Sale

(Bio) Analytics of Cell and Gene Therapies

8 & 9 October 2024 | Short Online Course

Original price was: £395.00.Current price is: £316.00.

(2 customer reviews)

2-day live online training 

Be aware of the assays needed to assess pharmacokinetics, immunogenicity and potency for cell and gene therapies

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Course Overview

 

A growing number of cell and gene therapies or ATMPs are entering development. Like other therapeutics they need to be clinically developed with data gathered on pharmacokinetics, immunogenicity and potency to satisfy regulatory safety expectations. However, unlike biopharmaceuticals, ATMPs are a very different challenge and a new way of thinking is required.

 

This training course will provide you with a deep dive insight into how cell and gene therapy products are clinically developed and manufactured. Once completed you will be aware of the types of assays needed to assess pharmacokinetics, immunogenicity and potency. You will also examine the regulatory expectations around assay validation.

Learn more about how we deliver live online training.

Register Early to Save

 

Enrol before 20 September to save 20% (October Course)

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Key Learning Objectives

  • Brief introduction to gene and cell therapies and recently approved products
  • Understand the basics of cell and gene clinical development and manufacturing
  • Improve your understanding of the key assays in the sector
  • Appreciate the major differences between cell and gene therapy (bio)analytics and biopharmaceuticals
  • Understand the current regulatory expectations around cell & gene assay validation
  • Review the latest outlook and future developments

What is Included?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Download the Agenda

 

You can view the agenda below or if you would like to receive a pdf version with all the course information, please complete the form below.

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Course Dates

 

Find out when this course is running so you can plan your training.

8 & 9 October 2024

4-Hour Course Delivered Over 2-Days

Register at the top of the page.

2025 Dates TBC

4-Hour Course Delivered Over 2-Days
Register at the top of the page.

2025 Dates TBC

4-Hour Course Delivered Over 2-Days
Register at the top of the page.

Learn more about the course by toggling through the tabs below (trainer, who should attend?)

 

Course Outline

Course Information

  • The course begins at the time stated below
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1 | Day 1

8 October 2024

150 mins | 1:00 PM UK

Overview of the CGT industry

  • Brief intro to history of gene therapy and recent approvals
  • Viral vectors and their importance in gene therapy
  • Brief intro to history of cell therapy and recent approvals
  • CGT/ATMP manufacturing process and analytics
  • CGT/ATMP clinical development and bioanalytics

Bioanalytical basics and challenges of CGTs

  • Overview of main methodology used to measure PK: flow and PCR
  • Immunogenicity of gene therapies
  • Special focus on pre-existing antibodies to viral vectors
  • Unwanted insertion events of gene therapies and how to monitor
  • Tracking of cellular therapies
  • Regulatory guidance on bioanalytical assays in the CGT space
Session 2 | Day 2

9 October 2024

150 mins | 1:00 PM UK

Analytical basics and challenges of CGTs

  • Product Release assays in the CGT space
  • Special focus: Potency assays and the importance of mode of action
  • The challenges of multiple mode of actions of cellular therapies
  • Regulatory guidance on potency assays in the CGT space

Special focus: CAR T cells

  • The rise of the CAR T cell and the need for future generations
  • Clinical impact of CAR T cells with regards to patients’ safety
  • CAR T cell future trends such as the off the shell CAR T cell
  • Biomarker analysis

Dr. Melody Janssen is an expert in bioanalysis and immunogenicity testing of biopharmaceuticals with in-depth experience as a project manager, trainer and senior expert in biotech/CGT companies. She has worked on numerous biopharmaceutical products and is an expert on all areas of biopharmaceutical development and manufacturing.
Dr. Janssen has extensive experience of the regulatory frameworks (EMA, FDA etc.) for biopharmaceutical development/manufacturing. Ultimately Melody is aware of the many challenges biopharmaceutical companies face when developing a therapeutic product.

 

She is frequently invited to speak at conferences on immunogenicity and bioanalytical testing, where she also leads conference specific workshops and seminars. She has shared her knowledge through trainings for over 10 years focusing on assay validation for bioanalytical, potency and immunogenicity assays.

 

For the last years, Dr. Janssen has been working as a freelancer for projects including non-clinical and clinical immunogenicity assessment, leading various late pre-clinical candidates to FIH, production of vaccines and biologics and teaching bioanalytical method validation workshops.

 

Her educational background is in infectious diseases and immunology, with a PhD in pharmaceutical sciences investigating the effect of protein aggregates on immunogenicity.

 

This course is aimed at all professionals who work with bioassays such as pre-clinical, clinical and manufacturing. The course assumes previous (bio)analytical experience and is perfect for those moving into cell & gene therapies (ATMPs) or looking to do so in the future.

e-learning options

Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.

Email [email protected] for more information.

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.

 

Complete our contact form by following the link. Get in touch.

*

• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training

2 reviews for

(Bio) Analytics of Cell and Gene Therapies

8 & 9 October 2024 | Short Online Course

  1. Educo Life Sciences

    This is a new course – Reviews will be added after the first delivery!

  2. OmniaBio Inc. (verified owner)

    I thoroughly enjoyed the course and the material covered. The trainer’s delivery style was excellent and captured my interest throughout the course. The topics and concepts covered were beneficial for my current role.

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