Viral Vector Selection and Manufacturing for Cell and Gene

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Course Overview

 

Viral Vectors play a major role in both gene and gene-modified cell therapies. When genetic materials needs to be delivered into a cell a viral vector is often used. There are significant options available to scientists depending on the application. Poor knowledge of viral vectors may lead to mishandling or inappropriate vector selection which could sabotage your therapy and compromise patient safety.

 

This training course will examine the underlying science of viruses and how a viral vector is manufactured. Once completed, you will have the knowledge and understanding to select the most appropriate viral vector for your therapy. You will also study in detail the purification techniques in accordance with the regulatory requirements. You will learn aspects such as: how vectors are engineered, how gene size and transfection efficiency influence vector selection and then finish off by contrasting purification requirements and techniques between vectors used for gene and gene-modified cell therapies.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives

  • Understand why virus are used to engineer and deliver gene-modified cell and gene therapies
  • Examine how viral vectors are engineered, and how this then translates into purification techniques
  • Consider important factors for selecting the most appropriate vector for your product, including gene size and transfection efficiency.
  • Understand how purification requirements are influenced by vector manufacture and end-use application
  • Compare the regulatory and technical differences of viral vectors used in gene therapy and gene-modified cell therapies
  • Review the various tests available to asses purification including qPCR, ELISA and TC1D50
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1
FREE to Attend

60 mins

Overview of viruses used in cell and gene therapies

  • Review various types of viruses used in CGT
  • Learn how virus selection is dependent on application
    • Learn why and some of the challenges
    • Integration with host cells
    • Understanding that a virus must be integrative but non-replicative
  • Examine examples of viruses used in CGT applications
    • Lentivirus
    • Adenovirus
    • Review gene therapy viruses
    • Examine cell therapy viruses
  • Examine the differences between viral vectors used in gene therapies and cell therapies
Module 2

90 mins

Understanding viral vector manufacturing principles

  • Examine how viral vectors are manufactured
  • Review plasmid design
  • Understanding the different technologies available and when to use what
  • Analyse contamination challenges to ensure patient safety
    • Discuss media
    • Cell culture challenges
  • Examine scaling up form lab to clinical trials
  • Facility requirements
Module 3

90 mins

Choosing a vector – part 1

  • Learn what must be considered when choosing the right vector system
  • Ex vivo vs in vivo gene therapies
  • Discuss naked nucleic acid therapies
  • Discuss in detail the difference between cell and gene therapy viral vectors
Module 4

90 mins

Choosing a vector – part 2

  • Review the challenges of large genes
  • Discuss distant enhancers influence on vector design
  • Examine target cell issues
    • Low expression of receptors for infection
  • Discuss transduction efficiency
  • Review serotype efficiency
Module 5

90 mins

Viral vector purification – part 1 – Regulatory requirements

  • Review the impact of bacterial and producer cell DNA
  • Discuss other impurities
  • Understand the different requirements between gene therapy and gene-modified cell therapy
  • Host cell protein requirements
  • Residual empty capsid
  • Residual host cell DNA
Module 6

90 mins

Viral vector purification – part 2 – Techniques

  • Understand the techniques available to purify viral vectors
  • Learn when each technique should be used and why
  • Appreciate there are elements that cannot be seen
  • Examine the following:
    • ELISA
    • q PCR
    • HPLC
    • TCID50
    • Replication competent lentivirus detection
Module 7

90 mins

Viral vector purification – part 3 – Techniques

  • Understand the techniques available to purify viral vectors
  • Learn when each technique should be used and why
  • Appreciate there are elements that cannot be seen
  • Examine the following:
    • ELISA
    • q PCR
    • HPLC
    • TCID50
    • Replication competent lentivirus detection

 

Dr.Lars Brandén has long experience from the fields of viral and non-viral gene delivery, high throughput screening and cell based assays. Dr. Lars Brandén has a career that encompasses start-up of gene therapy companies, building and operating several high throughput cell biology centres and has worked within the life science sector as an international consultant. During his tenure in academia Dr.Brandén was mentored by professor James E. Rothman (Nobel prize winner, 2013) and recruited to several director positions with Columbia University and Yale university. Dr.Brandén has also spent a year in art school and has had international art exhibitions. Dr.Brandén is now working as Science Advisor for a global provider of automated laboratory instruments and solutions in Switzerland

This course is aimed at professionals working with or planning to work with viral vectors either as a gene therapy or as a gene modified cell therapy. Specifically, the course is aimed at those in manufacturing of viral vectors. Gene/Cell Therapy Process Development | Cell Therapy Process Development | Quality Control/Assurance | Regulatory Affairs Professionals | Final Release Testing.

Free First Module and Pricing
  • Module 1 is free to attend for this live online course and is delivered a few weeks before the start date.
  • To enrol onto module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • You will receive a Super Early Bird discount if you purchase the course before module 1.
  • If you decide to purchase the course after module 1, but before the start date you will receive an Early Bird Discount.
  • To sign up to the free first module provide your email address in the form at the top of the page.

Frequently asked questions (FAQs)

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate