order to provide our company and clients with the best.