Cell-based and gene therapy products are growing and becoming a major component of the biotechnology industry. A recent initiative funded by NIIMBL brought together a collaborative of six partner institutions and their regional CGT industry partners. The goals of the WEBET project, or Workforce Expansion in Biomanufacturing Emerging Technologies, are to research the workforce needs of the sector, identify the technical skills and knowledge needed to develop, manufacture, and test these advanced therapies and finally to create hands-on curriculum that will produce well trained graduates ready to join this important biotechnology sector.
Download Labor Market Report Here: LABOR MARKET ANALYSIS FOR CELL AND GENE THERAPY TECHNICIAN WORKFORCE
On December 3, 2021, and January 24, 2022, InnovATEBio hosted WEBET Train-the-Trainer Webinars- view presentations here:
CELL AND GENE THERAPY TRAIN THE TRAINER WEBINAR 1 (Recorded December 3, 2021) Presentations include: CGT labor market research outcomes, technical skill standards for CGT technicians, course requirements, and newly developed lab-based curriculum on AAV production in HEK 293 cells.
CELL AND GENE THERAPY TRAIN THE TRAINER WEBINAR 2 ( Recorded January 24, 2022) Presentations include: Skill Standards and Curriculum for Training Cell and Gene Therapy Technicians, Regulatory Considerations for CGT, CGT Analytics, and newly developed lab-based curriculum on AAV production analytics and AAV transduction evalutation by flow cytometry, immunofluorescence and western blot.
CELL AND GENE THERAPY CURRICULUM
Small Scale AAV Production in HEK293 cells
SOP: Isolation of pAAV Production Plasmids Using ZymoPURE II Plasmid Maxiprep Kit
SOP: Transfection and Harvest of Viral Production Cells (VPC) 2.0-HEK293F for rAAV-CMV-GFP Viral Particle Production
Equipment Required for Training Cell and Gene Therapy Technicians
AAV Vector Manufacturing: Challenges and Opportunities
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) released Project A-Gene and Project A-Cell. These were multistakeholder collaborations to incorporate Quality by Design (QbD) principles into a manufacturing case study of a viral vector commonly used in gene therapies and a cell-based therapy. View or download a pdf of the case studies below.
Please register for an account first. If you already have one, log in here.