Extractables Analysis of Single-Use Flexible Plastic Biocontainers

References

1. 1.↵
   1. Gorter A.,
   2. van de Griend R. J.,
   3. van Eendenburg J. D.,
   4. Haasnoot W. H.,
   5. Fleuren G. J.

   Production of bi-specific monoclonal antibodies in a hollow-fibre bioreactor. J. Immunol. Methods 1993, 161 (2), 145–150.

   OpenUrlPubMed
2. 2.↵
   1. Hsiao T. Y.,
   2. Bacani F. T.,
   3. Carvalho E. B.,
   4. Curtis W. R.

   Development of a low capital investment reactor system: application for plant cell suspension culture. Biotechnol. Prog. 1999, 15 (1), 114–122.

   OpenUrlPubMed
3. 3.↵
   1. Bruce M. P.,
   2. Boyd V.,
   3. Duch C.,
   4. White J. R.

   Dialysis-based bioreactor systems for the production of monoclonal antibodies—alternatives to ascites production in mice. J. Immunol. Methods 2002, 264 (1–2), 59–68.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Rao G.,
   2. Moreira A.,
   3. Brorson K.

   Disposable bioprocessing: the future has arrived. Biotechnol. Bioeng. 2009, 102 (2), 348–356.

   OpenUrlCrossRefPubMedWeb of Science
5. 5.↵
   1. Singh V.

   Disposable bioreactor for cell culture using wave-induced agitation. Cytotechnology 1999, 30 (1–3), 149–158.

   OpenUrlCrossRefPubMedWeb of Science
6. 6.↵
   1. Weber W.,
   2. Weber E.,
   3. Geisse S.,
   4. Memmert K.

   Optimisation of protein expression and establishment of the Wave Bioreactor for Baculovirus/insect cell culture. Cytotechnology 2002, 38 (1-3), 77–85.

   OpenUrlPubMed
7. 7.↵
   1. Lim J.,
   2. Sinclair A.

   Process economy of disposable manufacturing: process models to minimize upfront investment. Am. Pharm. Rev. 2007, 10 (6), 114–121.

   OpenUrl
8. 8.↵
   1. Foulon A.,
   2. Trach F.,
   3. Pralong A.,
   4. Proctor M.,
   5. Lim J.

   Using disposables in an antibody production process: a cost-effectiveness study of technology transfer between two production sites. BioProcess Int. 2008, 6 (Suppl. 3), 12–18.

   OpenUrl
9. 9.↵
   1. Mauter M.

   Environmental life-cycle assessment of disposable bioreactors. BioProcess Int. 2009, 7 (Suppl. 4), 18–28.

   OpenUrl
10. 10.↵
    1. Paust T.

    Technology Integration through Disposable—from Components to Systems. ISPE Nordic Conference on Disposables in Biopharma, Stockholm, Sweden, 2006.
11. 11.↵
    1. Eibl R.,
    2. Kaiser S.,
    3. Lombriser R.,
    4. Eibl D.

    Disposable bioreactors: the current state-of-the-art and recommended applications in biotechnology. Appl. Microbiol. Biotechnol. 2010, 86 (1), 41–49.

    OpenUrlCrossRefPubMedWeb of Science
12. 12.↵
    1. Jenke D.

    Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables. J. Pharm. Sci. 2007, 96 (10), 2566–2581.

    OpenUrlPubMed
13. 13.↵
    1. Jenke D. R.,
    2. Zietlow D.,
    3. Garber M. J.,
    4. Sadain S.,
    5. Reiber D.,
    6. Terbush W.

    Accumulation of organic compounds leached from plastic materials used in biopharmaceutical process containers. PDA J. Pharm. Sci. Technol. 2007, 61 (4), 286–302.

    OpenUrlAbstract/FREE Full Text
14. 14.↵
    1. Northup S. J.

    Assessing the biological safety of extractable and leachabe chemicals in pharmaceuticals and medical products. Am. Pharm. Rev. 2005, 8 (4), 38–43.

    OpenUrl
15. 15.↵
    1. Jenke D.

    Suitability-for-use consideration for prefilled syringes. Pharm. Technol. 2008, April 1, www.PharmTech.com.
16. 16.↵
    1. Liu D.,
    2. Nashed-Samuel Y.,
    3. Bondarenko P. V.,
    4. Brems D. N.,
    5. Ren D.

    Interactions between therapeutic proteins and acrylic acid leachable, PDA J. Pharm. Sci. Technol. 2012, 66 (1), 12–19.

    OpenUrlAbstract/FREE Full Text
17. 17.↵
    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 Text
18. 18.↵
    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 Text
19. 19.↵
    1. Hammond M.,
    2. Marghitoiu A.-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.

    OpenUrl
20. 20.↵
    ASTM F1980. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. ASTM international.
21. 21.↵
    For this calculation we assume a conservative value for the accelerated aging factor of Q10 = 1.8.
22. 22.↵
    TBPP is sold to polymer resin manufacturers under many trade names, including Songnox® 1680, Alkanox® 240, and others, but by far the most common is Irgafos® 168 from BASF.
23. 23.↵
    1. Reingruber E.,
    2. Buchberger W.

    Analysis of polyolefin stabilizers and their degradation products. J. Separation Sci. 2010, 33 (22), 3463–3475.

    OpenUrl
24. 24.↵
    1. Chirinos-Padrón A. J.,
    2. Hernández P. H.,
    3. Allen N. S.,
    4. Vasilion C.,
    5. Marshall G. P.,
    6. de Poortere M.

    Synergism of antioxidants in high density polyethylene. Polym. Degrad. Stab. 1987, 19 (2), 177–189.

    OpenUrl
25. 25.↵
    For the CBA results shown in Figure 2, Chinese Hampster Ovary (CHO) cells from an Amgen proprietary cell line were grown in 24-deepwell plates, using media (1.5 L) held in 10 L capacity bags for 3 days at 37 °C. Further CBA details can be found in Hammond et al. (19).
26. 26.↵
    In fact, the close overlap between dose response curves generated by bDtBPP spiking versus bDtBPP leached from bags in CBA tests demonstrates other potential leachables are not affecting CBA growth results. That is, bDtBPP leaching alone explains the observed growth curves.
27. 27.↵
    1. Jurkiewicz E.,
    2. Barbaroux M.,
    3. Husemann U.,
    4. Greller G.,
    5. Fenge C.

    Verification of a new biocompatible single-use film formulation with optimized additive content for multiple bioprocess applications. Biotechnol. Prog. 2014, 30 (5), 1171–1176.

    OpenUrl