-
2
-
-
84863537359
-
Distinctions between Analytical and Bioanalytical Test Methods
-
Ritter NM. Distinctions Between Analytical and Bioanalytical Test Methods. BioProcess Int. 9(3) 2011: 80.
-
(2011)
BioProcess Int.
, vol.9
, Issue.3
, pp. 80
-
-
Ritter, N.M.1
-
3
-
-
33747470105
-
CMC Strategy Forum Report: Analysis and Structure Characterization of Monoclonal Antibodies
-
Schenerman MA, et al. CMC Strategy Forum Report: Analysis and Structure Characterization of Monoclonal Antibodies. BioProcess Int. 2(2) 2004: 42-52.
-
(2004)
BioProcess Int.
, vol.2
, Issue.2
, pp. 42-52
-
-
Schenerman, M.A.1
-
4
-
-
46649115901
-
Defining Your Product Profile and Maintaining Control over It, Part 1: Session One of the WCBP CMC Strategy Forum, 19-20 July 2004
-
Simmerman H, Donnelly RP. Defining Your Product Profile and Maintaining Control Over It, Part 1: Session One of the WCBP CMC Strategy Forum, 19-20 July 2004. BioProcess Int. 3(6) 2005: 32-40.
-
(2005)
BioProcess Int.
, vol.3
, Issue.6
, pp. 32-40
-
-
Simmerman, H.1
Donnelly, R.P.2
-
5
-
-
37349012594
-
Defining Your Product Profile and Maintaining Control over It, Part 2: Challenges of Monitoring Host Cell Protein Impurities
-
Champion K, et al. Defining Your Product Profile and Maintaining Control Over It, Part 2: Challenges of Monitoring Host Cell Protein Impurities. BioProcess Int. 3(8) 2005: 52-57.
-
(2005)
BioProcess Int.
, vol.3
, Issue.8
, pp. 52-57
-
-
Champion, K.1
-
6
-
-
34347206089
-
Defining Your Product Profile and Maintaining Control over It, Part 3: Product-Related Impurities
-
Boerner R, Clouse K. Defining Your Product Profile and Maintaining Control Over It, Part 3: Product-Related Impurities. BioProcess Int. 3(9) 2005: 50-56.
-
(2005)
BioProcess Int.
, vol.3
, Issue.9
, pp. 50-56
-
-
Boerner, R.1
Clouse, K.2
-
7
-
-
34347206089
-
Defining Your Product Profile and Maintaining Control over It, Part 4: Tackling Aggregates
-
Brorson K, Phillips J. Defining Your Product Profile and Maintaining Control Over It, Part 4: Tackling Aggregates. BioProcess Int. 3(10) 2005: 50-54.
-
(2005)
BioProcess Int.
, vol.3
, Issue.10
, pp. 50-54
-
-
Brorson, K.1
Phillips, J.2
-
8
-
-
57749200041
-
Managing the Analytical Lifecycle for Biotechnology Products: A Journey from Method Development to Validation, Part One
-
Apostol I, Kelner DN. Managing the Analytical Lifecycle for Biotechnology Products: A Journey from Method Development to Validation, Part One. BioProcess Int. 6(8) 2008: 12-19.
-
(2008)
BioProcess Int.
, vol.6
, Issue.8
, pp. 12-19
-
-
Apostol, I.1
Kelner, D.N.2
-
9
-
-
57749200041
-
Managing the Analytical Lifecycle for Biotechnology Products: A Journey from Method Development to Validation, Part Two
-
Apostol I, Kelner DN. Managing the Analytical Lifecycle for Biotechnology Products: A Journey from Method Development to Validation, Part Two. BioProcess Int. 6(9) 2008: 12-19.
-
(2008)
BioProcess Int.
, vol.6
, Issue.9
, pp. 12-19
-
-
Apostol, I.1
Kelner, D.N.2
-
10
-
-
77951996295
-
Establishing Potency Specifications for Antigen Vaccines: Clinical Validation of Statistically Derived Release and Stability Specifications
-
Capen R, et al. Establishing Potency Specifications for Antigen Vaccines: Clinical Validation of Statistically Derived Release and Stability Specifications. BioProcess Int. 5(5) 2007: 30-42.
-
(2007)
BioProcess Int.
, vol.5
, Issue.5
, pp. 30-42
-
-
Capen, R.1
-
11
-
-
79955849283
-
Quality by Design and the New Process Validation Guidance
-
Scott C. Quality By Design and the New Process Validation Guidance. BioProcess Int. 9(5) 2011: 14-21.
-
(2011)
BioProcess Int.
, vol.9
, Issue.5
, pp. 14-21
-
-
Scott, C.1
-
12
-
-
84863556393
-
Analytical Instrument Qualification: Standardization on the 4Q Model
-
Winter W. Analytical Instrument Qualification: Standardization on the 4Q Model. BioProcess Int. 4(9) 2006: 46-50.
-
(2006)
BioProcess Int.
, vol.4
, Issue.9
, pp. 46-50
-
-
Winter, W.1
-
13
-
-
47149089612
-
What Is Test Method Qualification?
-
Proceedings of the WCBP CMC Strategy Forum, 24 July 2003
-
Ritter N, et al. What Is Test Method Qualification? Proceedings of the WCBP CMC Strategy Forum, 24 July 2003. BioProcess Int. 2(8) 2004: 32-46.
-
(2004)
BioProcess Int.
, vol.2
, Issue.8
, pp. 32-46
-
-
Ritter, N.1
-
14
-
-
57749086341
-
Trends in Analytical Instrument Qualification
-
Smith P. Trends in Analytical Instrument Qualification. BioProcess Int. 5(9) 2007: 30-38.
-
(2007)
BioProcess Int.
, vol.5
, Issue.9
, pp. 30-38
-
-
Smith, P.1
-
15
-
-
77953444196
-
Assay Validation for Rapid Detection of Mycoplasma Contamination
-
Brown DB, et al. Assay Validation for Rapid Detection of Mycoplasma Contamination. BioProcess Int. 7(4) 2009: 30-40.
-
(2009)
BioProcess Int.
, vol.7
, Issue.4
, pp. 30-40
-
-
Brown, D.B.1
-
16
-
-
84863556120
-
Analytical Methods for Biologics
-
Scott C. Analytical Methods for Biologics. BioProcess Int. 5(2) 2007: S35-S38.
-
(2007)
BioProcess Int.
, vol.5
, Issue.2
-
-
Scott, C.1
-
17
-
-
84863546440
-
Structural Signatures for Analysis and Characterization of Biological Products
-
Chait A, Zaslavsky B. Structural Signatures for Analysis and Characterization of Biological Products. BioProcess Int. 1(2) 2003: 60-67.
-
(2003)
BioProcess Int.
, vol.1
, Issue.2
, pp. 60-67
-
-
Chait, A.1
Zaslavsky, B.2
-
18
-
-
34748905683
-
DSA-FACE: High-Throughput Analysis of the N-Glycans of NS0 Cell-Secreted Antibodies
-
Defrancq L, et al. DSA-FACE: High-Throughput Analysis of the N-Glycans of NS0 Cell-Secreted Antibodies. BioProcess Int. 2(8) 2004: 60-68.
-
(2004)
BioProcess Int.
, vol.2
, Issue.8
, pp. 60-68
-
-
Defrancq, L.1
-
19
-
-
53149138331
-
Criteria for Selection of IgG Isotype and Glycoform Antibody Therapeutics
-
Jefferis R. Criteria for Selection of IgG Isotype and Glycoform Antibody Therapeutics. BioProcess Int. 4(9) 2006: 40-43.
-
(2006)
BioProcess Int.
, vol.4
, Issue.9
, pp. 40-43
-
-
Jefferis, R.1
-
20
-
-
60849109435
-
High-Throughput Glycoanalysis for Biopharmaceutical Development and Manufacturing
-
Rosenfeld R, et al. High-Throughput Glycoanalysis for Biopharmaceutical Development and Manufacturing. BioProcess Int. 5(2) 2007: 38-47.
-
(2007)
BioProcess Int.
, vol.5
, Issue.2
, pp. 38-47
-
-
Rosenfeld, R.1
-
21
-
-
84863546441
-
Higher-Order Structure Comparison of Proteins Derived from Different Clones or Processes
-
Bierau H, et al. Higher-Order Structure Comparison of Proteins Derived from Different Clones or Processes. BioProcess Int. 6(8) 2008: 52-59.
-
(2008)
BioProcess Int.
, vol.6
, Issue.8
, pp. 52-59
-
-
Bierau, H.1
-
22
-
-
77957086628
-
Sequence Variant Analysis Using Peptide Mapping by LC-MS/MS
-
Que AH, et al. Sequence Variant Analysis Using Peptide Mapping By LC-MS/MS. BioProcess Int. 8(8) 2010: 52-60.
-
(2010)
BioProcess Int.
, vol.8
, Issue.8
, pp. 52-60
-
-
Que, A.H.1
-
23
-
-
79955134302
-
The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
-
Wei Z, et al. The Role of Higher-Order Structure in Defining Biopharmaceutical Quality. BioProcess Int. 9(4) 2011: 58-66.
-
(2011)
BioProcess Int.
, vol.9
, Issue.4
, pp. 58-66
-
-
Wei, Z.1
-
24
-
-
81055126364
-
Imaged Capillary Isoelectric Focusing for Charge-Variant Analysis of Biopharmaceuticals
-
Michels DA, Salas-Solano O, Felten C. Imaged Capillary Isoelectric Focusing for Charge-Variant Analysis of Biopharmaceuticals. BioProcess Int. 9(10) 2011: 48-54.
-
(2011)
BioProcess Int.
, vol.9
, Issue.10
, pp. 48-54
-
-
Michels, D.A.1
Salas-Solano, O.2
Felten, C.3
-
25
-
-
36248985677
-
Protein Concentration Determination: The Achilles Heel of GMP?
-
Lundblad RL, Price NC. Protein Concentration Determination: The Achilles Heel of GMP? BioProcess Int. 2(1) 2004: 38-47.
-
(2004)
BioProcess Int.
, vol.2
, Issue.1
, pp. 38-47
-
-
Lundblad, R.L.1
Price, N.C.2
-
26
-
-
84863541176
-
A 96-Well Plate Assay for Relative Monoclonal Antibody Titers
-
Rau TD, Balcarcel RR. A 96-Well Plate Assay for Relative Monoclonal Antibody Titers. BioProcess Int. 4(3) 2006: 42-48.
-
(2006)
BioProcess Int.
, vol.4
, Issue.3
, pp. 42-48
-
-
Rau, T.D.1
Balcarcel, R.R.2
-
27
-
-
84863543012
-
Determining Endotoxin Levels and Inhibition and Enhancement of the Endotoxin Reaction
-
Cronholm K, Johansson M. Determining Endotoxin Levels and Inhibition and Enhancement of the Endotoxin Reaction. BioProcess Int. 5(4) 2007: 78-83.
-
(2007)
BioProcess Int.
, vol.5
, Issue.4
, pp. 78-83
-
-
Cronholm, K.1
Johansson, M.2
-
28
-
-
33644744918
-
Assays for Controlling Host-Cell Impurities in Biopharmaceuticals
-
Wolter T, Richter A. Assays for Controlling Host-Cell Impurities in Biopharmaceuticals. BioProcess Int. 2(2) 2005: 40-46.
-
(2005)
BioProcess Int.
, vol.2
, Issue.2
, pp. 40-46
-
-
Wolter, T.1
Richter, A.2
-
29
-
-
83555169371
-
High-Throughput and Quantitative Detection of Residual NS0 and CHO Host-Cell Genomic DNA
-
Venable D, et al. High-Throughput and Quantitative Detection of Residual NS0 and CHO Host-Cell Genomic DNA. BioProcess Int. 4(6) 2007: 56-61.
-
(2007)
BioProcess Int.
, vol.4
, Issue.6
, pp. 56-61
-
-
Venable, D.1
-
30
-
-
83555170908
-
Performance Characteristics of Host-Cell DNA Quantification Methods
-
Mehta S, Keer JT. Performance Characteristics of Host-Cell DNA Quantification Methods. BioProcess Int. 4(9) 2007: 44-58.
-
(2007)
BioProcess Int.
, vol.4
, Issue.9
, pp. 44-58
-
-
Mehta, S.1
Keer, J.T.2
-
31
-
-
77953469350
-
Improved HCP Quantitation by Minimizing Antibody Cross-Reactivity to Target Proteins
-
Wang X, et al. Improved HCP Quantitation By Minimizing Antibody Cross-Reactivity to Target Proteins. BioProcess Int. 8(1) 2010: 18-24.
-
(2010)
BioProcess Int.
, vol.8
, Issue.1
, pp. 18-24
-
-
Wang, X.1
-
32
-
-
77953440865
-
Are Generic HCP Assays Outdated?
-
Schwertner D, Kirchner M. Are Generic HCP Assays Outdated? BioProcess Int. 8(5) 2010: 56-62.
-
(2010)
BioProcess Int.
, vol.8
, Issue.5
, pp. 56-62
-
-
Schwertner, D.1
Kirchner, M.2
-
33
-
-
79955150105
-
Development of an in-House, Process-Specific ELISA for Detecting HCP in a Therapeutic Antibody, Part 1
-
Savino E, et al. Development of an In-House, Process-Specific ELISA for Detecting HCP in a Therapeutic Antibody, Part 1. BioProcess Int. 9(3) 2011: 38-47.
-
(2011)
BioProcess Int.
, vol.9
, Issue.3
, pp. 38-47
-
-
Savino, E.1
-
34
-
-
79955150105
-
Development of an in-House, Process-Specific ELISA for Detecting HCP in a Therapeutic Antibody, Part 2
-
Savino E, et al. Development of an In-House, Process-Specific ELISA for Detecting HCP in a Therapeutic Antibody, Part 2. BioProcess Int. 9(4) 2011: 68-75.
-
(2011)
BioProcess Int.
, vol.9
, Issue.4
, pp. 68-75
-
-
Savino, E.1
-
35
-
-
84863160063
-
Host Cellular Protein Quantification
-
Liu N, et al. Host Cellular Protein Quantification. BioProcess Int. 10(2) 2012: 44-50.
-
(2012)
BioProcess Int.
, vol.10
, Issue.2
, pp. 44-50
-
-
Liu, N.1
-
36
-
-
33846689773
-
Lot Release and Characterization Testing of Live-Virus-Based Vaccines and Gene Therapy Products, Part 1
-
Gombold J, et al. Lot Release and Characterization Testing of Live-Virus-Based Vaccines and Gene Therapy Products, Part 1. BioProcess Int. 4(4) 2006: 46-54.
-
(2006)
BioProcess Int.
, vol.4
, Issue.4
, pp. 46-54
-
-
Gombold, J.1
-
37
-
-
33846689773
-
Lot Release and Characterization Testing of Live-Virus-Based Vaccines and Gene Therapy Products, Part 2
-
Gombold J, et al. Lot Release and Characterization Testing of Live-Virus-Based Vaccines and Gene Therapy Products, Part 2. BioProcess Int. 4(5) 2006: 56-65.
-
(2006)
BioProcess Int.
, vol.4
, Issue.5
, pp. 56-65
-
-
Gombold, J.1
-
38
-
-
77951491160
-
Demonstrating Comparability for Well-Characterized Biotechnology Products
-
Towns J, Webber K. Demonstrating Comparability for Well-Characterized Biotechnology Products. BioProcess Int. 6(2) 2008: 32-43.
-
(2008)
BioProcess Int.
, vol.6
, Issue.2
, pp. 32-43
-
-
Towns, J.1
Webber, K.2
-
39
-
-
77953440038
-
The Time Has Come for Automation in Bioprocessing
-
Scott C, McLeod LD. The Time Has Come for Automation in Bioprocessing. BioProcess Int. 8(2) 2010: 16-25.
-
(2010)
BioProcess Int.
, vol.8
, Issue.2
, pp. 16-25
-
-
Scott, C.1
McLeod, L.D.2
-
40
-
-
77953391087
-
Automated Liquid Handlers As Sources of Error
-
Albert KJ. Automated Liquid Handlers As Sources of Error. BioProcess Int. 7(6) 2009: 56-60.
-
(2009)
BioProcess Int.
, vol.7
, Issue.6
, pp. 56-60
-
-
Albert, K.J.1
-
41
-
-
68949091057
-
Emerging Analytical Technologies for Biotherapeutics Development
-
Krishnamurthy R, et al. Emerging Analytical Technologies for Biotherapeutics Development. BioProcess Int. 6(5) 2008: 32-42.
-
(2008)
BioProcess Int.
, vol.6
, Issue.5
, pp. 32-42
-
-
Krishnamurthy, R.1
-
43
-
-
34548456274
-
A Survey of Bioassays in the Biopharmaceutical Industry
-
Robinson CJ, et al. A Survey of Bioassays in the Biopharmaceutical Industry. BioProcess Int. 4(6) 2006: 24-36.
-
(2006)
BioProcess Int.
, vol.4
, Issue.6
, pp. 24-36
-
-
Robinson, C.J.1
-
44
-
-
77955400039
-
The Roles of Bioactivity Assays in Lot Release and Stability Testing
-
Rieder N, et al. The Roles of Bioactivity Assays in Lot Release and Stability Testing. BioProcess Int. 8(6) 2010: 33-42.
-
(2010)
BioProcess Int.
, vol.8
, Issue.6
, pp. 33-42
-
-
Rieder, N.1
-
45
-
-
77957016754
-
Assessing Nonparallelism in Bioassays
-
Das RG, Robinson CJ. Assessing Nonparallelism in Bioassays. BioProcess Int. 6(10) 2008: 36-56.
-
(2008)
BioProcess Int.
, vol.6
, Issue.10
, pp. 36-56
-
-
Das, R.G.1
Robinson, C.J.2
-
46
-
-
77953379490
-
Accelerating Bioassay Transfer in a GMP Environment
-
Menendez AT. Accelerating Bioassay Transfer in a GMP Environment. BioProcess Int. 7(11) 2009: 26-33.
-
(2009)
BioProcess Int.
, vol.7
, Issue.11
, pp. 26-33
-
-
Menendez, A.T.1
-
47
-
-
77955411444
-
Practical Considerations for DoE Implementation in Quality by Design
-
Shivhare M, McCreath G. Practical Considerations for DoE Implementation in Quality By Design. BioProcess Int. 8(6) 2010: 22-30.
-
(2010)
BioProcess Int.
, vol.8
, Issue.6
, pp. 22-30
-
-
Shivhare, M.1
McCreath, G.2
-
48
-
-
17144379163
-
HACCP: A Process Validation Tool for Ensuring Quality of Biotech and Pharmaceutical Products
-
Vega-Mercado H, et al. HACCP: A Process Validation Tool for Ensuring Quality of Biotech and Pharmaceutical Products. BioProcess Int. 1(5) 2003: 50-57.
-
(2003)
BioProcess Int.
, vol.1
, Issue.5
, pp. 50-57
-
-
Vega-Mercado, H.1
-
49
-
-
77953910060
-
Operations and Quality Systems: Building in Success
-
Montgomery SA. Operations and Quality Systems: Building in Success. BioProcess Int. 4(3) 2006: S58-S71.
-
(2006)
BioProcess Int.
, vol.4
, Issue.3
-
-
Montgomery, S.A.1
|