Ensuring Safety and Compliance in Advanced Biotherapies: Evolving Standards and Testing Methodologies for Mycoplasma in Cell and Gene Therapy Manufacturing (26EL-600)

Please note: AABB reserves the right to make updates to this program.

• Educational Track: Technical/Clinical
• Topic: Biotherapies
• Intended Audience: CEOs, CFOs, COOs, Directors, Facilities that perform molecular testing, Hospital Blood Banks, Hospitals, Laboratory Staff, Managers/Supervisors, Medical Directors, Physicians, Research Scientists, Residents/Fellows, Scientists, Students (MD, MT, SBB), Technologists
• Teaching Level: Advanced, Basic, Intermediate

• Director/Moderator: Ronit Slotky, PhD, MSc, CABP, Director, Cell Therapies Manufacturing Facility, Hackensack University Medical Center, Hackensack, NJ
  Speaker: Cynthia Martino, Director of R&D, Bionique Testing Laboratories, LLC, Saranac Lake, NY

• Program Description

  Mycoplasma contamination poses a significant challenge in biopharmaceutical production and cell and gene therapy (CAGT), impacting product quality, safety, and regulatory compliance. These elusive bacteria, often undetectable by routine sterility testing, can silently sabotage cell cultures, leading to costly batch failures and jeopardizing patient safety.

  This program will provide the audience with comprehensive understanding of mycoplasma, its multifaceted impact, and the latest strategies for effective detection, control, and validation. The speaker will delve into:

  • The Dual Nature of Mycoplasma: Explore the clinical significance of mycoplasma as a pathogen and its detrimental effects on bioproduction and CAGT processes.
  • A Spectrum of Detection Methods: Discover traditional and cutting-edge testing strategies, from growth based compendial methods to widely adopted alternatives, comparing their strengths and limitations.
  • Navigating the Regulatory Landscape: Stay informed about the evolving regulatory requirements for mycoplasma testing, including pharmacopeial guidelines and agency expectations, with a focus on CAGT product development.
  • Phase-Appropriate Validation Strategies: Learn how to implement robust qualification and validation protocols tailored to different stages of development, ensuring compliance and minimizing risks.

  This program is crucial for scientists, quality control professionals, regulatory affairs personnel, and anyone involved in biopharmaceutical production and CAGT development.

  Learning Objectives

  After participating in this educational activity, participants should be able to:

  • Discuss the importance of mycoplasma including clinical significance and industrial impact.
  • Provide an overview of the regulatory landscape.
  • Discuss the evolution of mycoplasma detection methodologies.
  • Describe validation strategies for testing and implementing alternative testing methods.

  Registration

  Please note: registration for the live eCast is now closed. Registration is available for the on-demand eCast. If you registered for the live eCast you do not need to register for the on-demand eCast (access to the on-demand eCast was included with the live eCast registration).

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  Continuing Education Credit

  This activity is eligible for one (1) continuing education credit/contact hours for California Nurses, California Lab Personnel, Florida Lab Personnel and General Participation credit. AABB reserves the right to reduce or increase the number of credits granted based on the final activity duration. For more information on each credit type please visit our Continuing Education Credits webpage.

  There is no financial support for this activity.

  Claiming Credit
  Live Activity - Upon completion of the live activity, you will receive instructions to complete your evaluation, which is necessary to claim credit and receive your certificate of attendance/completion (credit must be claimed by the date provided in the instructions). The evaluation can be found by logging into the AABB Education Platform.

  Enduring Activity - Once the enduring (on-demand) program is available, you will receive instructions to access the AABB Education Platform. Upon completion of viewing the enduring activity, you will need to complete the evaluation, which is necessary to claim credit and receive your certificate of completion (credit must be claimed by the date provided in the AABB Education Platform).

  Program & Credit Expiration Dates:

  • Live Activity Program Date: January 14, 2026; Credit Expiration Date: February 14, 2026
  • Enduring Activity Program Dates: January 14, 2026 – January 13, 2029; Credit Expiration Date: January 13, 2029

  Disclosure Declaration

  It is the policy of the Association for the Advancement of Blood & Biotherapies to ensure independence, balance, objectivity, and scientific rigor and integrity in all of its CE activities. Faculty must disclose to the participants any relationships with commercial companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. AABB has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that the presence of such relationships will have a negative impact on the presentations.

  Disclosures for the planners of this event can be found here. Disclosures for the program faculty, peer reviewers, and AABB personnel are provided at the beginning of the program.

  Faculty Biographies

  Cynthia Martino is a specialist in rapid Mycoplasma test development and validation, primarily in the cell and gene therapy space. With over 23 years as a biotech professional, she has worked in biopharma analytical development, vaccine development, and discovery research, as well as contract testing and research. This culmination of experience has resulted in a valuable perspective which promotes a unique level of understanding when working collaboratively with clients to reach their experimental and validation goals. As an established expert in the field of validation of rapid testing methods, she has presented at numerous conferences and industry events, produced multiple webinars on the topic, and has served as a contributing member for multiple consortiums and collaborative studies with NIST, FDA, NIH, and CDC. Cynthia received her MS in Biology from East Stroudsburg University of Pennsylvania. Her master's thesis was on the use of cytochrome B analysis to determine the seasonal dispersal habits of female American Kestrels, as well as a comparison of both blood and feather samples to support this analysis.

  
  

  Ronit Slotky, PhD, MSc, CABP is a professor of oncology at Hackensack Median Health School of Medicine and the Director of the Cell Therapies Manufacturing Facility at the Hackensack University Medical Center. She earned her PhD at the Technion, Israel Institute of Technology in Israel, and completed her post doctorate at Columbia University Medical Center studying proteins' structure and function, as well her MSc in Biostatistics at Columbia University Mailman School of Public Health in New York. Dr. Slotky has been working in the cellular therapy field for over 15 years and has published numerous scientific articles in the field of cell processing. She is the chair of the AABB Cellular Therapy Section Coordinating Committee and a member of the FACT Quality Management Standards Committee. Her current work and research efforts focus on improving cell processing methods and patients' outcomes and providing education opportunities for clinicians and researchers.