Discover the role of bioassays in evaluating        X-ray sterilization's impact on SUS

Wednesday, June 3, 2026

Session 1:  10 a.m. CET | 2:30 p.m. IST | 5 p.m. HKT   

Session 2:  8 a.m. PST |  11 a.m. EST | 5 p.m. CET

 

Explore the critical role of bioassays in evaluating the impact of X-ray sterilization on single-use systems in biopharmaceutical manufacturing. This webinar, part of our Simplifying Progress series, dives into how bioassays support reliable cell growth performance and help ensure safe, efficient production processes. 

You’ll gain insights on comprehensive risk assessments associated with implementing X-ray sterilization, including regulatory considerations and clinical implications. With a focus on cell culture assays, this session highlights how bioassays are used to assess the effects of extractables and leachables on cell growth, which is an essential factor in bioprocess development. 

Recent studies indicate that X-ray irradiation can serve as a viable alternative to gamma sterilization, showing no significant differences in cell growth outcomes. You’ll learn how to confidently integrate X-ray sterilization into your manufacturing workflow while maintaining compliance and ensuring supply chain continuity. 

Join us to strengthen your understanding and drive safety and innovation in biopharmaceutical production. 

 

What You Will Learn:

  1. Evaluate the impact of X-ray irradiation on materials used in single-use systems.
  2. Discover how to assess cell compatibility and growth performance after X-ray and gamma irradiation.
  3. Learn how to implement risk assessments and toolkits for effective bioprocess management. 

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Meet Our Experts

Samuel Dorey, PhD

Principal Scientist Materials & Irradiation    

Samuel promotes and facilitates the application of alternative ionizing radiation technologies to gamma with X-rays. He has a strong focus on the radiation application effects on materials used in single use systems for biopharmaceutical processes. He is also a Sartorius representative for the Advanced Therapy Medicinal Products (ATMP) BioPhorum, which serves as a collaborative platform to advance ATMP development and manufacturing, including cell, gene, and RNA therapies.  

​​Dana Lena Raddatz, PhD​ 

Manager Confidence® Validation Services Laboratory   

Dana Lena Raddatz has been working for Sartorius since 2018, where she is Manager of the Confidence® Validation Laboratory in Goettingen, Germany.  She leads laboratory validation activities for sterile filter validation.