iPSC cell line development and manufacture for cell therapies

Thursday 08:00 PDT / 11:00 EDT / 15:00 GMT / 16:00 CET

Sponsor

iPSC cell line development and manufacture for cell therapies

Induced pluripotent stem cells (iPSCs) are poised to play a pivotal role in cell therapy, providing a versatile starting material for generating therapeutic cells and offering the potential for personalized medicine. Their relevance is highlighted by the growing need for timely provision of effective, off-the-shelf cell therapy solutions at a reasonable price point. The topic's timeliness is accentuated by advancements in gene editing, like CRISPR, which allow complex modifications to be introduced into iPSCs, providing differentiated progeny with new functionalities such as immune evasion and improved cell targeting.

A key challenge in iPSC application is the transition from research to clinical use, necessitating scalable manufacturing while maintaining quality and consistency. This includes ensuring genetic stability and developing cost-effective production methods. We will describe the trends in allogeneic cell manufacturing and how these techniques apply to iPSC production.

This presentation will describe the current state of iPSC development and manufacture, and how new allogeneic manufacturing capabilities may be applied to iPSCs. Overcoming the challenges to iPSC manufacturing will revolutionize treatment approaches, ushering in an era of off-the-shelf, effective medicine.

Overview of allogeneic cell therapy manufacturing trends
Consideration for larger scale iPSC manufacturing strategy
Options for iPSC analytics and release testing
Application of gene editing technologies to iPSC-based cell therapies

Rowan Flynn

Principal Scientist at RoslinCT

As a Principal Scientist at RoslinCT, Rowan brings nearly two decades of valuable research and manufacturing expertise in gene and stem cell therapy. He has developed gene editing strategies for academic and industrial partners and has conducted research in motor neuron disease using genetically modified iPSC-derived cell models. Rowan holds a PhD in Molecular Physiology, an MSc in Biotechnology, and a BSc in Microbiology.

Barbara Ressler

VP, Manufacturing Process Sciences at RoslinCT

Barbara has a long history in the cell and gene therapy space, working on process and analytical development for a variety of autologous and allogeneic cell therapies. She has held leadership roles in both development and contract manufacturing organizations. Currently, at RoslinCT Boston, she oversees the process development, analytical development, and manufacturing sciences and technology groups.

Derek Hei

Chief Technology Officer and Scientific Advisor at Clade Therapeutics

Derek has over 30 years of experience developing cell and gene therapies with expertise in process/assay development, manufacturing and QC testing, and regulatory affairs.

Derek has a BS in Chemical Engineering from the University of Wisconsin-Madison, and a PhD in Biochemical Engineering from the University of California, Berkeley. Following his PhD, Derek worked at Genentech and Cerus Corp. before moving back into academia, taking a position at the University of Wisconsin to lead the development of Waisman Biomanufacturing. At Waisman, Derek led several NIH-funded initiatives including the first National Stem Cell Bank, to develop standards for production and testing of human Embryonic Stem Cells (hESCs).

Derek followed the rapidly evolving iPSC field back into industry with roles including VP of Clinical Manufacture, Quality and Regulatory at Fujifilm Cellular Dynamics, Inc., Chief of Manufacturing and Technical Operations at BlueRock Therapeutics, and Senior VP of Cell and Gene Therapy Pre-Clinical and Clinical Manufacturing at Vertex Pharmaceuticals. Derek is currently the Chief Technology Officer for Clade Therapeutics, where he is responsible for overseeing CMC technical operations including derivation of gene-edited iPSC lines, process/analytical method development, and cGMP manufacturing and testing of iPSC-derived cell therapies.

Mark Tomishima

Senior Vice President of Platform Discovery at BlueRock Therapeutics

Mark Tomishima has over two decades of experience in stem cell biology. He was one of the early employees that helped establish and build BlueRock. Mark has now been a BlueRocker for over 6 years and has held positions of increasing responsibility during his tenure. He is now the Senior VP of Platform Discovery and is responsible for the vision and strategy of BlueRock’s platform.

Prior to this, Mark spent over 16 years at Memorial Sloan Kettering. As a postdoc, he worked in the lab of Lorenz Studer, one of BlueRock’s scientific co-founders. He then helped build and direct the Sloan Kettering Institute Stem Cell Research Facility, leading multiple projects over a decade and resulting in over 30 publications and multiple grants. One of the biggest projects for his lab was leading process development, assay development, and ultimately manufacturing of MSK-DA01, a pluripotent stem cell-based cell therapy for Parkinson’s disease. This cell therapy was initially developed by Lorenz Studer’s New York State (NYSTEM) consortium and is now BlueRock’s lead pipeline product.

Jacqueline Barry

Chief Clinical Officer at Cell and Gene Therapy Catapult

Jacqueline Barry is Chief Clinical Officer, responsible for Clinical Adoption activities, at Cell and Gene Therapy Catapult. In this role, she leads the Access Strategy group (a multi-disciplinary team of Nonclinical, Regulatory, Health Economics, & Market Access specialists); the CGT Catapult Edinburgh Centre, and the coordination of the UK Advanced Therapy Treatment Centre Network.

She feels passionately about making advanced therapies available for patients and works closely with industry partners and policy makers on the development of the ecosystems to support the adoption of these therapies.

Kevin Bruce

Chief Technology and Strategy Officer at RoslinCT

Kevin is the Chief Technology and Strategy Officer of RoslinCT, responsible for developing and enhancing the company’s services and capabilities by leading the technology vision and strategy.Kevin has spent more than 20 years working within the biotech industry, with a focus on cell therapy development and manufacturing, specifically with pluripotent stem cells. Before joining RoslinCT as a Chief Operating Officer (COO), Kevin held positions in Operations, Quality, R&D, and commercial development.

He has been in the Roslin family for over 16 years and has played a key role in the development of Roslin Cells’ clinical-grade pluripotent cell lines and GMP translation and manufacture of cell therapies for both pre-clinical and clinical development. More recently, as COO at Censo Biotechnologies, he established the operational capability for the European Bank for Induced Pluripotent Stem Cells and was responsible for Censo’s stem cell generation, genome editing, and assay development operations for drug discovery.

Pete Tonge

Senior Director, Cell Therapy Engineering at BitBio

Pete is senior director of Cell Therapy Engineering at bit.bio, where he is responsible for derivation of gene engineered iPSC lines for cell therapy. Pete has over 20 years of experience in stem cell research. He completed a PhD at the University of Sheffield (UK) and postdoctoral research at the Lunenfled-Tanenbaum Institute (Toronto) studying somatic cell reprogramming to iPSCs and transgenics. Pete continued to follow his passion for stem cells and regenerative medicine with positions at Centre Commercialisation Regenerative medicine (CCRM, Toronto) and BlueRock Therapeutics, where he led the establishment of clinical-grade iPSC platform.

Dirk Boehm

VP Cell and Gene Therapy - CMC & Industrialization at Bayer Pharmaceuticals

As the VP of Cell and Gene Therapy at Bayer Pharmaceuticals, Dirk leads and coaches a cross-functional team responsible for process development, quality, manufacturing, and regulatory aspects of cell and gene therapy products. He has over 20 years of experience in international biotech and pharma manufacturing settings, with a strong track record of delivering excellent results efficiently and reliably to high quality standards.