Theoretical analysis of excipient concentrations during the final ultrafiltration/diafiltration step of therapeutic antibody

Biotechnology Progress

Volumn 25, Issue 4, 2009, Pages 964-972

  Miao, Fudu ^a   Velayudhan, Ajoy ^a   Dibella, Elsie ^a   Shervin, Jaclyn ^a   Felo, Michael ^a   Teeters, Mark ^a   Alred, Patricia ^a  

^a CENTOCOR INC   (United States)

Author keywords

Excipient; Formulation; Modeling; Monoclonal antibody; Ultrafiltration diafiltration

Indexed keywords

CHARGE INTERACTIONS; CHARGED MOLECULE; CHARGED PROTEINS; DIAFILTRATION; ELECTRICAL POTENTIAL; EXCIPIENT; EXPERIMENTAL STUDIES; FORMULATION; MODELING; POISSON-BOLTZMANN EQUATIONS; PRODUCTION RUN; PROTEIN SOLUTION; RETENTATE; THERAPEUTIC ANTIBODIES; THERAPEUTIC MONOCLONAL ANTIBODIES; ULTRAFILTRATION/DIAFILTRATION; VOLUME EXCLUSION; VOLUME EXCLUSION EFFECTS;

ALCOHOLS; ALLERGIES; BOLTZMANN EQUATION; COMPUTER SIMULATION; MATHEMATICAL MODELS; MERGERS AND ACQUISITIONS; MOLECULES; MONOCLONAL ANTIBODIES; POISSON EQUATION; SUGAR (SUCROSE); SURFACE PLASMON RESONANCE;

CONCENTRATION (PROCESS);

EXCIPIENT; MONOCLONAL ANTIBODY; SORBITOL; SUCROSE;

CHEMISTRY; CONFERENCE PAPER; DRUG THERAPY; FILTRATION; THEORETICAL MODEL; ULTRAFILTRATION;

ANTIBODIES, MONOCLONAL; DRUG THERAPY; EXCIPIENTS; FILTRATION; MODELS, THEORETICAL; SORBITOL; SUCROSE; ULTRAFILTRATION;

EID: 69149087621     PISSN: 87567938     EISSN: None     Source Type: Journal    
DOI: 10.1002/btpr.168     Document Type: Conference Paper

References (30)

1. Zydney AL, Kuriyel R. Protein concentration and buffer exchange. In Desai MA, editor. Downstream Processing of Proteins: Methods and Protocols. Totowa NJ: Humana; 2000.
2. Stoner MR, Fischer N, Nixon L, Buckel S, Benke M, Austin F, Randolph TW, Kendrick BS. Protein-solute interactions affect the outcome of ultrafiltration/diafiltration operations. J Pharm Sci. 2004; 93: 2332-2342.
3. Tanford C. Physical Chemistry of Macromolecules. New York: Wiley; 1961.
4. Lee JC, Timasheff SN. The stabilization of proteins by sucrose. J Biol Chem. 1981; 256: 7193-7201.
5. Arakawa T, Timasheff SN. Stabilization of protein structure by sugars. Biochemistry. 1982; 21: 6536-6544.
6. Back JF, Oakenfull D, Smith MB. Increased thermal stability of proteins in the presence of sugars and polyols. Biochemistry. 1979; 18: 5191-5196.
7. Arakawa T, Kita Y, Carpenter JF. Protein-solvent interactions in pharmaceutical formulations. Pharm Res. 1991; 8: 285-291.
8. Kim Y-S, Jones LS, Dong A, Kendrick BS, Chang BS, Manning MC, Randolph TW, Carpenter JF. Effects of sucrose on conformational equilibria and fluctuations within the native-state ensemble of proteins. Protein Sci. 2003; 12: 1252-1261.
9. Kendrick BS, Chang BS, Arakawa T, Peterson B, Randolph TW, Manning MC, Carpenter JF. Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: Role in restricted conformational mobility and compaction of native state. Proc Natl Acad Sci USA. 1997; 94: 11917-11922.
10. Gerlsma SY. Reversible denaturation of ribonuclease in aqueous solutions as influenced by polyhydric alcohols and some other additives. J Biol Chem. 1968; 243: 957-961.
11. Gerlsma SY. The effects of polyhydric and monohydric alcohols on the heat induced reversible denaturation of chymotrypsinogen A. Eur J Biochem. 1970; 14: 150-153.
12. Sader JE, Chan DYC. Electrical double-layer interaction between charged particles near surfaces and in confined geometries. J Colloid Interface Sci. 1999; 218: 423-432.
13. Ohshima H, Kondo T. Electrostatic interaction of an ion-penetrable sphere with a hard plate: contribution of image interaction. J Colloid Interface Sci. 1993; 157: 504-508.
14. Ohshima H. Electrostatic interaction between two dissimilar spheres: an explicit analytic expression. J Colloid Interface Sci. 1994; 162: 487-495.
15. Ohshima H. Electrostatic interaction between two dissimilar spheres: image-interaction correction to the linear superposition approximation. J Colloid Interface Sci. 1995; 176: 7-16.
16. Ohshima H. Electrostatic interaction between two dissimilar spheres with constant surface charge density. J Colloid Interface Sci. 1995; 170: 432-439.
17. Ohshima H, Healy TW, White L. Accurate analytic expressions for the surface charge density/surface potential relationship and double-layer potential distribution for a spherical colloidal particle. J Colloid Interface Sci. 1982; 90: 17-26.
18. Horn FM, Richtering W, Bergenholtz J, Willenbacher N, Wagner NJ. Hydrodynamic and colloidal interactions in concentrated charge-stabilized polymer dispersions. J Colloid Interface Sci. 2000; 225: 166-178.
19. Carrique F, Arroyo F, Delgado AV. Electrokinetics of concentrated suspensions of spherical colloidal particles with surface conductance, arbitrary zeta potential, and double-layer thickness in static electric fields. J Colloid Interface Sci. 2002; 252: 126-137.
20. Carrique F, Arroyo F, Delgado AV. Electrokinetics of concentrated suspensions of spherical colloidal particles: effect of a dynamic stern layer on electrophoresis and DC conductivity. J Colloid Interface Sci. 2001; 243: 351-361.
21. Ospeck M, Fraden S. Solving the Poisson-Boltzmann equation to obtain interaction energies between confined, like-charged cylinders. J Chem Phys. 1998; 109: 9166-9171.
22. Chan DYC. A simple algorithm for calculating electrical double layer interactions in asymmetric electrolytes-Poisson-Boltzmann theory. J Colloid Interface Sci. 2002; 245: 307-310.
23. McBride A, Kohonen M. The screening length of charge-asymmetric electrolytes: a hypernetted chain calculation. J Chem Phys. 1998; 109: 2423-2428.
24. Verwey EJW, Overbeek J, Th G. Theory of the Stability of Lyophobic Colloids. London: Elsevier; 1948.
25. Moreria LA, Bostrom M, Ninham BW, Biscaia EC, Tavares FW. Effect of the ion-protein dispersion interactions on the protein-surface and protein-protein interactions. J Braz Chem Soc. 2007; 18: 223-230.
26. Hunter RJ. Foundations of Colloid Science. New York: Oxford University; 2001.
27. Ohshima H, Furusawa K. Electrical Phenomena at Interfaces: Fundamentals, Measurements, and Applications, 2nd ed, Vol. 76. New York: Marcel Dekker; 1998.
28. Creighton TE. Proteins: Structures and Molecular Principles. New York: WH. Freeman;1983.
29. Conway JH, Sloane NJA. Sphere Packings, Lattices, and Groups, 2nd ed. New York: Springer-Verlag; 1993.
30. Quillin ML, Mattews BW. Accurate calculation of the density of proteins. Acta Cryst. 2000; 56: 791-794.