November 15, 2022 PAO-11-022-CL-04
The program was anchored by a series of presentations by members of the Ecolab team. In the first, Senior Microbiology Technical Consultant Don Singer presented “A Pragmatic Decontamination Program for Cell and Gene Therapy GMP Manufacturing,” discussing a holistic approach to contamination control across all manufacturing-related areas, ways to reduce cleaning and decontamination variables, and the characteristics of good disinfection programs. As Singer put it, “Holistic thinking means that you understand that every process step or room has a connection or entry point to a higher or lower classification area — and all of these need to be assessed and controlled appropriately to prevent microbiological cross contamination.”
Later, Global Technical Consultant Madison Hoal delivered a presentation on “Regimes and Rotation: Cleaning and Disinfection Frequencies for Regulatory Compliance,” which built upon Don’s talk to address sources of contamination and ways to limit the introduction of contaminates and to minimize their proliferation. Hoal expanded to discuss considerations in disinfectant and detergent selection, how to consider and eliminate residues, and best practices for cleaning regimes and rotations for optimal decontamination and regulatory compliance.
In a final, dynamic and hands-on presentation from Ecolab, Technical Manager for Bioquell David Root discussed the Bioquell Qube, a configurable ISO5 isolator system integrated with Bioquell’s hydrogen peroxide vapor bio-decontamination technology suitable for cell and gene therapy, small batch or cytotoxic production, sterility testing, and compounding, among other activities. After walking through a few slides showing the Bioquell Qube’s key characteristics and modular configuration options, Root led the audience out of the conference room to demonstrate a Bioquell Qube isolator that was set up just outside, where he explained the various components of the standard Bioquell Qube, its bio-decontamination cycles, real-time feedback displays, and minimal additional requirements.
“There are no shortcuts when it comes to developing, implementing, and monitoring a contamination control program,” explained Sumit Behl, Ecolab Vice President and General Manager – North America. “Today’s educational seminar on contamination control had an ideal agenda and setting for industry experts to share insights and best practices. We look forward to offering similar seminars, in other cities, to advance product, environment and associate safety.”
Most of the rest of the day’s program comprised a series of lively panel discussions featuring experts, not only from Ecolab but from companies involved in contract manufacturing, testing, engineering, cleanroom design, software, and industrial hygiene. Each of the day’s panels explored considerations, best practices, and future visions for one of four overlapping elements fundamental to success for all stakeholders in the biopharma space: contamination control, quality control, regulatory compliance, and bioanalytics.
In the first panel, Ecolab’s Don Singer was joined by Michael Fiske, Vice President of Manufacturing Sciences at contract development and manufacturing organization (CDMO) Scorpion Biological Services, and Mustaq Singh, Co-Founder and Head of Products at drug manufacturing software provider Leucine, to discuss manufacturing issues surrounding contamination control, safety, and quality relevant to cell and gene therapy and biotherapeutics manufacturing from their distinct perspectives, which span from biopharma software to biodefense. Collectively, they covered a wide range of activities that impact contamination and safety and discussed how innovations in each contribute to more comprehensive levels of control.
A second panel examining trends in cleanroom and facility design and construction that are helping to realize the facilities of the future featured Scorpion Biological Services’ Mike Fiske again, along with Peter Makowenskyj, Director of Design Consulting at cleanroom design and construction firm G-CON, and David Schmidt, Vice President of Analytics at CDMO Wheeler Bio. Each panelist explained some of the current pain points in biomanufacturing from the point of view of facilities and his vision of the facilities of the future — including both near and more distant futures — and what will be required to realize that potential. Additionally, both Fiske and Schmidt discussed current efforts by their organizations to build new unique, cutting-edge facilities — Wheeler Bio in Oklahoma City, Oklahoma, and Scorpion Biological Services in Manhattan, Kansas — and Makowenskyj weighed in on how to determine the best approach to cleanroom construction for a given project on the spectrum from stick-built to fully modular or PODular.
The third panel directly followed Madison Hoal’s presentation on cleaning regimes and focused on best practices for cleaning and to ensure regulatory compliance. Ecolab’s Hoal was joined on this panel by Kalpesh Patel, Chief Operating Officer for Hyde Engineering and Consulting, and Nancy M. McClellan, who serves on the Executive Board of Directors and as Treasurer for AIHA — the American Industrial Hygiene Association. While Hoal and Patel discussed bioburden control via bio-decontamination and optimal engineering for therapeutic products, McClellan related analogous considerations from a very different point of view: worker hygiene and safety. The panel further spoke about regulatory dynamics, the industrial Internet of things (IIoT), how the COVID-19 pandemic changed the paradigm of a healthy workplace, and the distinct contamination concerns among stainless-steel and single-use equipment.
Finally, the fourth panel focused on current challenges and solutions in bioanalytical testing. Mike Stump, Executive Director, Testing Operations at WuXi Advanced Therapies, and Tonya M. Morris, Global Segment Director, Antimicrobials Disinfectants & Virology (AD&V) at Nelson Laboratories, joined Wheeler Bio’s David Schmidt for this discussion. Topics covered include the slow evolution of microbiological assays, the importance of testing to CDMOs (and more specifically to contract testing, development, and manufacturing organization (CTDMO) WuXi Advanced Therapies), how to manage increasing volumes of manufacturing data and how else they can be leveraged, balancing precision with throughput and automation, and the future of bioanalytics.
Beyond the formal program, the event gathered an impressive group of attendees serving in leadership roles in diverse sectors within or adjacent to biopharma. In addition to the aforementioned companies, this included representatives from pharma and biopharma companies (GSK, Sanofi, Novartis, Regeneron), CDMOs (Goodwin Biotechnology, Minaris Regenerative Medicine, Tedor Pharma), CROs (Eurofins Lancaster Laboratories), clinical logistics providers (Globyz Pharma), architecture, engineering, and commissioning (CAI, DPS Global Group) and advisory and consulting firms (Verta Life Sciences, Longview Leader, PharmaBioSource), and other life science industrials (Sino Biological, Nu-Tek Biosciences). In addition to Q&A sessions at the end of each presentation or panel, there was considerable time allotted for socializing and networking, which was very successful. The wide breadth of stakeholders present enabled a unique and synergistic environment that allowed attendees to gain unique insights into the capabilities of companies in different industry sectors and understand potential avenues for growth, in addition to more direct business development activities.
“The entire day exceeded my expectations,” noted Ed Striefsy, Bioquell Regional Sales Manager – North America. “In addition to the excellent list of speakers and panelist, I really appreciated the opportunities to network and openly share learnings and experiences in a casual setting. Being able to connect with experts, from across the industry, was invaluable.”
David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That's Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.