ISCT 2019

Melbourne, Australia | May 29, 2019–Jun 01, 2019


Visit booths #48/50 at ISCT 2019 to learn more about our industry-leading cell culture media solutions designed expressly for cell therapy applications.

Discover how the expanding PRIME-XV portfolio of cGMP media aimed to support the large-scale expansion of clinical-grade cells—including chemically-defined media (CDM) for immune cells (T and DC), and xeno-free, serum-free (XSFM) for stem cells—can support your laboratory.

FUJIFILM Irvine Scientific will be participating in the following product theatre and discussion:

Product Theatre:
Friday, May 31, 2019
1:15–1:30 PM
Global Showcase Stage

Developing an Off-The-Shelf Cell Therapy for ACLF and NASH using PRIME-XV MSC XSFM media

Presented by Jef Pinxteren
PhD, VP of Operations, Promethera Biosciences

Panel Discussion:
Friday, May 31, 2019
3:45–5:00 PM
Room 219

Strategies for Commercialization Track 5 – Keeping manufacturing consistent for global expansion
Developing a robust manufacturing process for both autologous and allogeneic therapies requires reliable access to high quality material, all throughout the manufacturing process. As the therapies transition to clinical trials and scale up for commercial manufacturing, the requirements of the source material become even more critical. For autologous therapies, this means maintaining consistency and standardization the materials used at each of the clinical sites and establishing a robust method to maintain the quality for downstream processing. As allogeneic therapies transition to multiregional clinical trials, navigating the potential regulatory barriers for access and use of the starting and in process material presents its own set of challenges. It is important to understand as early as possible the quality and level of compliance (e.g. cGMP) required globally. Inconsistencies in the quality and availability of the source material could result in significant delays to clinical and commercial manufacturing and ultimately patient access, regionally and globally.

Participating from FUJIFILM Irvine Scientific:
Marlin Frechette Sr. Director, Quality Systems/Regulatory Affairs & Compliance Officer

 

Products on Display:


Conference Location:
Melbourne Convention and Exhibition Centre