Hands-on Laboratory Bootcamp for Cell Therapy Biomanufacturing

ABOUT THE COURSE

This five-day, expert-guided, entirely hands-on lab training teaches you practical skills necessary to work competently in advanced therapy laboratories. In this course, you will learn aseptic cell culture techniques for adherent and suspension cells,  small and large-scale cell manufacturing, , product safety testing, product quality attributes characterization and GLP/GMP documentation.

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COURSE CONTENT
  • Overview of GLP and GMP lab safety and operations.
  • Operate essential lab equipment (e.g. bio safety cabinet, incubator, centrifuge, automated cell counters, plate reader, flow cytometer, LN2 storage).
  • Evaluate the cell quality attributes in culture.
  • Initiate, maintain, expand cells in culture (e.g. T- cells and MSCs).
  • Harvest and cryopreserve cells.
  • Set up cell manufacturing bioreactors and perform large-scale cell manufacturing (e.g., vertical wheel, wave, hollow fiber bioreactors).
  • Perform cell safety testing (e.g. endotoxin, mycoplasma testing).
  • Perform cell characterization assays (e.g. apoptosis, protein/cytokine assay).
  • GLP and GMP documentation and reporting.
  • Recognize key components of the updated Hazard Communication Standard (HCS) under the Globally Harmonized System (GHS).

ADDITIONAL MATERIAL INCLUDED IN THE COURSE

After registration, you will gain access to the following pre-reading materials in advance to help you prepare for the course:

  1. Lab Safety 101 online training
  2. General Biosafety online training
  3. Quality by Design, Cell Manufacturing Unit Operations, Process Development, Design of Experiments, Critical Quality Attributes (CQAs), and Critical Process Parameters (CPPs)
  4. Good Manufacturing Practices, Manufacturing Quality Control, Quality Assurance, and Sterility Testing
  5. Concepts in Scalable Bioprocessing of Cells
  6. Downstream Processing

LEARNING OUTCOMES

  • Apply aseptic techniques and good laboratory practices to work in cell culture and GLP and GMP labs.
  • Learn how to operate GLP/GMP lab equipment
  • Evaluate the cell quality attributes in cultures.
  • Learn how to initiate, maintain, expand, and cryopreserve suspension and adherent cultures (e.g. T cells and MSCs).
  • Expand cells using cell manufacturing equipment.
  • Perform cell quality and characterization assays.
  • Perform cell product safety and release assays.
  • Apply GLP/GMP guidelines to document cell products.

LOCATION

Petit Institute for Bioengineering and Bioscience & Marcus Center for Therapeutic Cell Characterization and Manufacturing, Atlanta, GA, USA.

Address:
Petit Institute for Bioengineering and Bioscience
Georgia Institute of Technology 
315 Ferst Dr, Atlanta, GA 30332

Marcus Center For Therapeutic Cell Characterization and Manufacturing
Georgia Institute of Technology 
345 Ferst Dr, Atlanta, GA 30332 

PRICE (USD)

Category IISCT or CMaT Member 
Academia $5,500
Industry $6,500
Students* $3,500

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For full details on our course policies, including cancellations, complaints and appeals processes and our privacy policy, click here.

UPCOMING COURSE DATES

August 12–16, 2024
May 5–9, 2025

  • Five-day intensive course
  • Hosted in-person at the Georgia Institute of Technology, Atlanta, Georgia, USA

Register for the August 2024 Course

Register for the May 2025 Course

DESIGNED FOR:

Graduated students and Industry professionals seeking hands-on training experience working in GLP and GMP laboratory. 


STRUCTURE:

Hands-on lab training, five days


ELIGIBILITY REQUIREMENTS:

UPON COMPLETION, YOU WILL RECEIVE:

  • A copy of the course materials
  • Certificates of course completion from ISCT-CMaT and CMLE

**ISCT is an ASCP Continuing Medical Laboratory Education (CMLE)-approved provider. This course consists of 30 CMLE credits.

CONTACT US

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

Contact

“A well-trained, readily available, diverse workforce is crucial to the success of the emerging cell and gene therapy industry, especially given its highly specialized skill sets, GMP and regulatory requirements, and complex manufacturing and supply chain infrastructure.

Our partnership with ISCT brings the largest cell manufacturing research and education consortium together with the largest global cell & gene therapy society to deliver critically needed workforce training for CGT. Together, we hope to develop a robust, on-demand, client-centric training platform for industry and clinical manufacturers.”
-Krishnendu Roy, Robert A. Milton Chair, CMaT

“ISCT has long identified and taken measures to alleviate the skills shortages across the cell and gene therapy sector. ISCT has run a range of courses across the CGT sector, including forming our ISCT Early-Stage Professionals (ESP) Committee, responsible for our extensive Mentoring Program. Despite these efforts, growth in the CGT sector continues to outpace the professionals entering. This is a major issue for the sector that could become critical in the near future."
-Bruce Levine, Immediate-Past President, ISCT

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