This 3-day online course will detail the fundamental biological components for gene therapy and gene-modified cell therapies and outline important consideration for selecting the most appropriate vectors and specific safety aspects.
Critical biological information to enable understanding of the cell and gene therapy tools and therapies both existing today and coming in the near future.
The course will also address key points in manufacturing, purification and different technologies for each of the types of therapies addressed during the course.
The lack of standardization regarding modular single-use consumables will be discussed as well as methods for cell separation and scaling-up issues.
Participants will also be given a set of case studies to analyse from the perspective of the course and provide feedback to the course leader who will select a few for general forum viewing after anonymizing the person providing the analysis.
What will you learn?
Current and Emerging Therapies
From vaccines and antibody therapeutics to cell & gene technologies – gain insight into the latest emerging trends, their applications and future potential.
Cell & Gene Therapy Introduction
Learn about the key definitions, science and technologies behind today's growing cell & gene therapy market.
Understand why viruses are used to engineer and deliver gene-modified cell and gene therapies
Familiarize yourself with how viral vectors are engineered, and how this translates into purification techniques
Viral vector selection
Consider important factors for selecting the most appropriate vector for your product, including gene size and transfection efficiency
Understand how purification requirements, such as host cell DNA and residual empty capsids, are influenced by vector manufacture and end-use application, compare how these requirements differ between gene therapy and gene-modified cell therapies
Appreciate that specific purification techniques are influenced by specific purification requirements of your product, then consider the different tests available to assess purification including qPCR, ELISA and TC1D50
Who is this course for?
This course is directly applicable to people working on the manufacturing of gene therapies and gene-modified cellular therapies. Relevant departments will include:
- Gene Therapy Process Development
- Cell Therapy Engineering
- Cell Therapy Process Development
- Quality Control/Assurance
- Regulatory Affairs
- Final Release Testing