Cell and Gene Therapy Symposium: Challenges of Analyzing ATMPs

Now available On-Demand!
ATMP landing page

Bio-Techne looks forward to welcoming you to this exciting virtual event to discuss the latest topics within the cell & gene therapy community. The theme for this 2nd virtual symposium is a discussion around the “Challenges of analyzing ATMPs”.

Quality control of advanced therapy medicinal products (ATMPs - therapies based on genes, tissues or cells) is complex. Due to the nature of the therapy, there is often only a narrow window of time to determine if a product is safe to provide to a patient. You must also consider challenges while scaling these therapies up when increasing the numbers of patients.

During our 1st virtual symposium we posed a question to our audience of “What are your biggest challenges around quality control?” Key answers included: automation, time, data integrity, robustness, and training – some of which we will be covering during this event.

At Bio-Teche we aim to keep everyone connected, communicating and collaborating to advance the cell and gene therapy research and beyond from bench to clinic. We are looking to bring everyone together to discuss these latest developments and technologies.

We have created an exciting agenda with 6 keynote speakers and a Q&A session.

Join us to find out from leading scientists how they are pushing the boundaries of cell & gene therapy research.


Introduction - Lindsay Clarke
Protein Simple - Chris Heger
CCRM - Steven Keizer
PaceLabs - Benjamin Buer 
GAiT - Stephen Sullivan 
HCAT - David Smith
Synthace - Moiz Ebrahimjee 
4:05-4:45pm Q&A


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Lindsey Clarke, Ph.D.
Head of Cell and Gene Therapy, EMEA, Bio-Techne
Symposium Host

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Chris Heger, Ph.D.
Senior Manager, Applications Science, Bio-Techne
“Overcoming Analytical Challenges in the Development and Characterization of ATMPs"

Advanced therapies, including cell and gene therapies, are continuing to experience challenges associated with development and characterization, as ATMPs become increasingly more complex. Thus, analytical tools that can help streamline one or multiple stages of development and characterization of ATMPs are critical to improving the ‘time to patient’ outlook.
In this webinar, we’ll discuss how analytical instrumentation from Bio-Techne can be used to overcome these challenges, in the development and characterization of this rapidly expanding class of therapeutics.

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Steven Keizer
Director, Quality, CCRM
“Developing Analytics for ATMPs”

Brief overview of the challenges within the ATMP development space with respect to the analytical methods intended to provide the feedback into the developing manufacturing processes arising in the living therapies world. This overview will mention the regulatory framework followed by the interpretation of the regulations from a CDMO point of view.

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Benjamin Buer, Ph.D.
Associate Director of Pharmaceutical Development, Pace Analytical Life Sciences, LLC
“Characterization of Viral-Based Gene Therapies to Ensure Chemical and Physical Stability”

The size and higher order structure of viral particles creates a unique challenge in their use as therapeutics for establishing quality, purity, identity and potency. Discriminating analytical and biophysical tools are key to fully characterizing and understanding routes of protein capsid degradation that are unique to each drug substance on the path to producing a stable gene therapy and meeting rigorous safety guidelines. In this symposium, we will discuss analytical and biophysical strategy to characterize viral vector-based gene therapies and ensure stability of viral capsid proteins in solution.

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Stephen Sullivan Ph.D. MBA

Global Alliance for iPSC Therapies
“Quality & Standards for Clinical-Grade Induced Pluripotent Stem Cells”

Use of clinical-grade human induced pluripotent stem cell (iPSC) lines as a starting material for the generation of cellular therapeutics requires demonstration of comparability of lines derived from different individuals and in different facilities. This requires agreement on the critical quality attributes of such lines and the assays that should be used. 
Concentrating on those issues more relevant to iPSCs, this seminar summarizes recommendations for the minimum dataset required to consider an iPSC line of clinical grade and describes efforts to test for quality in a consistent and indicative manner across an international haplo-banking network.


David Smith, MEng, Ph.D.
Director of Research and Development, Hitachi Chemical Advanced Therapeutics Solutions
“CDMO Perspective on the Challenges and Solutions Associated With the Quality Control of Cell Therapy Products”

We will take a dive into how the quality control labs look today, before taking a look into the crystal ball to identify a future state. By understanding the needs of the future manufacturing scenarios, of cell and gene therapy products, we can predict the quality control requirements to include cost drivers, footprint, equipment and above all accuracy of our safety measurements.
With these two viewpoints in hand we will identify the challenges of moving from today’s quality control laboratory into tomorrows to ensure we can safely, accurately, timely and reproducibly measure a products attribute. After identification, it will be critical to prioritize and understand the rationales to move into Quality Control 2.0.

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Moiz Ebrahimjee
Cell and Gene Therapy Business Development Manager, Synthace Limited
"Computer-Aided Biology: Intelligent Automation for Accelerated Analytics"

Optimised analytical processes and techniques are critical to the robustness of our product and overall departmental efficiency. We are all constrained by time and resources.
This talk will focus on how we can address these challenges with flexible automation of both physical and digital activities. We will introduce the prospect of computer aided biology as the backbone to process development.