Technology Flows from Understanding Unmet Need
Worrilow went on to tell the story of her clinic’s experience with trying to understand the causative factors of periodic rapid drop-offs from the normally high IVF success rates at the clinic. These anomalies took place in spite of having a well-designed lab that met all normal ISO 5, GMP and SOP clean room standards.
Careful analysis of the data and correlation with incidents happening at the adjacent hospital and outside environment led to the realization that these normal clean room processes were not up to the control of airborne chemical and volatile organic compounds (VOCs) that were acting as cellular and molecular toxins.
In turn, an intensive analysis of the data allowed the clinic to understand the airborne metrics “truly necessary” to support the optimal in vitro culture of living cells.
The focus previously had been on nonviable and viable particulates. “What we had not focused on were volatile organic compounds – chemical pathogens. “What we learned is that all three categories are highly cytotoxic to our human embryos and were impacting our implantation in our clinical outcomes.”
Worrilow’s clinic now understood the impact of low level chemical and biological airborne pathogens on successful living cell subculture. The problem was that the air purification technology had to be developed de novo to make use of this understanding. “It was really the absence of a solution that led to the genesis of this technology,” she explained.
The purification technology needed to be different in:
- being designed based upon 15 years of clinical and air testing outcome data
- delivering chemical and biological pathogens at below detection levels on a single pass at reduced air changes per hour (ACH)
- providing 24/7 real-time kill/remediation of all airborne bacterial, viral and chemical pathogens
- being tested in the most sensitive environment
- having no byproducts, ozone or intermediate molecules produced, and
- offering a technological paradigm shift.
Worrilow pointed to the dramatic results that her clinic achieved and that are being reported from the various locations in which the technology has been installed – showing over a 50% improvement in the IVF success rate.
She concluded by stressing the impact that parts per billion VOC levels and low levels of viable particulates have on successful living cell culture, which are not addressed by current GMP and ISO metrics – an impact that has high significance across the cellular/regenerative medicine arena.
“Capture filtration, laminar flow, control of air flow, high air change rates and current in-duct and in-room technology are not enough to comprehensively remediate all categories of airborne pathogens from the clinical and life sciences environment,” she said. In turn, “aggressive management of the clinical and life sciences environment must involve strategies for staff, patients, residents, surface and air disinfection.”