Sheffield DTC 2013.pdf (1.28 MB)
Quantification of variation in biological input materials and its effect on clinical outcome and manufacture
conference contributionposted on 2013-10-07, 13:07 authored by Jamie Thurman-Newell, Jon PetzingJon Petzing, David Williams
Using blood and blood-based products as a case study, this project will investigate and seek to manage biological input variation from a processing perspective by relating this to clinical outcome (i.e. patient benefit) and exploring the concerns due to input variation when manufacturing a biological therapeutic at multiple sites. • Hematopoietic stem cell transplants are used to treat blood-based cancer and immunological deficiency • Over 130,000 transplants were carried out in Europe between 1990 and 2000 • The living cell is the product, introducing more complexity and sensitivity than found in pharmaceuticals • Humans are the source of the raw material, and we are inherently variable • Variation affects the cost, the safety of the therapeutic and the efficacy of the treatment
Funding for this work is provided by an EPSRC grant as part of the Doctoral Training Centre for Regenerative Medicine
- Mechanical, Electrical and Manufacturing Engineering
CitationTHURMAN-NEWELL, J.A., PETZING, J.A. and WILLIAMS, D.J., 2013. Quantification of variation in biological input materials and its effect on clinical outcome and manufacture. Presented at the Fourth Doctoral Training Centre Joint Conference 2013, 12th July 2013, Sheffield University.
- VoR (Version of Record)
NotesThis is a conference paper.