Boston, MA, March 17, 2016 --(PR.com
)-- Sheng Lin‐Gibson, Deputy Chief of the National Institute of Standards and Technology of the Federal Agency, will give a presentation on, “Addressing Cell Characterization Measurement Challenges for Cell Therapy Products” at GTCbio’s Stem Cell Summit 2016 to be held on April 25-27, 2016 in Boston, MA.
Cell therapy products (CTPs) are becoming commercially viable due to recent discoveries, technological advances, and increased investments. The industry must address key manufacturing challenges, including understanding and establishing Critical Quality Attributes (CQA) for candidate products. This talk will describe recent standardization efforts (including those within ISO) to define and assure CQA measurements. Defining CQAs (i.e., identity, quantity, purity/impurity, sterility, viability, stability, and biological activity or potency) for CTPs is challenging due to a lack of understanding in the mechanism of action (defining what is important to measure), dynamic and heterogeneous nature of the cell-based products (biological variability), and measurement variability. This effort includes the development of a framework for a common understanding of quality attributes for CTPs that is necessary to facilitate further discussions on how best to identify and address measurement needs and challenges. Sheng Link-Gibson will show the importance of cell quantity measurements (i.e., cell counting methods) associated with clearly defined cell (sub)populations and will further discuss the utility of this framework by breaking down the viability measurement and suggest strategies for achieving measurement assurance for cell assays.
Sheng Lin-Gibson will join other top experts to discuss recent developments in pre-clinical and clinical trials of stem cell therapy, regenerative medicine and frontiers in tissue engineering, cancer stem cells, immunotherapy, stem cell reprogramming, regulatory policies regarding stem cell research, manufacturing and scalable processes. Challenges and potential strategies for overcoming these challenges will also be addressed. What categories of companies are currently commercially viable? How are they being funded? What kind of strategic relationships are available within the industry? How do you create sustainable business models?
GTCbio’s Stem Cell Summit 2016 includes two back-to-back conferences:
Conference 1: 13th Stem Cell Research & Regenerative Medicine
Conference 2: 5th Stem Cell Product Development & Commercialization
For more information, please visit website: www.gtcbio.com/stemcellsummit
635 W. Foothill Blvd
Monrovia, CA 91016
Phone: (626) 256-6405
Fax: (626) 466-4433