Antibody Drug Conjugate (ADC) Cleaning Validation: Managing Complexity Across the Product Lifecycle
Antibody drug conjugate (ADC) products introduce unique cleaning validation challenges in biotechnology manufacturing. The integration of small and large molecule components increases overall cleaning validation complexity and directly impacts cleaning methods, analytical strategy selection and limit setting, particularly for high potency compounds and degradation pathways.
Join this complimentary webinar to learn key cleaning validation and contamination control considerations for ADC products. Discover best practices for cleaning individual components and the final conjugate. Gain practical guidance on grouping strategies, analytical method selection and the establishment of degradation and exposure based limits. Additionally, explore how insights from the design phase can inform qualification activities and ongoing monitoring across the cleaning validation lifecycle.
Meet the Presenters
Paul Lopolito
Paul has over two decades of industry experience in pharmaceutical manufacturing and laboratory research settings, with expertise in process cleaning, cleaning validation and contamination control.
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He holds a bachelor’s degree in biological sciences.
At STERIS Life Sciences, Paul provides global technical support through field consultations, site audits, training presentations and educational seminars. He also manages the Process and Cleaner Evaluation (PACE™) program and analytical testing laboratory, which simulate Customer cleaning processes and support analytical method development and validation.
Paul is experienced in managing cross functional projects related to process cleaning and critical environment operations, with direct experience in the biopharmaceutical and biomedical device industries. He is a frequent speaker at industry events and has published several articles and book chapters related to cleaning validation and contamination control. He is also an active member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA).
Brian Bosso
Brian has over a decade of industry experience, with expertise in developing and implementing cleaning validation process lifecycles, process design, analytical method development and validation, risk assessments and regulatory remediation.
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He has held supervisory and management positions within multiple pharmaceutical and biopharmaceutical organizations. He holds a bachelor’s degree in chemistry.
At STERIS Life Sciences, Brian provides global technical support for pharmaceutical detergents and other critical environment products and applications.
Brian is an active member of the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE), contributing to ongoing industry knowledge and professional engagement.
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