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Workshop:
Challenges to standardisation: Test procedures for
cell-based products intended for cell and gene therapy

January, 20th, 2016
9.00h to 16.00h

Auditorium of Biopark I, Josef-Engert-Str. 9, 93053 Regensburg, Germany


Cell-based medical products are offering a novel approach for the treatment of diseases, where conventional medications show only limited effect. However, these innovative therapeutics also constitute a true challenge to scientists, manufacturers and regulatory bodies. While conventional medicines are composed of defined chemical compounds and are manufactured to routine mass production procedures, these new products are based on living cells which neither can be standardized, nor be subjected to mass manufacturing. Thus, established test and approval procedures will not be able to fully address the specific requirements of new, cell-based medicinal products.

A DIN Working Group currently hosts scientific and industry experts to discuss a new standard for testing and approval of cell based products.

Our workshop will give an introduction to the field of cell-based products and present current developments in testing methods and instrumentation.

This workshop is open to all interested parties. Your intended active participation in the standardization community would be highly welcome, but is no prerequisite to attend this meeting. Please feel free to join the discussion if you are interested in the field of cell-based medical products.


Topics:

  • Establishing and validating test procedures within the biological safety evaluation of medicinal products
  • Validation of biological tests – Lessons learnt during an ECVAM project
  • Impact of automation for the quality of cell-based products, and the resulting requirements.
  • Raw materials quality requirements for manufacturing cell-based products: medical grade, pharmaceutical grade, GMP – what are the industry needs?
  • Test kits for Quality Assurance.
  • MACSQuant® Tyto™: A novel method for cell sorting under sterile conditions
  • Presentation of the current DIN standardisation project

Registration:


Venue:

You can find us here: >> Google Maps Link

Reserved parking spaces are available behind Biopark I (at the end of the dead-end road) and in front of Biopark III. A coin is needed to leave the parking space, it will be available in the meeting room.