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Determination of protein oxidation by mass spectrometry and method transfer to quality control

Journal of Chromatography A, 2006-08, Vol.1123 (2), p.189-198

2006

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Analysis of recombinant monoclonal antibody isoforms by electrospray ionization mass spectrometry as a strategy for streamlining characterization of recombinant monoclonal antibody charge heterogeneity

Analytical biochemistry, 2006, Vol.348 (1), p.24-39

2006

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Quality by design for biopharmaceuticals: principles and case studies

1st ed., 2009

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Detection and Characterization of Altered Conformations of Protein Pharmaceuticals Using Complementary Mass Spectrometry-Based Approaches

Analytical chemistry (Washington), 2008-10, Vol.80 (19), p.7473-7481

2008

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Proteomic Profiling of a High-Producing Chinese Hamster Ovary Cell Culture

Analytical chemistry (Washington), 2009-09, Vol.81 (17), p.7357-7362

2009

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Capillary Electrophoresis-Based Immunoassay for Cortisol in Serum

Analytical chemistry (Washington), 1995-02, Vol.67 (3), p.606-612

1995

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A comparison of three techniques for quantitative carbohydrate analysis used in characterization of therapeutic antibodies

Carbohydrate research, 2006-02, Vol.341 (3), p.410-419

2006

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Rapid quantitative capillary zone electrophoresis method for monitoring the micro-heterogeneity of an intact recombinant glycoprotein

Journal of Chromatography A, 2005-06, Vol.1079 (1), p.254-265

2005

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Rapid quantitative capillary zone electrophoresis method for monitoring the micro-heterogeneity of an intact recombinant glycoprotein: Separation science: past, present and future: a tribute to Csaba Horváth

Journal of chromatography, 2005, Vol.1079 (1-2), p.254-265

2005

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Strategies for locating disulfide bonds in a monoclonal antibody via mass spectrometry

Rapid communications in mass spectrometry, 1999-01, Vol.13 (24), p.2503-2510

1999

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Development of a chip‐based capillary gel electrophoresis method for quantification of a half‐antibody in immunoglobulin G 4 samples

Electrophoresis, 2004-11, Vol.25 (21-22), p.3890-3896

2004

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CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.9-30

2011

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CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.85-109

2011

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QbD FOR RAW MATERIALS

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.193-209

2011

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USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.53-84

2011

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QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.1-8

2011

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APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.127-142

2011

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PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.211-253

2011

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Rapid purification and monitoring of immunoglobulin M from ascites by perfusion ion-exchange chromatography

Journal of Chromatography A, 1996-08, Vol.743 (1), p.163-170

1996

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APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.175-192

2011

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APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.111-126

2011

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VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.143-159

2011

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EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.255-286

2011

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MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris

Quality by Design for Biopharmaceuticals, 2011, Vol.1, p.31-52

2011

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Determination of on-line differential refractive index and molecular weight via gradient HPLC interfaced with low-angle laser light scattering, ultraviolet, and refractive index detection

Analytical chemistry (Washington), 1993-02, Vol.65 (3), p.283-286

1993

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Determination of protein oxidation by mass spectrometry and method transfer to quality control

Analysis of recombinant monoclonal antibody isoforms by electrospray ionization mass spectrometry as a strategy for streamlining characterization of recombinant monoclonal antibody charge heterogeneity

Quality by design for biopharmaceuticals: principles and case studies

Detection and Characterization of Altered Conformations of Protein Pharmaceuticals Using Complementary Mass Spectrometry-Based Approaches

Proteomic Profiling of a High-Producing Chinese Hamster Ovary Cell Culture

Capillary Electrophoresis-Based Immunoassay for Cortisol in Serum

A comparison of three techniques for quantitative carbohydrate analysis used in characterization of therapeutic antibodies

Rapid quantitative capillary zone electrophoresis method for monitoring the micro-heterogeneity of an intact recombinant glycoprotein

Rapid quantitative capillary zone electrophoresis method for monitoring the micro-heterogeneity of an intact recombinant glycoprotein: Separation science: past, present and future: a tribute to Csaba Horváth

Strategies for locating disulfide bonds in a monoclonal antibody via mass spectrometry

Development of a chip‐based capillary gel electrophoresis method for quantification of a half‐antibody in immunoglobulin G 4 samples

CONSIDERATIONS FOR BIOTECHNOLOGY PRODUCT QUALITY BY DESIGN

CASE STUDY ON DEFINITION OF PROCESS DESIGN SPACE FOR A MICROBIAL FERMENTATION STEP

QbD FOR RAW MATERIALS

USING A RISK ASSESSMENT PROCESS TO DETERMINE CRITICALITY OF PRODUCT QUALITY ATTRIBUTES

QUALITY BY DESIGN: AN OVERVIEW OF THE BASIC CONCEPTS

APPLICATIONS OF DESIGN SPACE FOR BIOPHARMACEUTICAL PURIFICATION PROCESSES

PAT TOOLS FOR BIOLOGICS: CONSIDERATIONS AND CHALLENGES

Rapid purification and monitoring of immunoglobulin M from ascites by perfusion ion-exchange chromatography

APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT

APPLICATION OF QbD PRINCIPLES TO TANGENTIAL FLOW FILTRATION OPERATIONS

VIRAL CLEARANCE: A STRATEGY FOR QUALITY BY DESIGN AND THE DESIGN SPACE

EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL TECHNOLOGY

MOLECULAR DESIGN OF RECOMBINANT MALARIA VACCINES EXPRESSED BY Pichia pastoris

Determination of on-line differential refractive index and molecular weight via gradient HPLC interfaced with low-angle laser light scattering, ultraviolet, and refractive index detection

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