Cell Therapy Insights - Houston

September 18, 2018

Learn more about Enterprise Solutions for Cell Therapy

 

 

  • Event details
  • Event agenda
  • Presenters
  • Cell Therapy web page
  • Flyer

Date: Tuesday, September 18, 2018

Time: 10:00 AM-3:00 PM

Location

Third Coast Restaurant & Conference Center

Texas Medical Center

6550 Bertner Ave, 6th Floor

Houston, TX 77030

Room 1

9:30 AM – 10:00 AM: Breakfast and Introduction

10:00 AM – 10:45 AM: Smart, Closed & Connected Solutions for Cell Therapy Manufacturing

10:45 AM – 11:30 AM: Cell Therapy Processing on Sepax C-Pro and Sefia Systems

11:30 AM – 12:00 PM: Product Showcase

12:00 PM – 12:45 PM:  Lunch and Presentation; Challenges with Cryopreservation

12:45 PM – 1:00 PM: Break

1:00 PM – 1:30 PM: Product Showcase

1:30 PM – 2:30 PM: Round Table Discussion

John Morris

John Morris

Ph.D.  - CEO, Asymptote, Ltd, A GE Healthcare Company
John Morris is the CEO of Asymptote, Ltd. that makes pioneering technologies that challenge standard cell cryopreservation and thawing practices and support cGMP. In April 2017 the company was acquired by GE Healthcare. John did his PhD on the cryobiology of T cells within the MRC division of Cryobiology at the Clinical Research Centre, Harrow, in the 1970’s. Since then he has published over 100 papers in peer reviewed journals on the science of cryobiology. After gaining is PhD he worked for 8 years as a research scientist with the Natural Environment Research Council in Cambridge UK, where he was responsible for the establishment of the first cryopreserved biobank of algae and research on the basic mechanisms of freezing injury and tolerance in extreme environments, such as polar and alpine.

Phil Vanek

Philip G. Vanek, Ph.D.

GM Cell Therapy Growth Strategy, GE Healthcare 

Phil is General Manager of GE Healthcare’s Cell Therapy Technologies business strategy.  At GE, Phil’s team built the strategy that led to investments including BridGE@CCRM and Vineti Networks, as well as acquisitions of Biosafe in Switzerland, and Asymptote LTD in the UK. Prior to joining GE, Phil was Head of Innovation for Lonza’s Pharmaceutical division, leading a group of research scientists, process development engineers, and commercial strategists to drive new technology initiatives focused on cell, protein, and viral therapeutic manufacturing. Phil’s career has included a number of senior innovation, business and market development roles at Becton Dickinson (BD), Invitrogen, and Life Technologies, as well as two start-up biotechnology companies in the Washington, DC area. Phil received his Ph.D. in Biochemistry and Molecular Biology from Georgetown University Medical Center and subsequently held an IRTA fellowship at the National Cancer Institute in the Laboratory of Molecular Oncology and the Hollings Cancer Center in Charleston, South Carolina. Phil is an active board member of the Alliance for Regenerative Medicine and the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto.  Phil has published a number of industry position pieces and serves on the Editorial Board of Cell and Gene Therapy Insights.
 

Andres Ramirez

Andres Ramirez

Senior Field Applications Scientist

Andres holds a Biomedical Engineering degree from Texas A&M University. His areas of expertise began in the medical device industry investigating clinical cases and submitting regulatory reports to the FDA. Andres’s interests for regulatory affairs led him to Biosafe where he held multiple roles managing quality, service, and regulatory submissions to the FDA. Continuous developments in the Biosafe technology further increased Andres's enthusiasm as he assumed a role in customizing and deploying solutions for cell therapy prospects. In 2016, GE Healthcare integrated the Biosafe group as part of an advance to cell therapy.  Andres’s expertise in various fields of the medical device industry has made him a valuable asset for GE Cell Therapy business. Andres is now a Senior Field Application Scientist who focuses in providing and adapting solutions to the evolving cell therapy market.

 

 

Having trouble registering? Please contact 
Michael Hammerman, 
Cell Therapy Sales Specialist, to register today.

 

 

Abstracts

 

Smart, Closed & Connected Colutions for Cell Therapy Manufacturing

As patient specific, autologous cell therapies are in advanced clinical trial phases and are embarking on commercialization, with recent approvals, there continues to be a need to have a robust, closed, automated and scalable manufacturing solution that can accommodate the processing many patient samples in this growing patient population. What will be required is a means to process patient material in a fashion which maximizes the efficiency of the processing workflow for time and cost while meeting quality and regulatory requirements. This approach should retain the fundamental principles of preventing contamination, patient sample mixing, loss of identity or other events which interfere with the physical properties and integrity of the patient sample and final product. Our work at GE Healthcare Cell Therapy encompasses developing solutions that address what a manufacturing infrastructure needs to look like to take the above aspects into consideration and methodologies of how to achieve this infrastructure, through a closed, automated and digitally connected solution.

 

 

 

Challenges with Cryopreservation

Asymptote Ltd, now part of GE Healthcare, is developing next generation equipment and consumables for cryopreservation. This talk will describe the development of a validated liquid nitrogen free end-to-end supply chain from manufacturing to patient delivery, applicable for both autologous and allogeneic ATMP treatments. Currently the company has developed a range of controlled rate freezers which are suitable for the cryopreservation of cells in many formats (vials, bags, multiwall plates etc.) and “dry” thawing equipment for bags and vials. Other elements of the cold chain (shipping and long-term storage) are in development. All the equipment is monitored and tracked using my.Cryochain which is the only platform developed specifically to control the cryochain for cellular therapies. All the products integrate with my.Cryochain to standardize and audit remote processes from any web-browser.

 

In addition to cell therapies, the equipment has significant advantages to cryopreservation in bioprocessing (working cell banks and master cell banks, lentivirus production) and research (Transgenic mouse embryos, IPS derived cells, adherent cells in multiwell plates and organoids).

 

 

 

Cell Therapy Processing on Sepax C-Pro and Sefia Systems

The Sepax C-Pro and Sefia Cell Processing Systems are both automated and functionally-closed technologies developed for cell processing when manufacturing cell therapy products. In this presentation, we will explore the technical capabilities and applications for each instrument and describe some of the features and benefits which make them key assets to any workflow. Some of the key attributes of the Sepax C-Pro system include its versatility in completing combinations of multiple processing steps, including and not limited to enrichment, isolation, washing, concentration, dilution, and splitting. Meanwhile, the Sefia Cell Processing system combines large scale processing steps, including and not limited to isolation, washing, concentration and final formulation under optional regulated temperatures and mixing. Each platform also combines exclusively with dedicated software protocols and cell processing kits to process cellular products.