Quantification of variation in biological input materials and its effect on clinical outcome and manufacture Jamie Thurman-Newell Jon Petzing David Williams 2134/13278 https://repository.lboro.ac.uk/articles/conference_contribution/Quantification_of_variation_in_biological_input_materials_and_its_effect_on_clinical_outcome_and_manufacture/9556916 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 2013-10-07 13:07:30 untagged Mechanical Engineering not elsewhere classified