The NISTmAb Reference Material 8671 lifecycle management and quality plan

AbstractComprehensive analysis of monoclonal antibody therapeutics involves an ever expanding cadre of technologies. Lifecycle-appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators in a pre-competitive space, an effort that may be facilitated by a widely available test metric. Biopharmaceutical quality materials, however, are often difficult to access and/or are protected by intellectual property rights. The NISTmAb, humanized IgG1κ Reference Material 8671 (RM 8671), has been established with the intent of filling that void. The NISTmAb embodies the quality and characteristics of a typical biopharmaceutical product, is widely available to the biopharmaceutical community, and is an open innovation tool for development and dissemination of results. The NISTmAb lifecyle management plan described herein provides a hierarchical strategy for maintenance of quality over time through rigorous method qualification detailed in additional submissions in the current publication series. The NISTmAb RM 8671 is a representative monoclonal antibody material and provides a means to continually evaluate current best practices, promote innovative approaches, and inform regulatory paradigms as technology advances. Graphical abstractThe NISTmAb Reference Material (RM) 8671 is intended to be an industry standard monoclonal antibody for pre-competitive harmonization of best practices and designing next generation characterization technologies for identity, quality, and stability testing.

[1]  Carlos Larriba,et al.  Ion Mobility and Mass Spectrometry Measurements of the Humanized IgGk NIST Monoclonal Antibody , 2015 .

[2]  Steven Kozlowski,et al.  Current and future issues in the manufacturing and development of monoclonal antibodies. , 2006, Advanced drug delivery reviews.

[3]  John E. Schiel,et al.  State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization: The NISTmAb Case Study , 2015 .

[4]  R D Josephs,et al.  Accurate quantification of impurities in pure peptide material - angiotensin I: Comparison of calibration requirements and method performance characteristics of liquid chromatography coupled to hybrid tandem mass spectrometry and linear ion trap high-resolution mass spectrometry. , 2015, Rapid communications in mass spectrometry : RCM.

[5]  John E. Schiel,et al.  Structural Elucidation of Post-Translational Modifications in Monoclonal Antibodies , 2015 .

[6]  John E. Schiel,et al.  Development of orthogonal NISTmAb size heterogeneity control methods , 2018, Analytical and Bioanalytical Chemistry.

[7]  Jose C. Menezes,et al.  A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry , 2017 .

[8]  D. Ecker,et al.  The therapeutic monoclonal antibody market , 2015, mAbs.

[9]  Sally S. Bruce.  The NIST Quality System for Measurement Services: A Look at its Past Decade and a Gaze toward its Future | NIST , 2013 .

[10]  John E. Schiel,et al.  Monoclonal Antibody Therapeutics: The Need for Biopharmaceutical Reference Materials , 2014 .

[11]  R. Guy,et al.  International Conference on Harmonisation , 2014 .

[12]  Dean C. Ripple,et al.  Correcting the Relative Bias of Light Obscuration and Flow Imaging Particle Counters , 2015, Pharmaceutical Research.

[13]  Xinjian Yan,et al.  In-Depth Characterization and Spectral Library Building of Glycopeptides in the Tryptic Digest of a Monoclonal Antibody Using 1D and 2D LC-MS/MS. , 2016, Journal of proteome research.

[14]  Robert G. Brinson,et al.  Application of Natural Isotopic Abundance ¹H-¹³C- and ¹H-¹⁵N-Correlated Two-Dimensional NMR for Evaluation of the Structure of Protein Therapeutics. , 2016, Methods in enzymology.

[15]  Gregory C. Flynn,et al.  Using Quality by Design Principles in Setting a Control Strategy for Product Quality Attributes , 2014 .

[16]  Pauline M. Rudd,et al.  Orthogonal Technologies for NISTmAb N-Glycan Structure Elucidation and Quantitation , 2015 .

[17]  Jared S. Bee,et al.  Characterization of Monoclonal Antibody Aggregates and Emerging Technologies , 2015 .

[18]  Yun Liu,et al.  Rheology of clustering protein solutions. , 2016, Biomicrofluidics.

[19]  R D Josephs,et al.  Impurity identification and determination for the peptide hormone angiotensin I by liquid chromatography–high-resolution tandem mass spectrometry and the metrological impact on value assignments by amino acid analysis , 2013, Analytical and Bioanalytical Chemistry.

[20]  John E. Schiel,et al.  State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. Defining the Next Generation of Analytical and Biophysical Techniques , 2015 .

[21]  Robert G. Brinson,et al.  2D 1HN, 15N Correlated NMR Methods at Natural Abundance for Obtaining Structural Maps and Statistical Comparability of Monoclonal Antibodies , 2015, Pharmaceutical Research.

[22]  H. Schimmel,et al.  Quantification of protein calibrants by amino acid analysis using isotope dilution mass spectrometry. , 2011, Analytical biochemistry.

[23]  John E. Schiel,et al.  Qualification of NISTmAb charge heterogeneity control assays , 2018, Analytical and Bioanalytical Chemistry.

[24]  John E. Schiel,et al.  The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability , 2018, Analytical and Bioanalytical Chemistry.

[25]  Kurt Brorson,et al.  Separation Methods and Orthogonal Techniques , 2015 .

[26]  Kurt Brorson,et al.  Determination of the NISTmAb Primary Structure , 2015 .

[27]  John E. Schiel,et al.  LC-MS/MS biopharmaceutical glycoanalysis: identification of desirable reference material characteristics , 2012, Analytical and Bioanalytical Chemistry.

[28]  John E. Schiel,et al.  State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 1. Monoclonal Antibody Therapeutics: Structure, Function, and Regulatory Space , 2014 .

[29]  John E. Schiel,et al.  Development of an LC-MS/MS peptide mapping protocol for the NISTmAb , 2018, Analytical and Bioanalytical Chemistry.

[30]  Rexmond Canning Cochrane,et al.  Measures for Progress: a History of the National Bureau of Standards , 1966 .

[31]  Richard S Rogers,et al.  Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics , 2015, mAbs.

[32]  Hendrik Emons,et al.  The new International Standard ISO 17034: general requirements for the competence of reference material producers , 2017, Accreditation and Quality Assurance.

[33]  Amit Katiyar,et al.  Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods. , 2016, Journal of pharmaceutical and biomedical analysis.

[34]  Dean C. Ripple,et al.  Protein Particles (0.1 υm to 100 υm) , 2015 .

[35]  Robert G. Brinson,et al.  Mapping monoclonal antibody structure by 2D 13C NMR at natural abundance. , 2015, Analytical chemistry.

[36]  Vicki Sifniotis,et al.  The state‐of‐play and future of antibody therapeutics☆ , 2017, Advanced drug delivery reviews.

[37]  Sumona Sarkar,et al.  Strategies for Achieving Measurement Assurance for Cell Therapy Products , 2016, Stem cells translational medicine.

[38]  Jeffrey W. Hudgens,et al.  Emerging Technologies To Assess the Higher Order Structure of Monoclonal Antibodies , 2015 .

[39]  Steven Westwood,et al.  Mass balance method for the SI value assignment of the purity of organic compounds. , 2013, Analytical chemistry.