A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization

Reference

1. 1.↵
   1. Diekmann S.,
   2. Durr C.,
   3. Herrmann A.,
   4. Lindner I.,
   5. Jozic D.

   Single Use Bioreactors for the Clinical Production of Monoclonal Antibodies—A Study To Analyze the Performance of a CHO Cell Line and the Quality of the Produced Monoclonal Antibody. BMC Proceedings 2011, 5 (Suppl 8), 103.

   OpenUrlGoogle Scholar
2. 2.↵
   1. Shukla A. A.,
   2. Gottschalk U.

   Single-use Disposable Technologies for Biopharmaceutical Manufacturing. Trends Biotechnol. 2013, 31 (3), 147–154.

   OpenUrlCrossRefPubMedGoogle Scholar
3. 3.↵
   1. Jenke D. R.

   Extractable/Leachable Substances from Plastic Materials Used as Pharmaceutical Product Containers/Devices. PDA J. Pharm. Sci. Technol. 2002, 56 (6), 332–371.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
4. 4.↵
   1. Jenke D. R.

   Extractable Substances from Plastic Materials Used in Solution Contact Applications: An Updated Review. PDA J. Pharm. Sci. Technol. 2006, 60 (3), 191–207.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
5. 5.↵
   1. Jenke D. R.

   Linking Extractables and Leachables in Container/Closure Applications. PDA J. Pharm. Sci. Technol. 2005, 59 (4), 265–281.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
6. 6.↵
   1. Silindir M.,
   2. Ozer Y.

   The Effect of Radiation on a Variety of Pharmaceuticals and Materials Containing Polymers. PDA J. Pharm. Sci. Technol. 2012, 66 (2), 184–199.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
7. 7.↵
   1. Hasanain F.,
   2. Guenther K.,
   3. Mullett W. M.,
   4. Craven E.

   Gamma Sterilization of Pharmaceuticals—A Review of the Irradiation of Excipients, Active Pharmaceutical Ingredients, and Final Drug Product Formulations. PDA J. Pharm. Sci. Technol. 2014, 68 (2), 113–137.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
8. 8.↵
   1. Markovic I.

   Evaluation of Safety and Quality Impact of Extractable and Leachable Substances in Therapeutic Biologic Protein Products: A Risk-based Perspective. Expert Opinion on Drug Safety 2007, 6 (5), 487–491.

   OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
9. 9.↵
   1. Wakankar A. A.,
   2. Wang Y. J.,
   3. Canova-Davis E.,
   4. Ma S.,
   5. Schmalzing D.,
   6. Grieco J.,
   7. Milby T.,
   8. Reynolds T.,
   9. Mazzarella K.,
   10. Hoff E.,
   11. Gomez S.,
   12. Martin-Moe S.

   On Developing a Process for Conducting Extractable-leachable Assessment of Components Used for Storage of Biopharmaceuticals. J. Pharm. Sci. 2010, 99 (5), 2209–2218.

   OpenUrlPubMedGoogle Scholar
10. 10.↵
    1. Xiaochun Y.,
    2. Wood D.,
    3. Xiaoya D.

    Extractables and Leachables Study Approach for Disposable Materials Used in Bioprocessing. BioPharm International 2008, 21 (2), 42–51.

    OpenUrlGoogle Scholar
11. 11.↵
    1. Hammond M.,
    2. Marghitoiu L.,
    3. Lee H.,
    4. Perez L.,
    5. Rogers G.,
    6. Nashed-Samuel Y.,
    7. Nunn H.,
    8. Kline S.

    A Cytotoxic Leachable Compound from Single-use Bioprocess Equipment That Causes Poor Cell Growth Performance. Biotechnol. Prog. 2014, 30 (2), 332–337.

    OpenUrlGoogle Scholar
12. 12.↵
    1. Hammond M.,
    2. Nunn H.,
    3. Rogers G.,
    4. Lee H.,
    5. Marghitoiu A. L.,
    6. Perez L.,
    7. Nashed-Samuel Y.,
    8. Anderson C.,
    9. Vandiver M.,
    10. Kline S.

    Identification of a Leachable Compound Detrimental to Cell Growth in Single-use Bioprocess Containers. PDA J. Pharm. Sci. Technol. 2013, 67 (2), 123–134.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
13. 13.↵
    1. Wood J.,
    2. Mahajan E.,
    3. Shiratori M.

    Strategy for Selecting Disposable Bags for Cell Culture Media Applications Based on a Root-cause Investigation. Biotechnol. Prog. 2013, 29 (6), 1535–1549.

    OpenUrlGoogle Scholar
14. 14.↵
    1. Ratanji K. D.,
    2. Derrick J. P.,
    3. Dearman R. J.,
    4. Kimber I.

    Immunogenicity of Therapeutic Proteins: Influence of Aggregation. J. Immunotoxicol. 2014, 11 (2), 99–109.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
15. 15.↵
    1. Rosenberg A. S.

    Effects of Protein Aggregates: An Immunologic Perspective. AAPS J. 2006, 8 (3), E501–E507.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
16. 16.↵
    1. Sharma B.

    Immunogenicity of Therapeutic Proteins. Part 2: Impact of Container Closures. Biotechnology Advances 2007, 25 (3), 318–324.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
17. 17.↵
    1. Wang W.,
    2. Singh S. K.,
    3. Li N.,
    4. Toler M. R.,
    5. King K. R.,
    6. Nema S.

    Immunogenicity of Protein Aggregates—Concerns and Realities. Int. J. Pharm. 2012, 431 (1-2), 1–11.

    OpenUrlPubMedGoogle Scholar
18. 18.↵
    1. Salas-Solano O.,
    2. Tomlinson B.,
    3. Du S.,
    4. Parker M.,
    5. Strahan A.,
    6. Ma S.

    Optimization and Validation of a Quantitative Capillary Electrophoresis Sodium Dodecyl Sulfate Method for Quality Control and Stability Monitoring of Monoclonal Antibodies. Anal. Chem. 2006, 78 (18), 6583–6594.

    OpenUrlPubMedGoogle Scholar
19. 19.↵
    1. Shieh I. C.,
    2. Patel A. R.

    Predicting the Agitation-induced Aggregation of Monoclonal Antibodies Using Surface Tensiometry. Molecular Pharmaceutics 2015, 12 (9), 3184–3193.

    OpenUrlGoogle Scholar
20. 20.↵
    1. Shieh I. C.,
    2. Zasadzinski J. A.

    Visualizing Monolayers with a Water-soluble Fluorophore To Quantify Adsorption, Desorption, and the Double Layer. Proc. Natl. Acad. Sci. USA 2015, 112 (8), E826–E835.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
21. 21.↵
    1. Hewitt D.,
    2. Alvarez M.,
    3. Robinson K.,
    4. Ji J.,
    5. Wang Y. J.,
    6. Kao Y. H.,
    7. Zhang T.

    Mixed-mode and Reversed-phase Liquid Chromatography–Tandem Mass Spectrometry Methodologies To Study Composition and Base Hydrolysis of Polysorbate 20 and 80. J. Chromatogr, A 2011, 1218 (15), 2138–2145.

    OpenUrlPubMedGoogle Scholar
22. 22.↵
    1. Bee J. S.,
    2. Randolph T. W.,
    3. Carpenter J. F.,
    4. Bishop S. M.,
    5. Dimitrova M. N.

    Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals. J. Pharm. Sci. 2011, 100 (10), 4158–4170.

    OpenUrlGoogle Scholar
23. 23.↵
    1. Lelli M.,
    2. Rossini A. J.,
    3. Casano G.,
    4. Ouari O.,
    5. Tordo P.,
    6. Lesage A.,
    7. Emsley L.

    Hydrophobic Radicals Embedded in Neutral Surfactants for Dynamic Nuclear Polarization of Aqueous Environments at 9.4 Tesla. Chemical Communications (Cambridge, England) 2014, 50 (71), 10198–10201.

    OpenUrlGoogle Scholar
24. 24.↵
    1. Narang A. S.,
    2. Delmarre D.,
    3. Gao D.

    Stable Drug Encapsulation in Micelles and Microemulsions. Int. J. Pharm. 2007, 345 (1-2), 9–25.

    OpenUrlCrossRefPubMedGoogle Scholar
25. 25.↵
    1. Kerwin B. A.

    Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways. J. Pharm. Sci. 2008, 97 (8), 2924–2935.

    OpenUrlCrossRefPubMedGoogle Scholar