Hamster phospholipase B-like 2 (PLBL2): A host-cell protein impurity in therapeutic monoclonal antibodies derived from chinese hamster ovary cells

BioProcess International

Volumn 13, Issue , 2015, Pages

  Vanderlaan, Martin ^a   Sandoval, Wendy ^a   Liu, Peter ^a   Nishihara, Julie ^a   Tsui, George ^a   Lin, Margaret ^a   Gunawan, Feny ^a   Parker, Sara ^a   Wong, Robert Ming ^a   Low, Justin ^a   Wang, Xiangdan ^a   Yang, Jihong ^a   Veeravalli, Karthik ^a   McKay, Patrick ^a   Yu, Chris ^a   O'Connell, Lori ^a   Tran, Benjamin ^a   Vij, Rajesh ^a   Fong, Chris ^a   Francissen, Kathleen ^a   Zhu Shimoni, Judith ^a   Quarmby, Valerie ^a   Krawitz, Denise ^a   more..

^a GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN; LYSOPHOSPHOLIPASE; MONOCLONAL ANTIBODY; PHOSPHOLIPASE B LIKE 2; UNCLASSIFIED DRUG;

CHO CELL LINE; CULTURE MEDIUM; DRUG IMPURITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FERMENTATION; REVIEW;

CRICETINAE; CRICETULUS GRISEUS;

EID: 84928711702     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (25)

1. Tscheliessnig AL, et al. Host Cell Protein Analysis in Therapeutic Protein Bioprocessing: Methods and Applications. Biotechnol. J. 8(6) 2013: 655-670.
2. Wang X, Hunter AK, Mozier NM. Host Cell Proteins in Biologics Development: Identification, Quantitation, and Risk Assessment. Biotechnol. Bioeng. 103(3) 2009: 446-458.
3. Zhu-Shimoni J, et al. Host Cell Protein Testing By ELISAs and the Use of Orthogonal Methods. Biotechnol. Bioeng. 111(12) 2014: 2367-2379.
4. Anicetti VR, et al. Immunoassay for the Detection of E. coli Proteins in Recombinant DNA Derived Human Growth Hormone. J. Immunol. Meth. 91(2) 1986: 213-224.
5. Corren, J, et al. Lebrikizumab Treatment in Adults with Asthma. New England J. Med. 365(12) 2011: 1088-1098.
6. McCullogh KC, Spier RE. Monoclonal Antibodies in Biotechnology. Cambridge University Press: New York, NY, 2009.
7. Wild D. The Immunoassay Handbook: Theory and Applications of Ligand Binding, ELISA, and Related Techniques, Fourth Edition. Elsevier Science: Oxford, UK, 2013.
8. Gagnon P, et al. A Ceramic Hydroxyapatite-Based Purification Platform: Simultaneous Removal of Leached Protein A, Aggregates, DNA, and Endotoxins from MAbs. BioProcess Int. 4(2) 2006: 50-60.
9. Stanker LH, Vanderlaan M, Juarez-Salinas H. One-Step Purification of Mouse Monoclonal Antibodies from Ascites Fluid By Hydroxylapatite Chromatography. J. Immunol. Meth. 76(1) 1985: 157-169.
10. Champion KM, et al. Comparison of the Escherichia coli Proteomes for Recombinant Human Growth Hormone Producing and Nonproducing Fermentations. Proteomics 3(7) 2003: 1365-1373.
11. Wong AW, Baginski TK, Reilly DE. Enhancement of DNA Uptake in FUT8-Deleted CHO Cells for Transient Production of Afucosylated Antibodies. Biotechnol. Bioeng. 106(5) 2010: 751-763.
12. Deuschl F, et al. Molecular Characterization of the Hypothetical 66.3-kDa Protein in Mouse: Lysosomal Targeting, Glycosylation, Processing, and Tissue Distribution. FEBS Lett. 580(24) 2006: 5747-5752.
13. Lakomek K, et l. Initial Insight into the Function of the Lysosomal 66.3 Kda Protein from Mouse By Means of X-Ray Crystallography. BMC Struct. Biol. 9, 2009: 56.
14. Repo H, et al. Is the Bovine Lysosomal Phospholipase B-Like Protein an Amidase? Proteins 82(2) 2014: 300-311.
15. Sisodiya VN, et al. Studying Host Cell Protein Interactions with Monoclonal Antibodies Using High-Throughput Protein A Chromatography. Biotechnol. J. 7(10) 2012: 1233-1241.
16. Hunter AK, et al. Separation of Product Associating E. coli Host Cell Proteins OppA and DppA from Recombinant Apolipoprotein A-I(Milano) in an Industrial HIC Unit Operation. Biotechnol. Progr. 25(2) 2009: 446-453.
17. Levy NE, et al. Identification and Characterization of Host Cell Protein Product-Associated Impurities in Monoclonal Antibody Bioprocessing. Biotechnol. Bioeng. 111(5) 2014: 904-912.
18. Nogal B, Chhiba K, Emery JC. Select Host Cell Proteins Coelute with Monoclonal Antibodies in Protein A Chromatography. Biotechnol. Progr. 28(2) 2012: 454-458.
19. Wilson MR, Easterbrook-Smith SB. Clusterin Binds By a Multivalent Mechanism to the Fc and Fab Regions of IgG. Biochim. Biophys. Acta. 1159(3) 1992: 319-326.
20. Zhang Q, et al. Comprehensive Tracking of Host Cell Proteins During Monoclonal Antibody Purifications Using Mass Spectrometry. MAbs 6(3) 2014:659-670.
21. Chen SC, et al. Purification and Characterization of Secretory Phospholipase B, Lysophospholipase, and Lysophospholipase/Transacylase from a Virulent Strain of the Pathogenic Fungus Cryptococcus neoformans. Biochem. J. 347(2) 2000: 431-439.
22. Santangelo RT, et al. Detection of Antibodies to Phospholipase B in Patients Infected with Cryptococcus Neoformans By Enzyme-Linked Immunosorbent Assay (ELISA). Med. Mycol. 43(4) 2005: 335-341.
23. Bailey-Kellogg C, et al. CHOPPI: A Web Tool for the Analysis of Immunogenicity Risk from Host Cell Proteins in CHO-Based Protein Production. Biotechnol. Bioeng. 111(11) 2014: 2170-2182.
24. Rosenberg AS, Worobec A. Immunogenicity Concerns of Therapeutic Protein Products, Part 2: Considering Host- Specific and Product-Specific Factors Impacting Immunogenicity. BioPharm Int. December 2004.
25. Koren E, et al. Recommendations on Risk-Based Strategies for Detection and Characterization of Antibodies Against Biotechnology Products. J. Immunol. Meth. 333(1-2) 2008: 1-9.