-
1
-
-
77951650496
-
-
International Conference on Harmonization. Q8(R2), Pharmaceutical development. Geneva, Switzerland Aug
-
International Conference on Harmonization. Q8(R2), Pharmaceutical development. Geneva, Switzerland. 2009 Aug.
-
(2009)
-
-
-
2
-
-
77951631411
-
-
US Food and Drug Administration. Guidance for industry: Q9 Quality risk management. Bethesda MD
-
US Food and Drug Administration. Guidance for industry: Q9 Quality risk management. Bethesda, MD; 2006.
-
(2006)
-
-
-
3
-
-
77951641506
-
-
US FDA. Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda MD
-
US FDA. Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda, MD; 2006.
-
(2006)
-
-
-
4
-
-
77951643689
-
-
US FDA. Guidance for industry Sept PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance
-
US FDA. Guidance for industry: PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. 2004 Sept.
-
(2004)
-
-
-
5
-
-
27144532832
-
Human antibodies from transgenic animals
-
Lonesberg IN. Human antibodies from transgenic animals. Nature Biotech. 2005;23:l:117-125.
-
(2005)
Nature Biotech.
, vol.23
, Issue.1
, pp. 117-125
-
-
Lonesberg, N.1
-
7
-
-
33846215917
-
Antibody constructs in cancer therapy; Protein engineering strategies to improve exposure in solid tumors
-
Beckman RA, Weiner LM, Davis HM. Antibody constructs in cancer therapy; protein engineering strategies to improve exposure in solid tumors. Cancer. 2007;109(2):170-179
-
(2007)
Cancer
, vol.109
, Issue.2
, pp. 170-179
-
-
Beckman, R.A.1
Weiner, L.M.2
Davis, H.M.3
-
8
-
-
34748865088
-
Antibodies therapeutics:Isotype and glycoform selection
-
Ravetch J. Antibodies therapeutics:isotype and glycoform selection. Expert opin biol ther. 2007; 7(9):1401-1413
-
(2007)
Expert Opin Biol Ther.
, vol.7
, Issue.9
, pp. 1401-1413
-
-
Ravetch, J.1
-
9
-
-
39749201659
-
Isomerization of a single aspartyl residue of anti-epidermal growth factor receptor immunoglobulin 2 antibody highlights the role avidity plays in antibody activity
-
DOI 10.1021/bi7018223
-
Rehder DS, Chelius D, McAuley A, Dillon TM, Xiao G, Crouse-Zeineddini J, et al. Isomerization of a single asparty residue of anti-epidermal growth factor receptor immunoglobulin gamm2 antibody highlights the role avidity plays in antibody activity. Biochemistry. 2008;47(8):2,518-530 (Pubitemid 351304557)
-
(2008)
Biochemistry
, vol.47
, Issue.8
, pp. 2518-2530
-
-
Rehder, D.S.1
Chelius, D.2
McAuley, A.3
Dillon, T.M.4
Xiao, G.5
Crouse-Zeineddini, J.6
Vardanyan, L.7
Perico, N.8
Mukku, V.9
Brems, D.N.10
Matsumura, M.11
Bondarenko, P.V.12
-
10
-
-
38449112154
-
Engineering antibodies for stability and efficient folding
-
Honegger A. Engineering antibodies for stability and efficient folding. Handb Exp Pharmacol. 2008;181:47-68.
-
(2008)
Handb Exp Pharmacol.
, vol.181
, pp. 47-68
-
-
Honegger, A.1
-
11
-
-
60149106150
-
Quality by Design for Pharmaceuticals: Regulatory perspective and approach
-
Rathore AR, Winkle H. Quality by Design for Pharmaceuticals: Regulatory perspective and approach. Nature Biotechnol. 2009. 27(1):26-34.
-
(2009)
Nature Biotechnol.
, vol.27
, Issue.1
, pp. 26-34
-
-
Rathore, A.R.1
Winkle, H.2
-
12
-
-
34447642317
-
Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein IIb/IIIa antagonist
-
DOI 10.1016/j.jpba.2007.03.030, PII S0731708507002002
-
Barrett YC, Ebling W, Pieniaszek H, Billheimer J, Seiffert D. Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein llb/llla antagonist. J Pharm Biomed Anal. 2007 Aug 15;44(4):938-946 (Pubitemid 47095191)
-
(2007)
Journal of Pharmaceutical and Biomedical Analysis
, vol.44
, Issue.4
, pp. 938-946
-
-
Barrett, Y.C.1
Ebling, W.2
Pieniaszek, H.3
Billheimer, J.4
Seiffert, D.5
-
13
-
-
35848955440
-
Application of analytical detection concepts to immunogenicity testing
-
DOI 10.1021/ac071364d
-
Klakamp SL, Lu H, Tabrizi M, Funelas C, Roskos LK, Coleman D. Application of analytical detection concepts to immunogenicity testing. Anal Chem. 2007 Nov l;79(21):8,176-184 (Pubitemid 350060015)
-
(2007)
Analytical Chemistry
, vol.79
, Issue.21
, pp. 8176-8184
-
-
Klakamp, S.L.1
Lu, H.2
Tabrizi, M.3
Funelas, C.4
Roskos, L.K.5
Coleman, D.6
-
14
-
-
3142534409
-
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
-
DOI 10.1016/j.jim.2004.06.002, PII S0022175904001978
-
Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004 Jun;289(1-2):1-16. (Pubitemid 38900899)
-
(2004)
Journal of Immunological Methods
, vol.289
, Issue.1-2
, 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
-
15
-
-
84889348857
-
Using a risk assessment process to determine criticality of product quality attributes
-
In: Rathore AS, Mhatre R, editors Hoboken: Wiley
-
Schenerman MA, Axley MJ, Oliver CN, Ram K, Wasserman GF. Using a risk assessment process to determine criticality of product quality attributes. In: Rathore AS, Mhatre R, editors. Quality by design for biopharmaceuticals: principles and case studies. Hoboken: Wiley; 2009.
-
(2009)
Quality by Design for Biopharmaceuticals: Principles and Case Studies
-
-
Schenerman, M.A.1
Axley, M.J.2
Oliver, C.N.3
Ram, K.4
Wasserman, G.F.5
-
16
-
-
33947397632
-
Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
-
DOI 10.1016/j.jim.2006.12.004, PII S0022175906003693
-
Gupta S, Indelicato SR, Jethwa V, Kawabata T, Kelley M, Mire-Sluis AR, et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods. 2007 Apr 10;321(1-2):1-18. (Pubitemid 46454303)
-
(2007)
Journal of Immunological Methods
, vol.321
, Issue.1-2
, pp. 1-18
-
-
Gupta, S.1
Indelicato, S.R.2
Jethwa, V.3
Kawabata, T.4
Kelley, M.5
Mire-Sluis, A.R.6
Richards, S.M.7
Rup, B.8
Shores, E.9
Swanson, S.J.10
Wakshull, E.11
-
18
-
-
45149110911
-
Defining process design space for biotech products: Case study of Pichia pastoris fermentation
-
DOI 10.1021/bp070338y
-
Harms J, Wang X, Kim T, Yang J, Rathore AS. Defining design space for biotech products: Case study of Pichia pastoris fermentation. Biotechnol Prog. 2008:24(3):655-662 (Pubitemid 351832721)
-
(2008)
Biotechnology Progress
, vol.24
, Issue.3
, pp. 655-662
-
-
Harms, J.1
Wang, X.2
Kim, T.3
Yang, X.4
Rathore, A.S.5
-
19
-
-
33847611524
-
Scale-down models for purification processes: Approaches and applications
-
In Rathore AS, Sofer G, editors. New York: Taylor and Francis
-
Godavarti R, Petrone J, Robinson J, Wright R, Kelley BD. Scale-down models for purification processes: approaches and applications. In Rathore AS, Sofer G, editors. Process validation in manufacturing of biopharmaceuticals. New York: Taylor and Francis; 2005.
-
(2005)
Process Validation in Manufacturing of Biopharmaceuticals
-
-
Godavarti, R.1
Petrone, J.2
Robinson, J.3
Wright, R.4
Kelley, B.D.5
-
21
-
-
77951623849
-
-
Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products Federal Register. July 2
-
Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program. Federal Register. July 2 2008;73(128):37972-37974
-
(2008)
Notice of Pilot Program.
, vol.73
, Issue.128
, pp. 37972-37974
-
-
-
22
-
-
77951630111
-
-
Parenteral Drug Association. PDA Technical Report 42. Bethesda MD: PDA; Sept
-
Parenteral Drug Association. PDA Technical Report 42. Process Validation of Protein Manufacturing. Bethesda, MD: PDA; Sept 2005;59(S-4):1-28.
-
(2005)
Process Validation of Protein Manufacturing
, vol.59
, Issue.4 S
, pp. 1-28
-
-
|