Facing challenges on CGT method validation controls? Read our guide

1 August 2023
Advanced Therapy Medicinal Products
Kathleen O’Hagan
Global Change Facilitator

The novelty and rapid expansion in cell and gene therapy (CGT) products have meant that biomanufacturers are often met with unclear requirements from health authorities.

This lack of guidance presents industry with some specific challenges when it comes to analytical method validation and selecting appropriate controls. These challenges include: ​

  • What are considered appropriate controls and standards?
  • What alternative materials can be used when materials are scarce?
  • If processes change, is the reference standard still relevant?

Guiding you through these challenges is our new publication, CGT method validation controls – current practices and considerations​. This reviews the current CGT regulatory landscape focusing on release assays and controls and highlights any gaps. It also summarizes the analytical controls that can be used to establish release methods for CGT products and discusses bridging studies considerations for analytical controls to be used when processes change.

“With the evolution of analytical methods and regulatory expectations tailored to CGT products, challenges exist when identifying analytical controls for dealing with limited regulatory guidance and materials,” said Yan Zhi, Director, Cell & Gene Therapy Product Owner at CSL Behring. “This information from experts across biopharma, biotech, and CDMOs indicates, in a single location, the major guidance and advice on what is considered appropriate controls and what alternatives can be used when materials are scarce.”

A valuable reference tool

Written as an easily digestible set of slides, it gives you a valuable reference tool containing all the guidance in one place. If you have an analytical package ready to submit, it will help you to understand and evaluate any gaps in your package and help you prepare talking points before meeting with a regulator. The slides also contain the results of a comprehensive method validation controls benchmarking survey.

“As an industry first, this slide deck provides a typical analytical testing strategy that considers appropriate assay controls for generic CGT products, based on current guidance and industry practice,” added Zhi. “It will be extremely useful for new analysts entering the CGT space and more experienced teams who can use it to undertake a gap analysis of their analytical package.”

The team’s main goal  is to align practice and, ultimately, create some harmonization of the controls needed, but a secondary aim is to stimulate debate with external organizations and influence regulators.

We are still in the infancy of CGT regulatory requirements being established due to the uniqueness of each product. Health authority engagement at each phase is still a critical requirement to get early buy-in on your company’s proposed strategy that is specifically tailored to your CGT product. Our slides will be a great reference tool for when you are developing your methods and looking for suggestions on the controls you need.

Webinar: CGT Method Validation Controls – Current practices and considerations

On 12 September 2023, we bring you a webinar that will focus on identifying the analytical controls for CGT when dealing with limited regulatory guidance and materials. ​It will start with a brief introduction to the paper, followed by a panel discussion. You can register for the webinar here and if you have any questions for the panelists, please email these questions to

For more information on the paper and the webinar, contact Kathleen O’Hagan, Global Change Facilitator, at

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