Title page for ETD etd-41298-161018


Type of Document Major Paper
Author Elhadj, Selim
Author's Email Address elhadj@vt.edu
URN etd-41298-161018
Title Economic Feasibility of the Recovery of Therapeutic Proteins From the Milk of Transgenic Livestock
Degree Master of Engineering
Department Chemical Engineering
Advisory Committee
Advisor Name Title
Davis, Richey M.
Williams, Kimberly Forsten
Velander, William H. Committee Chair
Keywords
  • human serum albumin
  • human protein C
  • factor VIII
  • therapeutic protein
  • manufacturing cost
  • recovery
  • milk
  • transgenic
Date of Defense 1998-05-05
Availability unrestricted
Abstract
The recovery of pharmaceuticals from blood plasma is often expensive, limited,

and is subject to contamination. The objective of this feasibility study is to

present recovery designs and the most significant parameters affecting

manufacturing costs of human Serum Albumin (hSA), human Protein C (hPC), and

Factor VIII (FVIII) from the milk of transgenic livestock. All the processes

presented are based on chromatography columns to achieve separation. The

sensitivity of the manufacturing cost of the protein to various parameters

are illustrated graphically and discussed, along with the cost distribution

percentages for each type of process. It was found that manufacturing costs

decrease with superficial velocity, expression levels, column yields,

column capacities, and scale of production increases with all other parameters

remaining constant. However the estimated cost decreases tend to level out at

higher values of the parameters. Finally a judicious choice of

separation scheme, such as Fall-Through (FT) versus Direct Adsorption (DA) for

hSA production, can decrease the protein cost by as much as 38%, due to savings

from wash and elution buffers. The costs associated with the production of hSA

(DA process), hSA (FT process), hPC, and FVIII are 3.56, 2.20, 129, and 11,780

$/gr respectively. By means of the optimization of manufacturing parameters to

reduce costs, key areas of emphasis for process development were identified.

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