References:
Bailey-Kellogg, C., Gutiérrez, A. H., Moise, L., Terry, F., Martin, W.
D., & De Groot, A. S. CHOPPI: A web tool for the analysis of
immunogenicity risk from host cell proteins in CHO-based protein
production. Biotechnology and Bioengineering, 111 (11), 2170-2182.
Bee, J. S., Tie, L., Johnson, D., Dimitrova, M. N., Jusino, K. C., &
Afdahl, C. D. Trace levels of the CHO host cell protease cathepsin D
caused particle formation in a monoclonal antibody product.Biotechnology Progress, 31 (5), 1360-1369.
Cheung, P., Emanuel, A., Heward, J., Maddalena, J., Toth, D., Saward,
L., & Kodihalli, S. (2016). Reduced immunogenic response to residual
CHO cell protein in recombinant factor IX (IB1001) drug product in
normal healthy rabbits. Haemophilia, 22 (3), E220-E222.
Chiu, J., Valente, K. N., Levy, N. E., Min, L., Lenhoff, A. M., & Lee,
K. H. Knockout of a difficult-to-remove CHO host cell protein,
lipoprotein lipase, for improved polysorbate stability in monoclonal
antibody formulations. Biotechnology and Bioengineering, 114 (5),
1006-1015.
Clarke, C., Gallagher, C., Kelly, R. M., Henry, M., Meleady, P., Frye,
C. C., . . . Clynes, M. (2019). Transcriptomic analysis of IgG4
Fc-fusion protein degradation in a panel of clonally-derived CHO cell
lines using RNASeq. 116 (6), 1556-1562. doi:10.1002/bit.26958
Congdon, R. W., Muth, G. W., & Splittgerber, A. G. (1993). The Binding
Interaction of Coomassie Blue with Proteins. Anal Biochem,
213 (2), 407-413.
de Maria, P. D., & Hollmann, F. (2015). On the (Un)greenness of
Biocatalysis: Some Challenging Figures and Some Promising Options.Frontiers in Microbiology, 6 .
de Zafra, C. L., Quarmby, V., Francissen, K., Vanderlaan, M., &
Zhu-Shimoni, J. Host cell proteins in biotechnology-derived products: A
risk assessment framework. Biotechnology and Bioengineering,
112 (11), 2284-2291.
Dixit, N., Salamat-Miller, N., Salinas, P. A., Taylor, K. D., & Basu,
S. K. Residual Host Cell Protein Promotes Polysorbate 20 Degradation in
a Sulfatase Drug Product Leading to Free Fatty Acid Particles. J
Pharm Sci, 105 (5), 1657-1666.
The European Agency for the Evaluation of Medicinal Products Human
Medicines Evaluation Unit
(1997). CPMP/BWP/382/97 .
FDA. (1997). Points to Consider in the Manufacture & Testing of
Monoclonal Products for Human Use. In.
Fischer, S. K., Cheu, M., Peng, K., Lowe, J., Araujo, J., Murray, E., .
. . Song, A. Specific Immune Response to Phospholipase B-Like 2 Protein,
a Host Cell Impurity in Lebrikizumab Clinical Material. Aaps J,
19 (1), 254-263.
Galanie, S., Thodey, K., Trenchard, I. J., Interrante, M. F., & Smolke,
C. D. (2015). SYNTHETIC BIOLOGY Complete biosynthesis of opioids in
yeast. Science, 349 (6252), 1095-1100.
Goey, C. H., Bell, D., & Kontoravdi, C. (2018). Mild hypothermic
culture conditions affect residual host cell protein composition
post-Protein A chromatography. MAbs, 10 (3), 476-487.
Guideline, I. (1999). Specifications: Test Procedures and Acceptance
Criteria for Biotechnological/Biological Products Q6B.International Conference on Harmonisation of Technical Requirement
for Registration of Pharmaceuticals for Human Use .
Gunawan, F., Nishihara, J., Liu, P., Sandoval, W., Vanderlaan, M.,
Zhang, H. D., & Krawitz, D. (2018). Comparison of platform host cell
protein ELISA to process-specific host cell protein ELISA.Biotechnology and Bioengineering, 115 (2), 382-389.
Hall, T., Sandefur, S. L., Frye, C. C., Tuley, T. L., & Huang, L.
Polysorbates 20 and 80 Degradation by Group XV Lysosomal Phospholipase
A2 Isomer X1 in Monoclonal Antibody Formulations. J Pharm Sci,
105 (5), 1633-1642.
Hanania, N. A., Noonan, M., Corren, J., Korenblat, P., Zheng, Y. A.,
Fischer, S. K., . . . Yen, K. (2015). Lebrikizumab in moderate-to-severe
asthma: pooled data from two randomised placebo-controlled studies.Thorax, 70 (8), 748-756.
Hogwood, C. E., Bracewell, D. G., & Smales, C. M. Measurement and
control of host cell proteins (HCPs) in CHO cell bioprocesses.Curr Opin Biotechnol, 30 , 153-160.
Huffman, M. A., Fryszkowska, A., Alvizo, O., Borra-Garske, M., Campos,
K. R., Canada, K. A., . . . Yang, H. (2019). Design of an in vitro
biocatalytic cascade for the manufacture of islatravir. Science,
366 (6470), 1255-1259. doi:10.1126/science.aay8484
Jawa, V., Joubert, M. K., Zhang, Q., Deshpande, M., Hapuarachchi, S.,
Hall, M. P., & Flynn, G. C. Evaluating Immunogenicity Risk Due to Host
Cell Protein Impurities in Antibody-Based Biotherapeutics. Aaps J,
18 (6), 1439-1452.
Jiskoot, W., Rispens, T., & Kijanka, G. (2019). Immunogenicity of
Therapeutic Proteins. In (pp. 139-150).
John A. McIntosh1*, Z. L., Brian M. Andresen2*, Nastaran Salehi
Marzijarani1, Jeffrey C. Moore1, Nicholas M. Marshall1, Margie
Borra-Garske3, Jennifer V. Obligacion1, Patrick S. Fier1, Feng Peng1,
Jacob H. Forstater1, Matthew S. Winston1, Chihui An1, Wonsuk Chang2,
Jongwon Lim2, Mark A. Huffman1, Steven P. Miller1, Fuh-Rong Tsay1,
Michael D. Altman2, Charles A. Lesburg2, Dietrich Steinhuebel1, B.
Wesley Trotter2, Jared N. Cumming2, Alan Northrup2, Xiaodong Bu1,
Benjamin F. Mann1, Mirlinda Biba1, Kaori Hiraga1, Grant S. Murphy1,
Joshua N. Kolev1, Amanda Makarewicz1, Weilan Pan1, Iman Farasat1, Rachel
S. Bade1, Kevin Stone1, Duan Da3, Oscar Alviso3, Donovan Adpressa2, Erik
Guetschow1, Erik Hoyt1, Erik L. Regalado1, Steve Castro1, Nelo Rivera1,
Joseph P. Smith1, Fengqiang Wang1, Alejandro Crespo1, Deeptak Verma1,
Stephanus Axnanda1, Zachary Dance1, Paul N. Devine1, David Tschaen1,
Keith A. Canada1, Paul G. Bulger1, Benjamin D. Sherry1, Matthew D.
Truppo1 , Rebecca T. Ruck1, Louis-Charles Campeau1, David Jonathan
Bennett2, Guy R. Humphrey1, Kevin R. Campos1, Matthew L. Maddess1.
(2022). A kinase-cGAS cascade to synthesize a therapeutic STING
activator Nature
Jones, M., Palackal, N., Wang, F., Gaza-Bulseco, G., Hurkmans, K., Zhao,
Y., . . . Connolly, T. (2021). “High-risk” host cell proteins (HCPs):
A multi-company collaborative view. Biotechnology and
Bioengineering, 118 (8), 2870-2885.
doi:https://doi.org/10.1002/bit.27808
Lama, L., Adura, C., Xie, W., Tomita, D., Kamei, T., Kuryavyi, V., . . .
Tuschl, T. (2019). Development of human cGAS-specific small-molecule
inhibitors for repression of dsDNA-triggered interferon expression.Nature Communications, 10 (1), 2261.
doi:10.1038/s41467-019-08620-4
Luo, H. B., Tie, L., Cao, M. Y., Hunter, A. K., Pabst, T. M., Du, J. L.,
. . . Wang, W. K. (2019). Cathepsin L Causes Proteolytic Cleavage of
Chinese-Hamster-Ovary Cell Expressed Proteins During Processing and
Storage: Identification, Characterization, and Mitigation.Biotechnology Progress, 35 (1).
Novotna, B., Vanekova, L., Zavrel, M., Budesinsky, M., Dejmek, M.,
Smola, M., . . . Birkus, G. (2019). Enzymatic Preparation of
2’-5’,3’-5’-Cyclic Dinucleotides, Their Binding Properties to Stimulator
of Interferon Genes Adaptor Protein, and Structure/Activity
Correlations. J Med Chem, 62 (23), 10676-10690.
doi:10.1021/acs.jmedchem.9b01062
Patel, R. N. (2006). Biocatalysis: Synthesis of chiral intermediates for
drugs. Current Opinion in Drug Discovery & Development, 9 (6),
741-764.
Paulo, J. A. (2016). Sample preparation for proteomic analysis using a
GeLC-MS/MS strategy. Journal of biological methods, 3 (3), e45.
doi:10.14440/jbm.2016.106
Reetz, M. T. (2013). Biocatalysis in Organic Chemistry and
Biotechnology: Past, Present, and Future. Journal of the American
Chemical Society, 135 (34), 12480-12496.
Reijers, J. A. A., Malone, K. E., Bajramovic, J. J., Verbeek, R.,
Burggraaf, J., & Moerland, M. (2019). Adverse immunostimulation caused
by impurities: The dark side of biopharmaceuticals. British
Journal of Clinical Pharmacology, 85 (7), 1418-1426.
Romer, T., Peter, F., Saenger, P., Starzyk, J., Koehler, B., Korman, E.,
. . . Berghout, A. J. J. o. E. I. (2007). Efficacy and safety of a new
ready-to-use recombinant human growth hormone solution. 30 (7),
578-589. doi:10.1007/bf03346352
Saenger, P. (2009). Current status of biosimilar growth hormone.International journal of pediatric endocrinology, 2009 ,
370329-370329. doi:10.1155/2009/370329
Smith, J. P., Ralbovsky, N. M., Lauro, M. L., Hoyt, E., Guetschow, E.
D., Wang, F., . . . Bu, X. (2022). Quantitation and speciation of
residual protein within active pharmaceutical ingredients using image
analysis with SDS-PAGE. J Pharm Biomed Anal, 207 , 114393.
doi:10.1016/j.jpba.2021.114393
Tal, M., Silberstein, A., & Nusser, E. (1985). Why Does Coomassie
Brilliant Blue-R Interact Differently with Different Proteins - a
Partial Answer. Journal of Biological Chemistry, 260 (18),
9976-9980.
Vanderlaan, M., Zhu-Shimoni, J., Lin, S. S., Gunawan, F., Waerner, T.,
& Van Cott, K. E. (2018). Experience with Host Cell Protein Impurities
in Biopharmaceuticals. Biotechnology Progress, 34 (4), 828-837.
Wang, F. Q., Richardson, D., & Shameem, M. (2015). Host-Cell Protein
Measurement and Control. Biopharm International, 28 (6), 32-+.
Wang, X., Hunter, A. K., & Mozier, N. M. (2009). Host cell proteins in
biologics development: Identification, quantitation and risk assessment.Biotechnology and Bioengineering, 103 (3), 446-458.
Weiss W., W. F., Görg A. (2009). Protein Detection and Quantitation
Technologies for Gel-Based Proteome Analysis. In S. A. Reinders J.
(Ed.), Proteomics. Methods in Molecular Biology™ (Methods and
Protocols) . https://doi.org/10.1007/978-1-60761-157-8_4: Humana
Press
Wells, A. S., Finch, G. L., Michels, P. C., & Wong, J. W. (2012). Use
of Enzymes in the Manufacture of Active Pharmaceutical Ingredients-A
Science and Safety-Based Approach To Ensure Patient Safety and Drug
Quality. Organic Process Research & Development, 16 (12),
1986-1993.
Wells, A. S., Wong, J. W., Michels, P. C., Entwistle, D. A., Fandrick,
K., Finch, G. L., . . . Watson, T. J. (2016). Case Studies Illustrating
a Science and Risk-Based Approach to Ensuring Drug Quality When Using
Enzymes in the Manufacture of Active Pharmaceuticals Ingredients for
Oral Dosage Form. Organic Process Research & Development, 20 (3),
594-601.
Woodley, J. M. (2008). New opportunities for biocatalysis: making
pharmaceutical processes greener. Trends in Biotechnology, 26 (6),
321-327.
Zhou, W., Whiteley, A. T., Mann, C. C. D., Morehouse, B. R., Nowak, R.
P., Fischer, E. S., . . . Kranzusch, P. J. (2018). Structure of the
Human cGAS-DNA Complex Reveals Enhanced Control of Immune Surveillance.Cell, 174 (2), 300-+.
Zhu-Shimoni, J., Yu, C., Nishihara, J., Wong, R. M., Gunawan, F., Lin,
M., . . . Vanderlaan, M. (2014). Host Cell Protein Testing by ELISAs and
the Use of Orthogonal Methods. Biotechnology and Bioengineering,
111 (12), 2367-2379.