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.

Download the Agenda

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

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 in a Short Live Online Course?

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

Course Dates

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

New Courses for 2025

We have two new courses for bioassays and potency assays in 2025. Scroll up to learn more.

Group Discount

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

• To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
• There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
• The full training course is delivered online.
• For live online courses – The dates and times of modules/sessions are subject to change.
• For live online courses – The module/session durations are approximate.

Frequently Asked Questions (FAQs)

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.