published by Bill Paulson on July 16th, 2018 in ‘International
Pharmaceutical Quality (IPQ)’ (https://www.ipqpubs.com). Link to original article. Reprinted with permission.)
Experience with in vitro fertilization (IVF) clinics is sending a strong signal that applying significantly heightened air purification standards and more advanced technology to meet them may be critical across all cell culture/processing operations.
The learnings from a deep exploration of periodic dramatic declines in the success rate being seen in IVF processes and the effort to mitigate them were articulated by LifeAire Systems Founder and CEO Kathryn Worrilow at the ISPE “Facilities of the Future” conference, held in Bethesda, MD in late February.
Worrilow played a leadership role in a major Pennsylvania-based IVF clinic affiliated with Penn State University where she is a professor, prior to leading the charge in expanding the use of the LifeAire technology in healthcare and life science facilities.
At the ISPE conference, she told the compelling story of:
- the research and drivers in her IVF clinic that led to the development of the significantly enhanced air purification technology that LifeAire is now offering
- why the enhanced purification capability is important for cell processing, and
- the results that are achieved.
“What led us to develop the LifeAire System,” she explained at the beginning of her talk, was “the painful lessons of the impact of subtle levels of airborne pathogens on successful in-vitro culture and processing of living cells.”
While her focus has revolved around the human embryo, “the worlds of biopharma and the life sciences are not that different,” she told the meeting attendants. The living “cells with which we work have no mechanisms of defense. They are completely at the mercy of their environment – to the tissue culture growth media, to the sera, the protein that sorts them, the tissue culture oil, the air. And these cells – whether it be the human embryo, or those involved in cell/gene therapy, regenerative medicine, stem cell culture – carry tremendous therapeutic and life potential.”
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.”