Hands-on Methods and Analytical Processes for Cell and Gene Therapy Bioprocessing

ABOUT THE COURSE

Developed by subject matter experts in CGT biomanufacturing from academia, regulatory, and industry; this three and a half-day, hands-on lab training is designed to advance your knowledge in establishing translational processes and competencies in foundational methods and analytical workflow. Apply ISO 20391-1 and ISO 20391-2 standards and gain practical hands-on experience working with immune and stem cells, transfections, and downstream analytical processes.

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COURSE CONTENT

Focus on translational services and biomanufacturing:

  • Bioprocessing equipment evaluation and compatibility
  • Gene editing and characterization
  • Introduction to flow cytometry and data analysis
  • Assay development with consideration of ISO-Standards and ICH-Q2(R2) Guidance
LEARNING OUTCOMES
  • Knowledge of key considerations for developing cell therapy processes and preparing for translation to GMP manufacturing
  • Framework for how to evaluate and implement new and emerging equipment and technologies in the CGT arena
  • Insight into standardization, foundational methods, and analytical assay establishment approaches
  • Develop and deploy a framework for standardized immune- and stem-cell workflows
  • Hands-on training in critical parts of gene modification of primary and stem cells
PLANNING COMMITTEE

RATES (USD)

Category IISCT or CMaT Member  Non-Member
Academia $5,230 $6,000
Industry $5,500
Start-Up $5,400

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CONTACT US

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DESIGNED FOR:

Research Scientists, Lab Professionals including Bioprocessing Technicians, Quality Control Analysts, Manufacturing Associates and Laboratory Technicians


STRUCTURE:
  • In-person at 10421 Wateridge Circle - Suites 150 & 250, San Diego, CA 92121
  • 3.5 day intensive course - Lecture and lab training
  • Small class size

ELIGIBILITY REQUIREMENTS:
  • Experience with cell culture and aseptic techniques  
  • Basic understanding of cell therapy biomanufacturing workflow & cGMP regulations
  • Basic knowledge of quality control/testing in cell therapy development
ASSESSMENT:
  • Testing modules
  • Laboratory practical evaluation

UPON COMPLETION, YOU WILL RECEIVE:
  • Course booklet
  • CMLE certificate upon completion


ISCT is an ASCP Continuing Medical Laboratory Education (CMLE)-approved provider. This course consists of 24 CMLE credits.