Cell Therapy Manufacturing: Strategy and Optimization

ABOUT THE COURSE

This 1 day in-person training course aims to provide you with advanced insight into design control, research & development, validation & scale up and clinical manufacturing topics.

Register for one of the two parallel tracks based on your experience and training needs. Guided by subject matter experts from industry and academia, learn practical approaches to real world issues through interactive case studies and group discussion.

COURSE CONTENT


TRACK ONE:
Investigational CGT Products: Development Strategy and Optimization

Learn the applications of instruments and assays to optimize the processes in developing and manufacturing investigational CGT products. Further hone your application and analytical skills by participating in real-world case studies.


TRACK TWO:
Commercialized CGT Products: Overcome Challenges in Developing and Manufacturing 

Learn strategies to troubleshoot and overcome common challenges encountered when developing and manufacturing commercialized CGT products, including CMC, GMP and Clinical Phase I / II / III trials. 

LEARNING OUTCOMES
  • Discuss common issues around the basics of CGT products and their categories.
  • Describe insights into advanced regulatory processes for design control in cell therapy manufacturing.
  • Share key factors to consider with your process development from bench to clinic
  • List Good Manufacturing Practices (GMP), preparation and submission of Investigative Medicinal Product Dossiers (IMPD)
  • Draft Investigator Brochures (IB), quality, potency and stability assessment of your product.
  • Understand the importance of manufacturing and validation processes that are crucial for ensuring safety, quality, and scalability in cell therapy manufacturing.
  • Attain a comprehensive understanding of clinical manufacturing practices, focusing on either academic or industry perspectives, through two in-depth case study activities.
PLANNING COMMITTEE

Wade Atkins
MS, MT (ASCP) SBB, CQA (ASQ)

Department of Transfusion Medicine at the Clinical Center of the National Institutes of Health
United States

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Lizette Caballero
BS, MT (ASCP)

The Janssen Pharmaceutical Companies of
Johnson & Johnson
United States

Diane Kadidlo
BSc, MT (ASCP) SBB

University of Minnesota
United States


PRICE (USD)

Training Course Only ISCT Members Non-Members
Lab Technologists / Pharmacist / Nurse Practitioner / Nurse $265 $390
Students / Resident / Fellow / Postdoc $125 $245
Academia $300 $475
Industry $350 $525
Training Course + ISCT 2024 Annual Meeting  ISCT Members Non-Members
If you are registered for the Full Conference, attend this course for only $75! $75 


Receive 15% off when registering five or more people from the same company/institution!

Cancellation Policy:
Registration cancellation must be made by email to isct@isctglobal.org at least five (5) business days before the course start date. A 10% administrative fee is applied to all cancellations. Registration fee is non-refundable if it is cancelled within five (5) business days of the course start date.

UPCOMING COURSE DATE:

Saturday, June 1, 2024
08:00-15.30 PDT


REGISTRATION:
  • Hosted at the ISCT 2024 Vancouver Annual Meeting, this training course is open to both ISCT 2024 delegates and non-delegates.
  • The course is a stand-alone event outside the ISCT 2024 Annual Meeting.
  • Separate registration and fee are required to register.

 

DESIGNED FOR:

Research and development staff working with Cell and Gene Therapy Products (CGTs)

  • GMP managers and GMP production professionals
  • Professionals working in Clinical trials
  • Professionals working in Quality assurance and control

STRUCTURE:

1 day in-person interactive training course, hosted at the ISCT 2024 Annual Meeting in Vancouver Convention Centre, British Columbia, Canada


ELIGIBILITY REQUIREMENTS:

  • None
UPON COMPLETION, YOU WILL RECEIVE:
  • Certificates of course completion from ISCT.
  • ISCT is an ASCP Continuing Medical Laboratory Education (CMLE)-approved provider. This course consists of 7 CMLE credits.
CONTACT US

    If you need help with registration or have questions, please contact us.

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    Essentials of Cell Therapy Product Manufacturing, Qualification and Validation

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