Sheffield DTC 2013.pdf (1.28 MB)

Quantification of variation in biological input materials and its effect on clinical outcome and manufacture

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conference contribution
posted on 07.10.2013, 13:07 by Jamie Thurman-Newell, Jon 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[1] • 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

Funding for this work is provided by an EPSRC grant as part of the Doctoral Training Centre for Regenerative Medicine

History

School

  • Mechanical, Electrical and Manufacturing Engineering

Citation

THURMAN-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.

Publisher

EPSRC

Version

VoR (Version of Record)

Publication date

2013

Notes

This is a conference paper.

Language

en

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Keywords

Exports