BioCision was founded in 2007 by Rolf Ehrhardt and Brian Schryver when they realized, having spent many years in the clinical and laboratory environment, that there were critical unmet needs in the handling of temperature-sensitive biospecimens and biologics.
ADVERTISEMENT |
The rapid adoption of their first product—CoolRack thermo-conductive modules—confirmed their assumptions. Customers quickly began asking for different formats, and the BioCision cooling product platform quickly grew, eventually evolving into the new BioT (Bio-Transport) temperature stability systems.
The company’s CoolCell passive controlled-rate cell freezing platform replaced outdated methods of using alcohol to slow freezing rates, and became the standard for passive cell freezing around the world. It was adopted by ATCC, the largest biorepository for authenticated biological materials.
Ehrhardt, who earned his M.D. and Ph.D. with distinction from the Technical University of Munich, shares some of the essentials on this innovative solution.
Quality Digest Daily: What prompted the development of this product line?
Dr. Rolf Ehrhardt, President and CEO of BioCision |
Rolf Ehrhardt: The BioT platform was developed as a direct response to a need to package a product at ultra-cold temperatures using a manual process. One obvious solution would be to build a walk-in –80° C freezer and invest in parkas and thick gloves; however, the danger and discomfort of that situation would not be acceptable, not to mention the difficulty of manipulating small vials wearing that level of protection. The best solution would be to allow workers to remain at room temperature and to manipulate the products using tools as the product rests in an ultra-cold temperature environment.
QD: Why are the low temperatures so necessary?
Ehrhardt: Our products are used for pharmaceuticals and biological drug products that absolutely cannot be exposed to temperatures above –50° C and preferably not above –60° C. We are dealing with therapeutic products that are very tightly regulated and processes that are highly scrutinized.
By virtue of the greater density, holding cold gas in a well is a simple solution. However, in a static condition, the temperature will form a gradient, leaving a significant volume of the well above the temperature limit. Trying to grade biosamples that have been subjected to such temperature gradients is comparing apples to grapefruits. To counter this, the BioT combines a thermally conductive liner that also retains an elevated refrigerant so that the well interior gas is mixed by cold gas falling in the gravitational field. This greatly expands the usable temperature zone within the working cavity.
QD: Are there regulatory issues involved?
Ehrhardt: For companies dealing with pharmaceuticals, any or all of ISO 9001, ISO 13485, ISO 17025, and ISO Guide 34 can come into play. The remaining quality issue was the record of compliance. For this we needed to establish a working zone limit and monitor and record the temperature within that zone so that a data record could be established for regulatory purposes. This was a little tricky because we were dealing with an open-top system, and a technician may have trouble visually ranging a vertical zone limit, and we had to eliminate the subjectivity. To solve this we designed ultra-cold zone laser modules to cast a flat fan pattern across the interior of the cavity at the upper zone limit. Any object in the cavity that crossed the zone border would be marked by a bright red line of light, making it very easy for the technician to know where the upper limit was. To establish a record of working-zone temperature, the BioT was equipped with a border array of temperature sensors around the cavity interior situated exactly at the level of the laser light fan. In view of gas density increasing with decreased temperature, the location of the sensors was positioned at the highest temperature of the working zone; therefore, any temperature below that point had to be colder. The temperature sensors feed the input of a graphic data recorder to satisfy the quality conformance documentation, and once the system was calibrated, the operation was reduced to a workable protocol.
QD: Why now?
Ehrhardt: The now aspect is the result of the emergence of new technologies. "Live" therapeutics are coming of age, and the product-handling and cold-chain infrastructure needs to quickly catch up to the new demands of this novel situation. The field is also moving at a very rapid pace, and new solutions have to be developed at a similar pace. BioCision is poised to address another gap in the temperature-sensitive handling chain by introducing the first automated cell and biospecimen thawing system—ThawSTAR—in December. This product will have far-reaching implications for standardizing research protocols, as well as clinical standard operating procedures, as it changes the way drug products are thawed/processed in Research and Drug Development.
Add new comment