2013 EU Cellular medicines workshop

Bioproduction. It takes one to serve another

Date:	Tuesday 5th of November, 2013
Location:	Life Technologies office Saint Aubin Immeuble Discovery - batiment 7, Parc Technologique, Route de l'Orme des Merisiers, 91190, Saint Aubin
Register:	Start your registration now. Simply send an email confirming your participation and contact details to Geoffroy.malherbe@lifetech.com.

09:45	Welcome and coffee
10:00	Workshop introduction—Geoffroy Malherbe,Pharma analytics key account manager, France
10:15	Process development in cell therapy manufacturing—Brian Newsom,Global business development leader, cellular medicine Over the last 20 years Cell Therapy has seen its share of success and tragedy and is just beginning to claim its place as the next paradigm in medicine. A significant obstacle to better clinical outcomes, however, is the difficulty in implement process changes that can bring new raw materials or technologies to bear within the manufacturing scenario; changes that can create more potent cells, reduce COGS, and remove variability. During this talk we will focus on ways to streamline manufacturing and make process changes. We will start with some of the hazards in the typical manufacturing process from supply chain issues, regulatory compliance, and product variability; then we will discuss ways to minimie those dangers while creating more robust and effective therapies. The discussion will showcase some of Life Technologies' process development successes and share some service capabilities and product options that will allow you to bring these same resources to bear for your cell therapy development.
11:00	Key technologies for stem cell research—Christoph Hoefer,Senior business development manager, stem cells Human stem cells have the potential become instrumental in the treatment of numerous diseases and rapid progress is being made in light of future clinical applications. Use of cGMP compliant products from the onset ensures high product quality, lot-to-lot consistency, manufacturing reliability and traceability, as well as facilitating the transition from research to the clinic. Furthermore, stem cell research has changed quickly with the arrival of the creation of iPSCs in 2007. Some of the major issues facing researchers today include reprogramming their cells of interest, maintenance and selection of their iPSCs post-reprogramming, reproducible methods for the characteriation and the expansion of these iPSC. I will offer a review of our technology offerings to support these critical steps and discuss key resources to address challenges such as the clinical grade expansion of human stem cells under serum- and xeno-free conditions.
12:00	Lunch
13:15	Addressing the challenges of real-time mycoplasma release testing in cellular medicine—Berengere Francois, Field application specialist pharma analytics EMEA The shelf life of most cellular medicines raises major concerns about the turn-around time of either traditional or sub-contracted nucleic acid techniques mycoplasma testing. Those modes of testing also add to the overall high cost per patient of many regenerative therapies. The MycoSEQ™ assay has been the favoured option to address this challenge in the regenerative medicines area since many years already. However validation details and regulatory acceptance were, until recently, still somewhat open questions. The 2013 first EMA approval of an NAT-released ATMP for commercialiation throughout Europe opens a new opportunity for the cellular medicines community. How your organiation could benefit from this key regulatory breakthrough will be discussed in this section.
14:00	Coffee
14:15	Your cells may not be the ones you think they are—Laure Bagait,Field application specialist human identification Confirm the identity of your samples when it matters most. Over the past years there has been a progressive increase in the use of cells as models, substrates and tools for both basic research and industrial applications. The rapid growth in areas such as cell biology, genomics and proteomics has triggered a remarkable increase in cell culture activities and cell manipulations. Validation of the final material became essential in order to insure that it is genetically identical to the starting material and verify that it contains no contaminating cells from a different human source. The STR loci used in AuthentiFiler™ can provide this genetic confirmation of cell identity. It is intended for use in human cell identification in various applications requiring cell discrimination and identity confirmation.
15:00	Cell therapy systems (CTS™) quality reagents for translational researchers—Sandy Kuligowski, Senior product development manager, cell therapy Researchers in the Cell Therapy space need access to tools and reagents that allow them to transition seamlessly from research into clinical applications. Current regulatory guidelines are not “black-and-white”, vary across regions and are evolving as the field emerges creating added complexity. During this talk, we will focus on the CTS™ product line designed to reduce the customers' burden in identifying and qualifying reagents as they prepare to move their concepts into the clinic. We will discuss the features of the CTS™ product line for Cell Therapy applications including unified documentation and clear labeling for “For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products”. These products, combined with our regulatory compliance expertise, provide invaluable support to Cell Therapy researchers in achieving a successful transition to the clinic and ultimately commercialied therapies. Key reagents for a smooth move from research to clinic.
15:30	Round table wrap up
16:00	Close