On developing a process for conducting extractable-leachable assessment of components used for storage of biopharmaceuticals

Journal of Pharmaceutical Sciences

Volumn 99, Issue 5, 2010, Pages 2209-2218

  Wakankar, Aditya A ^a   Wang, Y John ^a   Canova Davis, Eleanor ^a   Ma, Stacey ^a   Schmalzing, Dieter ^a   Grieco, Josh ^a   Milby, Terry ^a   Reynolds, Theresa ^a   Mazzarella, Kellen ^a   Hoff, Ed ^a   Gomez, Stephen ^a   Martin Moe, Sherry ^a  

^a GENENTECH INC   (United States)

Author keywords

Drug compatibility; Extractables; Health based risk assessment; Leachables; Pharmaceutical development; Protein adducts

Indexed keywords

3 (3,5 DI TERT BUTYL 4 HYDROXYPHENYL)PROPIONIC ACID OCTADECYL ESTER; BOVINE SERUM ALBUMIN; BUTYLCRESOL; CD86 ANTIGEN; CONCANAVALIN A; EXTRACTABLE; INORGANIC COMPOUND; LEACHABLE; LYSOZYME; OLEIC ACID; PLASTICIZER; POLYSORBATE 80; POLYVINYLCHLORIDE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT VASCULOTROPIN; RIBONUCLEASE A; SILICONE OIL; TUNGSTEN; UNCLASSIFIED DRUG; VALNOCTAMIDE;

ANTIGEN EXPRESSION; CELL ACTIVATION; CHRONIC KIDNEY DISEASE; DENDRITIC CELL; DOCUMENTATION; DRUG CONTAMINATION; DRUG DELIVERY SYSTEM; DRUG FORMULARY; DRUG IMPURITY; DRUG ISOLATION; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; EXTRACTION; FOOD AND DRUG ADMINISTRATION; FREEZE DRYING; FREEZING; HEALTH HAZARD; HUMAN; INSTRUMENT STERILIZATION; KINETICS; LEACHING; LIFE CYCLE; LIQUID CHROMATOGRAPHY; MASS FRAGMENTOGRAPHY; MASS SPECTROMETRY; MOLECULAR WEIGHT; NEEDLE; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; ORGANIZATION; PATIENT SAFETY; PH; PURE RED CELL ANEMIA; QUALITATIVE ANALYSIS; QUALITY CONTROL; QUANTITATIVE STRUCTURE ACTIVITY RELATION; RISK ASSESSMENT; SHORT SURVEY; STANDARDIZATION; STORAGE TEMPERATURE; STRUCTURE ACTIVITY RELATION; SYRINGE; TEMPERATURE; TOXICOLOGY;

EID: 77951277134     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22012     Document Type: Short Survey

References (41)

1. Wang YJ, Chien YW. 1984. Sterile pharmaceutical packaging: Compatibility and Stability, Chapter IIIB, Leaching. Parenteral Drug Association. Bethesda, MD. pp 87-106.
2. Hung GW, Autian J. 1972. Use of thermal gravimetric analysis in sorption studies. II. Evaluation of diffusivity and solubility of a series of aliphatic alcohols in polyurethane. J Pharm Sci 61:1094-1098.
3. Hung GW, Nunez LJ, Autian J. 1975. Correlation of kinetic parameters and thermal behavior of segmented polyurethane elastomers with biological responses. J Pharm Sci 64:1492-1497.
4. Wu SL, Wang YJ, Hu J, Leung D. 1997. The detection of the organic extractables in a biotech product by liquid chromatography on-line with electrospray mass spectrometry. PDA J Pharm Sci Technol 51:229-237.
5. Bennett CL, Luminari S, Nissenson AR, Tallman MS, Klinge SA, McWilliams N, McKoy JM, Kim B, Lyons EA, Trifilio SM, Raisch DW, Evens AM, Kuzel TM, Schumock GT, Belknap SM, Locatelli F, Rossert J, Casadevall N. 2004. Pure red-cell aplasia and epoetin therapy. N Engl J Med 351:1403-1408.
6. Schellekens H. 2002. Immunogenicity of therapeutic proteins: Clinical implications and future prospects. Clin Ther 24:1720-1740, discussion 1719.
7. Boven K, Stryker S, Knight J, Thomas A, van Regenmortel M, Kemeny DM, Power D, Rossert J, Casadevall N. 2005. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 67:2346-2353.
8. Sharma B. 2007. Immunogenicity of therapeutic proteins. Part 2: Impact of container closures. Biotechnol Adv 25:318-324.
9. Locatelli F, Aljama P, Barany P, Canaud B, Carrera F, Eckardt KU, Macdougall IC, Macleod A, Horl WH, Wiecek A, Cameron S. 2004. Erythropoiesis-stimulating agents and antibody-mediated pure red-cell aplasia: Here are we now and where do we go from here? Nephrol Dial Transplant 19:288-293.
10. Hermeling S, Schellekens H, Crommelin DJ, Jiskoot W. 2003. Micelle-associated protein in epoetin formulations: A risk factor for immunogenicity? Pharm Res 20:1903-1907.
11. Mueller R, Karle A, Vogt A, Kropshofer H, Ross A, Maeder K, Mahler HC. 2009. Evaluation of the immuno-stimulatory potential of stopper extractables and leachables by using dendritic cells as readout. J Pharm Sci 98:3548-3561.
12. Swift R, Nashed-Sauel Y, Liu W, Narhi L, Davis J. 2007. Tungsten, prefilled syringes and protein aggregation. ACS Meeting (BIOT 15), Boston, MA.
13. Bee JS, Nelson SA, Freund E, Carpenter JF, Randolph TW. 2009. Precipitation of a monoclonal antibody by soluble tungsten. J Pharm Sci 98:3290-3301.
14. Jenke DR, Jene JM, Poss M, Story J, Tsilipetros T, Odufu A, Terbush W. 2005. Accumulation of extractables in buffer solutions from a polyolefin plastic container. Int J Pharm 297:120-133.
15. Thirumangalathu R, Krishnan S, Ricci MS, Brems DN, Randolph TW, Carpenter JF. 2009. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J Pharm Sci 98:3167-3181.
16. Jones LS, Kaufmann A, Middaugh CR. 2005. Silicone oil induced aggregation of proteins. J Pharm Sci 94:918-927.
17. Bernstein RK. 1987. Clouding and deactivation of clear (regular) human insulin: Association with silicone oil from disposable syringes? Diabetes Care 10:786-787.
18. Baldwin RN. 1988. Contamination of insulin by silicone oil: A potential hazard of plastic insulin syringes. Diabetes Med 5:789-790.
19. Chantelau E. 1989. Silicone oil contamination of insulin. Diabetes Med 6:278.
20. Rathore N, Rajan RS. 2008. Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol Prog 24:504-514.
21. Guidance for Industry. 1999. Container closure systems for packaging human drugs and biologics. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration.
22. Markovic I. 2007. Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: A risk-based perspective. Expert Opin Drug Saf 6:487-491.
23. Yu X, Wood D, Ding X. 2008. Extractables and leachables: Study approach for disposable materials used in bioprocessing. Biopharm Int 21:42-51.
24. Norwood DL, Paskiet D, Ruberto M, Feinberg T, Schroeder A, Poochikian G, Wang Q, Deng TJ, DeGrazio F, Munos MK, Nagao LM. 2008. Best practices for extractables and leachables in orally inhaled and nasal drug products: An overview of the PQRI recommendations. Pharm Res 25:727-739.
25. Treuheit MJ, Kosky AA, Brems DN. 2002. Inverse relationship of protein concentration and aggregation. Pharm Res 19:511-516.
26. Mizutani T. 1980. Decreased activity of proteins adsorbed onto glass surfaces with porous glass as a reference. J Pharm Sci 69:279-282.
27. Hill SS, Shaw BR, Wu AH. 2003. Plasticizers, antioxidants, and other contaminants found in air delivered by PVC tubing used in respiratory therapy. Biomed Chromatogr 17:250-262.
28. Jenke D. 2007. An extractables/leachables strategy facilitated by collaboration between drug product vendors and plastic material/system suppliers. PDA J Pharm Sci Technol 61:17-23.
29. 2008. (661) Containers and plastics. In the United States Pharmacopoeia, USP 31.
30. 2008. (88) Biological reactivity tests, In Vitro. In the United States Pharmacopoeia, USP 31.
31. 2008. (87) Biological reactivity tests, In Vitro. In the United States Pharmacopoeia, USP 31.
32. Zhang F, Chang A, Karaisz K, Feng R, Cai J. 2004. Structural identification of extractables from rubber closures used for prefilled semisolid drug applicator by chromatography, mass spectrometry, and organic synthesis. J Pharm Biomed Anal 34:841-849.
33. Jenke DR. 2001. Evaluation of model solvent systems for assessing the accumulation of container extractables in drug formulations. Int J Pharm 224:51-60.
34. Pan C, Harmon F, Toscano K, Liu F, Vivilecchia R. 2008. Strategy for identification of leachables in packaged pharmaceutical liquid formulations. J Pharm Biomed Anal 46:520-527.
35. Wang Q. 2005. Selection of analytical techniques for pharmaceutical leachable studies. Am Pharm Rev 40:42-44.
36. 2005. ICH Q1A (R2) Stability testing of new drug substances and products.
37. Jenke DR. 2005. Linking extractables and leachables in container/closure applications. PDA J Pharm Sci Technol 59:265-281.
38. Jenke D. 2007. Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables. J Pharm Sci 96:2566-2581.
39. Ji JA, Borisov O, Ingham E, Ling V, Wang YJ. 2009. Compatibility of a protein topical gel with wound dressings. J Pharm Sci 98:595-605.
40. Northup S. 2005. Assessing the biological safety of extractable and leachable chemicals in pharmaceutical and medical products. Am Pharm Rev 20:38-42.
41. Ball D, Blanchard J, Jacobson-Kram D, McClellan RO, McGovern T, Norwood DL, Vogel W, Wolff R, Nagao L. 2007. Development of safety qualification thresholds and their use in orally inhaled and nasal drug product evaluation. Toxicol Sci 97:226-236.