Rizwan Sharnez
President
Cleaning Validation Solutions, LLC
Dr. Rizwan Sharnez is a biotech, pharmaceutical and medical device consultant. He has over 30 years of leadership experience and has worked with over 50 clients. Previously he was with BioSeparations, Merck, BMS and Amgen, where he was Sc. Director. He also served on the EAB of BioProcess International, Journal of Validation Technology and Journal of GXP Compliance.
Rizwan’s expertise is in the development, validation, monitoring and life-cycle management of pharmaceutical processes. He has also authored over 100 scientific publications and presentations, holds 16 patents and has received numerous professional awards. Rizwan also led the development of several peer-reviewed industry whitepapers, and has contributed to several guidelines, monographs and books on cleaning validation.
Rizwan has a B. Tech, M.S. and Ph.D. in Chemical Engineering and is an alumnus of the Indian Institutes of Technology. He can be reached at RSharnez@CleaningValidationSolutions.com or 720-745-2978.
DAY 2: May 29th, 2026
SESSION: Degradation of Therapeutic Proteins during Cleaning: Implications for setting acceptance limits for cleaning validation
◆ Chemistry of protein degradation.
◆ Regulatory expectations.
◆ Bench-scale degradation studies.
◆ Current trends and challenges.
◆ Acceptable exposure of inactive protein fragments.
◆ Leveraging degradation to set achievable acceptance limits.
