Webinar Series: Contamination Control for Cell and Gene Therapy
Explore holistic steps to reduce risk and optimize processes in CGT operations
Cell and gene therapy (CGT) operations share the same contamination control requirements as the broader pharmaceutical industry, which utilizes current good manufacturing practices (cGMP). However, there are unique challenges.
Our four-part educational webinar series explores the heightened risks of contamination in CGT and provides holistic steps that you can take to reduce risk and optimize processes for your operation.
Learning Objectives
During this webinar series, you will:
- Discover how to optimize operations while reducing risk
- Understand processes and techniques to adapt an existing environment for CGT
- Learn about the holistic approach to developing and maintaining your contamination control program
- Find out how to simplify processes to reduce training time
Best Practices for Cell and Gene Therapy Manufacturing
It is vital to establish a robust contamination control program for your CGT manufacturing process to protect your products and increase speed to market. STERIS's best practices document discusses common challenges experienced in CGT manufacturing and how to address them.
On Demand Webinars
Cell and Gene Therapy Operations and Contamination Control Programs
The first webinar in our series takes a look at how to develop a contamination control program to address some of the more prominent CGT challenges. We provide an overview of cleaning and disinfection frameworks to accommodate speed to market, operate within existing environments, movement of materials and staff training. Finally, we review CGT case studies to share how others are successfully implementing a contamination control program.
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Implementing VHP™ Biodecontamination in Cell and Gene Therapy Settings
This webinar introduces the basics of Vaporized Hydrogen Peroxide (VHP) and strategies to employ VHP as a decontamination method in aseptic manufacturing spaces for CGT operations. We review several VHP applications, including integrated, facility-wide, mobile and decontamination services.
Next, we offer guidance for choosing the appropriate deployment option for your CGT operation and explain the importance of combining VHP and manual cleaning for contamination control of aseptic spaces, including open cleanrooms, RABS, isolators and biosafety cabinets (BSCs). Lastly, we explore material movement best practices using VHP.
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Materials Movement and Contamination Control for Cell and Gene Therapy Operations
The third webinar in our series focuses on reducing the risk of materials becoming a transmission vector for microorganisms when they are transferred into an aseptic environment or staged for production activities.
We cover the development of mitigation measures, documentation and training strategies to reduce risk and improve productivity. We also review best practices for equipment preparation/wrapping, manual surface disinfection and disinfection using VHP pass-through chambers.
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Cell and Gene Therapy Panel Discussion
Our final CGT webinar reviews and responds to frequently asked questions received throughout the first three webinars in the series. This interactive discussion features a panel of subject matter experts who will provide insight and advice to help you overcome challenges.
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Meet the Presenters
Renee Buthe
Renee has over eight years of industry experience, specifically in cell and gene therapies.
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She has expertise in generating protocols for and performing environmental monitoring, airflow visualization studies and aseptic process simulations, reviewing batch records and authoring final reports. Renee holds a bachelor’s degree in biology with a minor in animal sciences.
Previously, Renee spent time in the quality and sterility assurance departments for WuXi Advanced Therapies and Algood Food Company.
At STERIS Life Sciences, Renee assists Customers with sterility assurance and sterility maintenance product applications, providing consultation on product application and contamination control best practices.
Renee is currently an instructor through the Parenteral Drug Association (PDA) training institute and an active member of the association.
Matt Hofacre
Matt has over two decades of experience providing sterilization, biodecontamination, water, steam and washing applications for the biopharmaceutical, medical device, food and beverage, biological containment and laboratory research industries.
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He holds a master’s degree in finance and marketing and a bachelor’s degree in chemical engineering.
For STERIS Life Sciences, Matt supports global Customers, regulatory and industry groups with consulting and technical guidance for contamination control strategies and sterilization applications. Related technologies include Vaporized Hydrogen Peroxide (VHP™) biodecontamination, VHP sterilization, moist heat sterilization, washing, pure steam production, purified water systems and equipment services. He is also a student of lean practices to maximize value stream to Customers.
The Parenteral Drug Association (PDA), International Society for Pharmaceutical Engineering (ISPE), INTERPHEX, ACHEMA and American Society of Mechanical Engineers (ASME), amongst others, have welcomed Matt as a presenter and trainer at several national and international conferences.
Matt co-authored PDA Technical Report No. 48 Moist Heat Sterilization Systems: Design, Commissioning, Operation, Qualification and Maintenance and has authored and contributed to numerous other articles on water for injection systems, steam sterilization, VHP and pharmaceutical equipment selection.
Daniel Klein
Dan has over two decades of industry experience, including working in research and development for microbiology and clinical affairs.
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He has also managed a contract testing laboratory. Dan holds a master’s degree in biology and a bachelor’s degree in microbiology.
At STERIS Life Sciences, Dan provides technical expertise to Customers and helps troubleshoot and solve contamination issues. He supports Customers with a variety of critical processes and general understanding of the latest developments in the industry. He frequently presents data and other information at international industry meetings and sponsored events.
Dan is an active member of ASTM International, the Association for the Advancement of Medical Instrumentation (AAMI), the Parenteral Drug Association (PDA), the Association of Official Analytical Collaboration (AOAC) International, the Institute of Environmental Sciences and Technology (IEST) and the Center for Biofilm Engineering (CBE). He previously served as Chairperson of the AOAC International’s Committee on Antimicrobial Efficacy Testing. He is an active participant in ASTM’s E35.15, E55.08 and D37 Committees and a primary member of AAMI Work Group 08.
Throughout his professional experience, Dan has authored numerous industry articles and book chapters in peer-reviewed journals related to disinfection and sterilization.
Juha Mattila
Juha has over two decades of experience in pharmaceutical, medical device, research and biosafety technologies.
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At STERIS Life Sciences, he is a Senior Manager of Technical Services for sterilization applications, equipment and critical utilities technologies. Juha’s expertise covers moist heat and Vaporized Hydrogen Peroxide (VHP™) sterilization, VHP biodecontamination technologies and Water-for-Injection (WFI) distillation and pure steam systems. He holds a master’s degree in business informatics and a bachelor’s degree in heating, ventilation and air conditioning (HVAC) and process engineering.
In addition to being an active member of the Parenteral Drug Association (PDA), Nordic Board member for the International Society for Pharmaceutical Engineering (ISPE) and the Finnish Biosafety Network, Juha has authored several technical articles and spoken at many industry events. He also contributes to the International Organization for Standardization (ISO), the European Committee for Standardization (CEN), Finnish Standardization Organization (SFS), American Society for Testing and Materials (ASTM) International and the British Standards Institution (BSI) work groups considering these technologies.
Juha coordinated the STERIS Life Sciences Equipment and Services commentary through the PDA for the European Union (EU) Good Manufacturing Practices (GMP) Annex 1 draft and participated in the PDA EU GMP Annex 1 Workshops in 2022 and 2024.
Aaron Mertens
Aaron has over two decades of experience in pharmaceutical manufacturing, with expertise in cleaning, disinfection, sterilization and contamination control.
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He has held several positions within the pharmaceutical industry, with experience working at pharmaceutical manufacturing organizations representing quality assurance programs and collaborating with global industry regulatory agencies. He holds a bachelor’s degree in genetics.
At STERIS Life Sciences, Aaron performs global manufacturing site evaluations and consultations to ensure compliance with international regulations. He is also responsible for providing global technical support for critical environments, sterility assurance and sterility maintenance application and validation.
Aaron is an active member of the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE). He previously served as President of the ISPE Great Lakes Chapter and is currently a member of the ISPE Sterile Products Processing Steering Committee.
Additional professional activities for Aaron include delivering technical content to the industry with posters, publications, virtual and live technical presentations, as well as leading global sterilization master classes.
Jim Polarine Jr.
Jim has over three decades of experience in cleaning, disinfection, microbial excursions and disinfectant validation and testing.
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He holds a master’s degree in biology.
Prior to joining STERIS Life Sciences, Jim worked as a Clinical Research Manager with the Department of Veterans Affairs in St. Louis, Missouri and as a Biology and Microbiology Instructor at the University of Illinois and McKendree University.
As a member of the STERIS Life Sciences team for the past 25 years, Jim’s current technical focus is on microbial control in cleanrooms and other critical environments. He conducts on-site training, webinars and high-level technical support for Customers in the biopharmaceutical industry.
As a 2019 Parenteral Drug Association (PDA) Michael S. Korczynski Award recipient, Jim was recognized for his contributions toward the development of PDA's international activities. Jim also received the 2024 PDA’s Distinguished Service Award for leading the PDA Missouri Valley Chapter for four years. He has given lectures around the globe on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. He has also published several PDA book chapters and articles related to cleaning, disinfection and contamination control.
Jim served four years as the President of the PDA Missouri Valley Chapter. He is also the current President Elect of the IEST Executive Board. He is an active member of the International Society for Pharmaceutical Engineering (ISPE), the American Society for Microbiology (ASM), the Society for Industrial Microbiology and Biotechnology (SIMB) and other industry associations.
Dedicated Scientific Support
Our technical services team, comprised of industry-recognized scientists and engineers, provides exceptional expertise in contamination control strategies, process optimization, regulatory compliance, validation support and quality assurance. Navigate complex regulatory landscapes, reduce operational risks and accelerate your time-to-market with support from our professionals.
Meet the Team