Diana Colleluori at Bluebird Bio will discuss, â€śQuality Control Considerations for Commercialization of Autologous Cell Productsâ€ť at 3rd Cell & Gene Therapy
Online PR News – 24-June-2016 – Boston – Diana Colleluori, Senior Director of Quality Control at Bluebird Bio, will give a presentation on â€śQuality Control Considerations for Commercialization of Autologous Cell Productsâ€ť at GTCbioâ€™s 3rd Cell & Gene Therapy Conference to be held on September 12-13, 2016 in Boston, MA.
Quality expectations are not based on the speed of the approval process, thus leading to quality control challenges in expedited product development cycles as exists for gene therapies. Most often, there is less product information and limited data available at the time of marketing submissions. Sponsors are faced with overcoming many quality challenges, including analytical method development, methods validation, and establishment of product stability. The evolving strategies within quality control for rapid commercialization of autologous cell products will be discussed, along with several case studies.
Treatment of disease using cell and gene therapy is now a reality. With emerging technologies and new clinical trials being developed and launched at a growing rate, this meeting will discuss the evolving regulatory challenges and pre-clinical requirements, emerging technologies, the development and applications of cell and gene therapy, as well as business models and commercial milestones. The conference will bring together an exciting balance of industry and academia, so that delegates have the unique opportunity to network with colleagues and gain fresh perspective on the various research.
This conference is also part of our larger Modern Drug Discovery & Development Summit, which consists of five additional co-located conferences:
3rd Cell & Gene Therapy
11th Drug Design & Medicinal Chemistry
Drug Delivery Controlled Releases
7th Non-Coding RNA & RNAi Therapeutics
4th GPCR in Drug Discovery
Cell Culture & Cell Line Development
For more information, please visit website: www.gtcbio.com/cellandgenetherapy
635 W. Foothill Blvd
Monrovia, CA 91016
Phone: (626) 256-6405
Fax: (626) 466-4433