8:25 am Chairman’s Opening Remarks

8:30 am Panel: The Bigger Picture: The Priorities of iPSC Based Cell Therapy Manufacturing

Synopsis

  • Identifying areas of focus during different developmental stages to ensure successful iPSC production and scale-up
  • Managing operations and mitigating risk to ensure smooth transition through preclinical and clinical phases

Equipping iPSC Expansion Practices to Cater for Scale-Up and Commercialization

9:15 am Controlled iPSC Culture & Banking for Early-Phase Development of Allogeneic NK Cell Therapies

  • Bruno Marques Executive Director, Process & Product Development, Century Therapeutics

Synopsis

  • Limitless expansion of iPSCs allows for the early-phase manufacture of cGMP master cell banks that serve the entire product lifecycle
  • Creation of clinically relevant iPSC banks requires raw material qualification, application of cGMP principles throughout the process, and appropriate testing strategies
  • Gene-edited iPSCs cultured in adherent systems can be differentiated into hematopoietic progenitors and hypo-immune effector cells in a myriad of bioprocessing systems

9:45 am An Autonomous Technology Platform for the Development and Precision Scaling of Regenerative Medicines

Synopsis

  • Integration of artificial intelligence, laser physics, and stem cell biology to automate the traditionally artisanal processes used in IPSC-based cell therapy development
  • Design and development of a closed system for autonomous cell therapy development and production
  • Utilization of an automated workcell to optimize reprogramming & differentiation processes

10:15 am
Morning Refreshment Break & Networking

11:15 am Suspension Culture: Enabling iPSC Manufacture to Produce Cells of High Quantity and Quality

Synopsis

  • Enhancing growth of iPSCs in suspension-based culture to enable large-scale manufacture
  • Achieving consistent and stable iPSCs in suspension culture by using robust iPSC lines and culture techniques
  • Analyzing how current bioreactors and process control strategies can be improved to cater for high scale manufacture

11:45 am Manufacturing of Next-Generation Cellular Immunotherapies using a Novel Induced Pluripotent Stem Cell Platform

Synopsis

  • Outline advantage of iPSC derived platform
  • Discuss some challenges
  • Review potential scale up opportunities

12:15 pm Establish Master iPSC for Targeted Large-Cargo Integration and its Application in Developing Safe and Efficacious iPSC-CAR-iNK Allogeneic Product

Synopsis

  • Allogeneic cell product
  • Safe and efficient gene insertion TARGATT technology
  • Application in iPSC-CAR-iNK cell therapy

12:45 pm
Lunch Break and Networking

1:45 pm Manage the Microenvironment at Larger Scale Suspension Culture to Ensure Consistent Optimal iPSC Growth

  • Yuguo Lei Associate Professor, Penn State University

Synopsis

  • Understanding the importance of managing cell growth microenvironment for larger-scale suspension culture
  • Controlling cluster sizes to guarantee equal access to growth and differentiation factors
  • Managing the increase in culture density during cell expansion to ensure continuous nutrient availability

2:15 pm Overcoming Bioprocess Challenges to Enable Cell Therapy Development and Commercialization

  • Dan Haus Business Development Manager, PBS Biotech

Synopsis

  • Current challenges in developing scalable cell therapy production processes
  • Overcoming challenges using the PBS Biotech Vertical-Wheel™ bioreactor technology
  • Examples of scalable applications utilizing the PBS Biotech Vertical-Wheel™ bioreactor technology

2:45 pm Panel: Designing the ‘Perfect’ Scale-Up Strategy

  • Bruno Marques Executive Director, Process & Product Development, Century Therapeutics
  • Elizabeth Csaszar Senior Director, Manufacturing Sciences, Notch Therapeutics
  • Yuguo Lei Associate Professor, Penn State University
  • Teisha Rowland Principal Scientist, Umoja Biopharma
  • Mark Plavsic Chief Technical Officer, Fate Therapeutics

Synopsis

  • Reflecting on the needs and requirements for future scale-up to prepare an ecosystem fit for purpose
  • Reviewing technology innovations to revolutionize iPSC manufacture in the pursuit for commercialization

3:15 pm Process Development Excellence to De-risk Manufacturing Challenges and Industrialize iPSC based Therapies

Synopsis

  • Introduce some of the current challenges with development of commercially viable iPSC based therapies from a CDMO perspective.
  • Discuss best practices to de-risk the manufacturing and develop commercially viable iPSC derived cell therapies through implementation of innovative technologies with appropriate in process control and monitoring analytical methods.
  • Explore applying bioprocessing best practices to ensure controlled expansion and differentiation of pluripotent stem cells into specialized cells by eliminating open and variable manual unit operations while incorporating comprehensive characterization assays in the process to verify long term stability of the products.

3:25 pm
Afternoon Refreshments and Networking

Optimizing iPSC Product Quality to Ultimately Obtain an Effective and Safe Treatment

4:00 pm Audience Discussion Session: Exploring Methods to Revolutionize iPSC Quality

Synopsis

  • Defining quality attributes to influence analytical development and innovations
  • Detecting variants early to eradicate diverging populations early
  • Utilizing donor selection to enhance iPSC product quality

4:30 pm Increasing Differentiation Efficiency to Reduce Product Variability

Synopsis

  • Appreciating the need to increase differentiation efficiency to accelerate iPSC therapies into the clinic and beyond
  • Establishing the method to eliminate undifferentiated cells and techniques to reduce variability of product quality
  • Growing efficiency of Yamanaka factor-induced differentiation by utilizing H1foo

5:00 pm Consistency and Dependability of Quality Testing for Clinical-Grade Induced Pluripotent Stem Cells

Synopsis

  • To maximize the full potential of human-induced iPSC-based therapies, banks of suitable quality and demonstrable equivalence of iPSC lines are required for the use of different banks as starting materials for Advanced Therapy Medicinal Products (ATMPs) and the comparability of the ATMPs thereafter
  • This requires consistent quality control testing across iPSC manufacturers’ facilities worldwide
  • Here we describe data from an international quality assessment round organized by the Global Alliance of iPSC Therapies (GAiT) specifically undertaken to assess iPSC quality control assays

5:30 pm Close of Conference Day One