-
1
-
-
9644279453
-
Comparison of the mouse antibody production (MAP) assay and polymerase chain reaction (PCR) assays for the detection of viral contaminants
-
Bauer, B.A., Besch-Williford, C.L., Riley, L.K. (2004) Comparison of the mouse antibody production (MAP) assay and polymerase chain reaction (PCR) assays for the detection of viral contaminants. Biologicals 32: 177-182.
-
(2004)
Biologicals
, vol.32
, pp. 177-182
-
-
Bauer, B.A.1
Besch-Williford, C.L.2
Riley, L.K.3
-
2
-
-
0037006883
-
Development of anti-CD4 MAb hu5A8 for treatment of HIV-1 infection: preclinical assessment in nonhuman primates
-
Boon, L., Holland, B., Gordon, W., Liu, P., Shiau, F., Shanahan, W., Reimann, K.A., Fung, M. (2002a) Development of anti-CD4 MAb hu5A8 for treatment of HIV-1 infection: preclinical assessment in nonhuman primates. Toxicology 172: 191-203.
-
(2002)
Toxicology
, vol.172
, pp. 191-203
-
-
Boon, L.1
Holland, B.2
Gordon, W.3
Liu, P.4
Shiau, F.5
Shanahan, W.6
Reimann, K.A.7
Fung, M.8
-
3
-
-
0037093613
-
Preclinical assessment of anti-CD40 Mab 5D12 in cynomolgus monkeys
-
Boon, L., Laman, J.D., Ortiz-Buijsse, A., den Hartog, M.T., Hoffenberg, S., Liu, P., Shiau, F., de Boer, M. (2002b) Preclinical assessment of anti-CD40 Mab 5D12 in cynomolgus monkeys. Toxicology 174: 53-65.
-
(2002)
Toxicology
, vol.174
, pp. 53-65
-
-
Boon, L.1
Laman, J.D.2
Ortiz-Buijsse, A.3
Den Hartog, M.T.4
Hoffenberg, S.5
Liu, P.6
Shiau, F.7
De Boer, M.8
-
4
-
-
0035121807
-
Use of a quantitative product-enhanced reverse transcriptase assay to monitor retrovirus levels in mAb cell-culture and downstream processing
-
Brorson, K., Swann, P.G., Lizzio, E., Maudru, T., Peden, K., Stein, K.E. (2001) Use of a quantitative product-enhanced reverse transcriptase assay to monitor retrovirus levels in mAb cell-culture and downstream processing. Biotechnol Prog 17: 188-196.
-
(2001)
Biotechnol Prog
, vol.17
, pp. 188-196
-
-
Brorson, K.1
Swann, P.G.2
Lizzio, E.3
Maudru, T.4
Peden, K.5
Stein, K.E.6
-
5
-
-
0036144935
-
Evaluation of a quantitative product-enhanced reverse transcriptase assay to monitor retrovirus in mAb cell-culture
-
Brorson, K., Xu, Y., Swann, P.G., Hamilton, E., Mustafa, M., de Wit, C., Norling, L.A., Stein, K.E. (2002) Evaluation of a quantitative product-enhanced reverse transcriptase assay to monitor retrovirus in mAb cell-culture. Biologicals 30: 15-26.
-
(2002)
Biologicals
, vol.30
, pp. 15-26
-
-
Brorson, K.1
Xu, Y.2
Swann, P.G.3
Hamilton, E.4
Mustafa, M.5
De Wit, C.6
Norling, L.A.7
Stein, K.E.8
-
6
-
-
0037420743
-
Bracketed generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteins
-
Brorson, K., Krejci, S., Lee, K., Hamilton, E., Stein, K., Xu, Y. (2003) Bracketed generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteins. Biotechnol Bioeng 82: 321-329.
-
(2003)
Biotechnol Bioeng
, vol.82
, pp. 321-329
-
-
Brorson, K.1
Krejci, S.2
Lee, K.3
Hamilton, E.4
Stein, K.5
Xu, Y.6
-
7
-
-
0033921144
-
Preclinical development of keliximab, a Primatized anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies
-
Bugelski, P.J., Herzyk, D.J., Rehm, S., Harmsen, A.G., Gore, E.V., Williams, D.M., Maleeff, B.E., Badger, A.M., Truneh, A., O'Brien, S.R., Macia, R.A., Wier, P.J., Morgan, D.G., Hart, T.K. (2000) Preclinical development of keliximab, a Primatized anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies. Hum Exp Toxicol 19: 230-243.
-
(2000)
Hum Exp Toxicol
, vol.19
, pp. 230-243
-
-
Bugelski, P.J.1
Herzyk, D.J.2
Rehm, S.3
Harmsen, A.G.4
Gore, E.V.5
Williams, D.M.6
Maleeff, B.E.7
Badger, A.M.8
Truneh, A.9
O'Brien, S.R.10
Macia, R.A.11
Wier, P.J.12
Morgan, D.G.13
Hart, T.K.14
-
8
-
-
0041303557
-
Animal models as indicators of immunogenicity of therapeutic proteins in humans
-
Bussiere, J.L. (2003) Animal models as indicators of immunogenicity of therapeutic proteins in humans. Dev Biol (Basel) 112: 135-139.
-
(2003)
Dev Biol (Basel)
, vol.112
, pp. 135-139
-
-
Bussiere, J.L.1
-
9
-
-
8344224534
-
Characterizing biological products and assessing comparability following manufacturing changes
-
Chirino, A.J., Mire-Sluis, A. (2004) Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 22: 1383-1391.
-
(2004)
Nat Biotechnol
, vol.22
, pp. 1383-1391
-
-
Chirino, A.J.1
Mire-Sluis, A.2
-
10
-
-
0033866627
-
Antibody humanization: a case of the 'Emperor's new clothes'?
-
Clark, M. (2000) Antibody humanization: a case of the 'Emperor's new clothes'? Immunol Today 21: 397-402.
-
(2000)
Immunol Today
, vol.21
, pp. 397-402
-
-
Clark, M.1
-
11
-
-
9644281455
-
Development of a PCR method for mycoplasma testing of Chinese hamster ovary cell cultures used in the manufacture of recombinant therapeutic proteins
-
Eldering, J.A., Felten, C., Veilleux, C.A., Potts, B.J. (2004) Development of a PCR method for mycoplasma testing of Chinese hamster ovary cell cultures used in the manufacture of recombinant therapeutic proteins. Biologicals 32: 183-193.
-
(2004)
Biologicals
, vol.32
, pp. 183-193
-
-
Eldering, J.A.1
Felten, C.2
Veilleux, C.A.3
Potts, B.J.4
-
12
-
-
0003590614
-
Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices
-
Food and Drug Administration, FDA
-
Food and Drug Administration (1987) Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices. FDA.
-
(1987)
-
-
-
13
-
-
0000230038
-
International Conference on Harmonisation: Guideline on detection of toxicity to reproduction for medicinal product. [Docket No. 93D-0140]
-
Food and Drug Administration
-
Food and Drug Administration (1994) International Conference on Harmonisation: Guideline on detection of toxicity to reproduction for medicinal product. [Docket No. 93D-0140]. Federal Register 59: 48746-48752.
-
(1994)
Federal Register
, vol.59
, pp. 48746-48752
-
-
-
14
-
-
84889354298
-
Points to consider in the manufacture and testing of therapeutic products for human use derived from transgenic animal. [Docket No. 95D-0131]
-
Food and Drug Administration
-
Food and Drug Administration (1995) Points to consider in the manufacture and testing of therapeutic products for human use derived from transgenic animal. [Docket No. 95D-0131]. Federal Register 60: 44036.
-
(1995)
Federal Register
, vol.60
, pp. 44036
-
-
-
15
-
-
84889439091
-
Guidance for industry; content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived product. [Docket No. 95D-0386]
-
Food and Drug Administration
-
Food and Drug Administration (1996a) Guidance for industry; content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived product. [Docket No. 95D-0386]. Federal Register 61: 1939-1940.
-
(1996)
Federal Register
, vol.61
, pp. 1939-1940
-
-
-
16
-
-
0007097059
-
International Conference on Harmonisation: Final guideline on stability testing of biotechnological/biological products [Docket No. 93D-0139]
-
Food and Drug Administration
-
Food and Drug Administration (1996b) International Conference on Harmonisation: Final guideline on stability testing of biotechnological/biological products [Docket No. 93D-0139]. Federal Register 61: 36466-36469.
-
(1996)
Federal Register
, vol.61
, pp. 36466-36469
-
-
-
17
-
-
0345452832
-
Points to consider in the manufacture and testing of monoclonal antibody products for human us. [Docket No. 94D-0259]
-
Food and Drug Administration
-
Food and Drug Administration (1997a) Points to consider in the manufacture and testing of monoclonal antibody products for human us. [Docket No. 94D-0259]. Federal Register 62: 9196-9197.
-
(1997)
Federal Register
, vol.62
, pp. 9196-9197
-
-
-
18
-
-
0011223898
-
International Conference on Harmonisation: S6 Guidance on preclinical safety evaluation of biotechnology-derived product. [Docket No. 97D-0113].
-
Food and Drug Administration
-
Food and Drug Administration (1997b) International Conference on Harmonisation: S6 Guidance on preclinical safety evaluation of biotechnology-derived product. [Docket No. 97D-0113]. Federal Register 62: 6515-61519.
-
(1997)
Federal Register
, vol.62
, pp. 6515-61519
-
-
-
19
-
-
0343537665
-
International Conference on Harmonisation: Guidance on nonclinical safety studies for the conduct of human clinical trials for pharmaceutical. [Docket No. 97D-0147]
-
Food and Drug Administration
-
Food and Drug Administration (1997c) International Conference on Harmonisation: Guidance on nonclinical safety studies for the conduct of human clinical trials for pharmaceutical. [Docket No. 97D-0147]. Federal Register 62: 62922.
-
(1997)
Federal Register
, vol.62
, pp. 62922
-
-
-
20
-
-
0032555890
-
International Conference on Harmonisation: Guidance on quality of biotechnological/biological products Q5D: Derivation and characterization of cell substrates used for the production of biotechnological/biological product. [Docket No. 97D-0159]
-
Food and Drug Administration
-
Food and Drug Administration (1998a) International Conference on Harmonisation: Guidance on quality of biotechnological/biological products Q5D: Derivation and characterization of cell substrates used for the production of biotechnological/biological product. [Docket No. 97D-0159]. Federal Register 63: 50244-50249.
-
(1998)
Federal Register
, vol.63
, pp. 50244-50249
-
-
-
21
-
-
0032564029
-
International Conference on Harmonisation: Guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origi. [Docket No. 96D-0058]
-
Food and Drug Administration
-
Food and Drug Administration (1998b) International Conference on Harmonisation: Guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origi. [Docket No. 96D-0058]. Federal Register 63: 51074-51084.
-
(1998)
Federal Register
, vol.63
, pp. 51074-51084
-
-
-
22
-
-
0035854839
-
International Conference on Harmonisation: Guidance on S7A safety pharmacology studies for human pharmaceuticals. [Docket No. D-1407]
-
Food and Drug Administration
-
Food and Drug Administration (2001) International Conference on Harmonisation: Guidance on S7A safety pharmacology studies for human pharmaceuticals. [Docket No. D-1407]. Federal Register 66: 36791-36792.
-
(2001)
Federal Register
, vol.66
, pp. 36791-36792
-
-
-
23
-
-
0013054225
-
Draft Guidance for Industry: Drugs, biologics, and medical devices derived from bioengineered plants for use in humans and animal. [Docket No. 02D324]
-
Food and Drug Administration
-
Food and Drug Administration (2002a) Draft Guidance for Industry: Drugs, biologics, and medical devices derived from bioengineered plants for use in humans and animal. [Docket No. 02D324]. Federal Register 67: 57828-57829.
-
(2002)
Federal Register
, vol.67
, pp. 57828-57829
-
-
-
24
-
-
84889265629
-
Guidance for Industry: Revised preventative measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood product. [Docket No. 97D-0318]
-
Food and Drug Administration
-
Food and Drug Administration (2002b) Guidance for Industry: Revised preventative measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood product. [Docket No. 97D-0318]. Federal Register 67: 2226-2227.
-
(2002)
Federal Register
, vol.67
, pp. 2226-2227
-
-
-
25
-
-
0008462934
-
International Conference on Harmonisation: Draft revised guidance on Q1A(R) stability testing of new drug substances and product. [Docket No. 93D-0139]
-
Food and Drug Administration
-
Food and Drug Administration (2002c) International Conference on Harmonisation: Draft revised guidance on Q1A(R) stability testing of new drug substances and product. [Docket No. 93D-0139]. Federal Register 65: 21446-21453.
-
(2002)
Federal Register
, vol.65
, pp. 21446-21453
-
-
-
26
-
-
84889401220
-
Guidance concerning demonstration of comparability of human biological product. [Docket No. 96D-0132]
-
Food and Drug Administration
-
Food and Drug Administration (2002d) Guidance concerning demonstration of comparability of human biological product. [Docket No. 96D-0132]. Federal Register 70: 37861-37862.
-
(2002)
Federal Register
, vol.70
, pp. 37861-37862
-
-
-
27
-
-
84889338393
-
International Conference on Harmonisation: Guidance on Q5 comparability of biotechnological/biological products subject to changes in their manufacturing proces. [Docket No. 2004D-0118]
-
Food and Drug Administration
-
Food and Drug Administration (2005) International Conference on Harmonisation: Guidance on Q5 comparability of biotechnological/biological products subject to changes in their manufacturing proces. [Docket No. 2004D-0118]. Federal Register 59: 48746-48752.
-
(2005)
Federal Register
, vol.59
, pp. 48746-48752
-
-
-
28
-
-
0036201914
-
Transcytosis and catabolism of antibody
-
Ghetie, V., Ward, E.S. (2002) Transcytosis and catabolism of antibody. Immunol Res 25: 97-113.
-
(2002)
Immunol Res
, vol.25
, pp. 97-113
-
-
Ghetie, V.1
Ward, E.S.2
-
29
-
-
0033855859
-
Clinical trials of antibody therapy
-
Glennie, M.J., Johnson, P.W. (2000) Clinical trials of antibody therapy. Immunol Today 21: 403-410.
-
(2000)
Immunol Today
, vol.21
, pp. 403-410
-
-
Glennie, M.J.1
Johnson, P.W.2
-
30
-
-
84889337243
-
Comparability studies for human therapeutics, preclinical and pharmacokinetic aspects
-
Green, M. (2002) Comparability studies for human therapeutics, preclinical and pharmacokinetic aspects. In Comparability Studies for Human Plasma-Derived Therapeutics-Workshop. http://www.fda.gov/cbr/minutes/plasma053002.htm.
-
(2002)
Comparability Studies for Human Plasma-Derived Therapeutics-Workshop
-
-
Green, M.1
-
31
-
-
84889482716
-
WHO Expert Committee on Biological Standardizatio. Highlights of the Meeting of October 1996
-
Griffiths, E. (1987) WHO Expert Committee on Biological Standardizatio. Highlights of the Meeting of October 1996. Biologicals 25: 339-362.
-
(1987)
Biologicals
, vol.25
, pp. 339-362
-
-
Griffiths, E.1
-
32
-
-
0035852787
-
A human myeloma cell line suitable for the generation of human monoclonal antibodies
-
Karpas, A., Dremucheva, A., Czepulkowski, B.H. (2001) A human myeloma cell line suitable for the generation of human monoclonal antibodies. Proc Natl Acad Sci USA 98: 1799-1804.
-
(2001)
Proc Natl Acad Sci USA
, vol.98
, pp. 1799-1804
-
-
Karpas, A.1
Dremucheva, A.2
Czepulkowski, B.H.3
-
33
-
-
0032979346
-
Pharmacology and safety assessment of humanized monoclonal antibodies for therapeutic use
-
Klingbeil, C., Hsu, D.H. (1999) Pharmacology and safety assessment of humanized monoclonal antibodies for therapeutic use. Toxicol Pathol 27: 1-3.
-
(1999)
Toxicol Pathol
, vol.27
, pp. 1-3
-
-
Klingbeil, C.1
Hsu, D.H.2
-
34
-
-
0016756272
-
Continuous cultures of fused cells secreting antibody of predefined specificity
-
Kohler, G., Milstein, C. (1975) Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 256: 495-497.
-
(1975)
Nature
, vol.256
, pp. 495-497
-
-
Kohler, G.1
Milstein, C.2
-
35
-
-
3142534409
-
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
-
Mire-Sluis, A.R., Barrett, Y.C., Devanarayan, V., Koren, E., Liu, H., Maia, M., Parish, T., Scott, G., Shankar, G., Shores, E., Swanson, S.J., Taniguchi, G., Wierda, D., Zuckerman, L.A. (2004) Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 289: 1-16.
-
(2004)
J Immunol Methods
, vol.289
, pp. 1-16
-
-
Mire-Sluis, A.R.1
Barrett, Y.C.2
Devanarayan, V.3
Koren, E.4
Liu, H.5
Maia, M.6
Parish, T.7
Scott, G.8
Shankar, G.9
Shores, E.10
Swanson, S.J.11
Taniguchi, G.12
Wierda, D.13
Zuckerman, L.A.14
-
36
-
-
27144457667
-
Monoclonal antibody successes in the clinic
-
Reichert, J.M., Rosensweig, C.J., Faden, L.B., Dewitz, M.C. (2005) Monoclonal antibody successes in the clinic. Nat Biotechnol 23: 1073-1078.
-
(2005)
Nat Biotechnol
, vol.23
, pp. 1073-1078
-
-
Reichert, J.M.1
Rosensweig, C.J.2
Faden, L.B.3
Dewitz, M.C.4
-
37
-
-
0033024643
-
Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond
-
Serabian, M.A., Pilaro, A.M. (1999) Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond. Toxicol Pathol 27: 27-31.
-
(1999)
Toxicol Pathol
, vol.27
, pp. 27-31
-
-
Serabian, M.A.1
Pilaro, A.M.2
-
38
-
-
0031104823
-
Overcoming obstacles to monoclonal antibody product development and approval
-
Stein, K.E. (1997) Overcoming obstacles to monoclonal antibody product development and approval. Trends Biotechnol 15: 88-90.
-
(1997)
Trends Biotechnol
, vol.15
, pp. 88-90
-
-
Stein, K.E.1
-
39
-
-
79959524146
-
A haplotype map of the human genome
-
International HapMap Consortium
-
International HapMap Consortium (2005) A haplotype map of the human genome. Nature 437: 1299-1320.
-
(2005)
Nature
, vol.437
, pp. 1299-1320
-
-
-
40
-
-
0000429944
-
Pharmacokinetics and metabolism of therapeutic and diagnostic antibodies
-
In: Ferraiolo, B., Mohler, M.A., Gloff, C.A. (eds) New York: Plenum Press, pp.
-
Trang, J.M. (1992) Pharmacokinetics and metabolism of therapeutic and diagnostic antibodies. In: Ferraiolo, B., Mohler, M.A., Gloff, C.A. (eds) Protein Pharmacokinetics and Metabolism. New York: Plenum Press, pp. 223-270.
-
(1992)
Protein Pharmacokinetics and Metabolism
, pp. 223-270
-
-
Trang, J.M.1
-
41
-
-
0033916950
-
Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFalpha monoclonal antibody
-
Treacy, G. (2000) Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFalpha monoclonal antibody. Hum Exp Toxicol 19: 226-228.
-
(2000)
Hum Exp Toxicol
, vol.19
, pp. 226-228
-
-
Treacy, G.1
-
42
-
-
0008929443
-
Short-term, subchronic and chronic toxicology studies
-
In: Hayes, W. (ed.) Philadelphia, PA: Taylor and Francis
-
Wilson, N., Hardisty, J.H. (2001) Short-term, subchronic and chronic toxicology studies. In: Hayes, W. (ed.) Principles and Methods of Toxicology. Philadelphia, PA: Taylor and Francis, pp. 917-957.
-
(2001)
Principles and Methods of Toxicology
, pp. 917-957
-
-
Wilson, N.1
Hardisty, J.H.2
|