Webinar: The Manufacturing Challenges Facing Cell & Gene Therapy
PCT Team | September 16, 2019
On Thursday, September 19, 2019, Dr. Robert Preti will join a panel of other cell and gene therapy industry luminaries to highlight the challenges that the industry is facing, as well as some strategies to overcome them.
Who’s Joining the Cell & Gene Therapy Webinar?
This webinar, which is being hosted by the Alliance for Regenerative Medicine (ARM), features a bevy of cell and gene therapy experts, including:
Amanda Micklus, Principal Analyst, Datamonitor Healthcare, Informa Pharma Intelligence
Micheal Lehmicke, Director, Science & Industry Affairs, ARM
David DiGuisto,PhD, Chief Technical Officer, Semma Therapeutics
Michelle Berg, President, GMP Nucleic Acids Business Unit, Aldevron
These cell and gene therapy veterans will join Dr. Preti in a roundtable discussion to offer their insights and personal experiences as cell and gene therapy veterans.
What Will the Webinar Cover?
The webinar plans to highlight the challenges faced by cell therapy manufacturers and some strategies for overcoming these difficulties. Topics include:
Transitioning to Commercial Scale Manufacturing. When moving from smaller or pilot-program production levels to the levels demanded by commercialization, many manufacturers struggle to make the transition. This is especially pronounced with patient-specific cell therapy products.
Whether to Use In-House or Outsourced Manufacturing. Manufacturers of cell therapies have to decide whether to build internal manufacturing capacity (at great risk to themselves) or to leverage existing third-party manufacturing facilities (and overcoming the challenges of performing a technology transfer).
Making Deals. Over the last few years, there have been many high-profile mergers in the cell and gene therapy industry. Dr. Preti and Michelle Berg will be leading a discussion about what drives these deals and whether more will happen in the future.
New Manufacturing Methodologies for Cell Therapy. The panelists will discuss the ways cell therapy manufacturers are trying to increase quality, scalability, and safety while minimizing the cost of goods for therapeutic products.
Standards for New Cell/Gene Therapy Products. While the U.S. FDA recommends manufacturers to rely more on standards to ease development and approval processes, some manufacturers have noted that achieving agreement upon standards has been a slow process. Michael Lehmicke will highlight ARM’s perspective on this issue.
Logistical Challenges for Cell Therapy Manufacturing. Because of the limited shelf life of both starting materials and modified cells, limited cell collection capabilities, and potential variability of starting materials, logistics remains a massive challenge for cell therapy products. Dr. DiGiusto and Dr. Preti will discuss these logistical challenges and how to deal with them.
Viral Vector Production. In the realm of gene therapy, viral vector production remains a challenge. In this portion of the webinar, Michelle Berg and Michael Lehmicke will discuss the use of next-generational materials and non-viral delivery methods as alternatives to viral vector production.