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

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.

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.

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.

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.

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.