State-of-the-art and emerging trends in analytical approaches to pharmaceutical-product commercialization.

[1]  C. Capitain,et al.  Non-Targeted Screening Approaches for Profiling of Volatile Organic Compounds Based on Gas Chromatography-Ion Mobility Spectroscopy (GC-IMS) and Machine Learning , 2021, Molecules.

[2]  S. Jeong,et al.  Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification , 2021, Pharmaceutics.

[3]  Luke W. Arbogast,et al.  Principal Component Analysis of 1D ¹H Diffusion Edited NMR Spectra of Protein Therapeutics. , 2021, Journal of pharmaceutical sciences.

[4]  M. Wikström,et al.  Use of the 2D 1H-13C HSQC NMR Methyl Region to Evaluate the Higher Order Structural Integrity of Biopharmaceuticals , 2021, Molecules.

[5]  G. Gaza-Bulseco,et al.  “High‐risk” host cell proteins (HCPs): A multi‐company collaborative view , 2021, Biotechnology and bioengineering.

[6]  B. Sharma,et al.  Spatially offset Raman spectroscopy , 2021, Nature Reviews Methods Primers.

[7]  Z. Nagy,et al.  Real-time release testing of dissolution based on surrogate models developed by machine learning algorithms using NIR spectra, compression force and particle size distribution as input data. , 2021, International journal of pharmaceutics.

[8]  Izabela Zaborowska,et al.  Tracking the Behavior of Monoclonal Antibody Product Quality Attributes Using a Multi-Attribute Method Workflow. , 2021, Journal of the American Society for Mass Spectrometry.

[9]  A. Pfenninger,et al.  Automated mass spectrometry multi-attribute method analyses for process development and characterization of mAbs. , 2021, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[10]  I. Lundström,et al.  Real-Time Nanoplasmonic Sensor for IgG Monitoring in Bioproduction , 2020, Processes.

[11]  J. Glick,et al.  Bioanalytical Challenges in Support of Complex Modalities of Antibody-Based Therapeutics , 2020, The AAPS Journal.

[12]  Noah J. Wichrowski,et al.  An Overview of Drug Substance Manufacturing Processes , 2020, AAPS PharmSciTech.

[13]  Jukka Rantanen,et al.  Image-Based Artificial Intelligence Methods for Product Control of Tablet Coating Quality , 2020, Pharmaceutics.

[14]  Daniel Markl,et al.  Review of Real-Time Release Testing of Pharmaceutical Tablets: State-of-the Art, Challenges and Future Perspective. , 2020, International journal of pharmaceutics.

[15]  V. Loladze,et al.  Rapid Intact Mass Based Multi-Attribute Method in Support of mAb Upstream Process Development. , 2020, Journal of biotechnology.

[16]  M. Honing,et al.  Probing Protein Denaturation during Size-Exclusion Chromatography Using Native Mass Spectrometry , 2020, Analytical chemistry.

[17]  Eric Carter,et al.  A Comparison of Background Membrane Imaging versus Flow Technologies for Subvisible Particle Analysis of Biologics. , 2020, International journal of pharmaceutics.

[18]  John F. Valliere-Douglass,et al.  Native size-exclusion chromatography-mass spectrometry: suitability for antibody–drug conjugate drug-to-antibody ratio quantitation across a range of chemotypes and drug-loading levels , 2019, mAbs.

[19]  E. Gentalen,et al.  A novel microchip‐based imaged CIEF‐MS system for comprehensive characterization and identification of biopharmaceutical charge variants , 2019, Electrophoresis.

[20]  C. E. Sänger-van de Griend CE‐SDS method development, validation, and best practice—An overview , 2019, Electrophoresis.

[21]  Ho Young Lee,et al.  Characterization of a single reporter-gene potency assay for T-cell-dependent bispecific molecules , 2019, mAbs.

[22]  S. Bergelson,et al.  A Digestion-free Method for Quantification of Residual Host Cell DNA in rAAV Gene Therapy Products , 2019, Molecular therapy. Methods & clinical development.

[23]  Zhongqi Zhang,et al.  Reliable LC-MS Multiattribute Method for Biotherapeutics by Run-Time Response Calibration. , 2019, Analytical chemistry.

[24]  Ryan M. Evans,et al.  Enabling adoption of 2D-NMR for the higher order structure assessment of monoclonal antibody therapeutics , 2018, mAbs.

[25]  Timothy J. N. Watson,et al.  Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities , 2018, Journal of Pharmaceutical Innovation.

[26]  Melinda M. Mulvihill,et al.  Quantitative Determination of Protein-Ligand Affinity by Size Exclusion Chromatography Directly Coupled to High-Resolution Native Mass Spectrometry. , 2018, Analytical chemistry.

[27]  M. Otsuka,et al.  Real-time monitoring of the tablet-coating process by near-infrared spectroscopy - Effects of coating polymer concentrations on pharmaceutical properties of tablets , 2018, Journal of Drug Delivery Science and Technology.

[28]  Eric Ziemons,et al.  Development and validation of an in‐line NIR spectroscopic method for continuous blend potency determination in the feed frame of a tablet press , 2018, Journal of pharmaceutical and biomedical analysis.

[29]  J. Wypych,et al.  Direct mass spectrometric characterization of disulfide linkages , 2018, mAbs.

[30]  Elizabeth H. Peuchen,et al.  Sensitive and fast characterization of site-specific protein glycosylation with capillary electrophoresis coupled to mass spectrometry. , 2018, Talanta.

[31]  Mike Denham,et al.  Real time release testing of tablet content and content uniformity. , 2018, International journal of pharmaceutics.

[32]  Shobha Purushothama,et al.  Emerging technologies for biotherapeutic bioanalysis from a high-throughput and multiplexing perspective: insights from an AAPS emerging technology action program committee. , 2018, Bioanalysis.

[33]  Qiangwei Xia,et al.  Capillary Isoelectric Focusing-Mass Spectrometry Method for the Separation and Online Characterization of Intact Monoclonal Antibody Charge Variants. , 2018, Analytical chemistry.

[34]  O. Mayboroda,et al.  Sialic acid linkage differentiation of glycopeptides using capillary electrophoresis – electrospray ionization – mass spectrometry , 2017, Scientific Reports.

[35]  M. Hussain,et al.  A Droplet Digital PCR Method for CHO Host Residual DNA Quantification in Biologic Drugs , 2017 .

[36]  Fay Betsou,et al.  Method Validation for Extraction of Nucleic Acids from Peripheral Whole Blood. , 2016, Biopreservation and biobanking.

[37]  Fernando Muzzio,et al.  Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC). , 2016, International journal of pharmaceutics.

[38]  David G. Grier,et al.  Holographic Characterization of Protein Aggregates. , 2016, Journal of pharmaceutical sciences.

[39]  Brock F. Binkowski,et al.  NanoLuc Complementation Reporter Optimized for Accurate Measurement of Protein Interactions in Cells. , 2016, ACS chemical biology.

[40]  Karen Roberts,et al.  Implementation and Challenges of Direct Acoustic Dosing into Cell-Based Assays , 2016, Journal of laboratory automation.

[41]  C. De Bleye,et al.  Active content determination of pharmaceutical tablets using near infrared spectroscopy as Process Analytical Technology tool. , 2015, Talanta.

[42]  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.

[43]  Susan Callahan,et al.  A framework for real‐time glycosylation monitoring (RT‐GM) in mammalian cell culture , 2015, Biotechnology and bioengineering.

[44]  L. Poppe,et al.  On the Analytical Superiority of 1D NMR for Fingerprinting the Higher Order Structure of Protein Therapeutics Compared to Multidimensional NMR Methods. , 2015, Analytical chemistry.

[45]  Thomas De Beer,et al.  Process Analytical Technology for continuous manufacturing of solid-dosage forms , 2015 .

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

[47]  P. Obrdlík,et al.  Direct real-time quantitative PCR for measurement of host-cell residual DNA in therapeutic proteins. , 2014, Journal of pharmaceutical and biomedical analysis.

[48]  Pierre-François Chavez,et al.  Towards a real time release approach for manufacturing tablets using NIR spectroscopy. , 2014, Journal of pharmaceutical and biomedical analysis.

[49]  G. K. Raju,et al.  Understanding Pharmaceutical Quality by Design , 2014, The AAPS Journal.

[50]  R. Forbes,et al.  Impact of Quality by Design in Process Development on the Analytical Control Strategy for a Small-Molecule Drug Substance , 2013, Journal of Pharmaceutical Innovation.

[51]  L. Poppe,et al.  Profiling formulated monoclonal antibodies by (1)H NMR spectroscopy. , 2013, Analytical chemistry.

[52]  Ying Shi,et al.  Advantages of CE-SDS over SDS-PAGE in mAb purity analysis , 2012 .

[53]  Valerie L. Anderson,et al.  Transmission electron microscopy characterization of fluorescently labelled amyloid β 1-40 and α-synuclein aggregates , 2011, BMC biotechnology.

[54]  Lipika Chablani,et al.  Inline Real-Time Near-Infrared Granule Moisture Measurements of a Continuous Granulation–Drying–Milling Process , 2011, AAPS PharmSciTech.

[55]  Wee Chew,et al.  Trends in process analytical technology , 2010 .

[56]  Wei Chen,et al.  Modeling of pan coating processes: Prediction of tablet content uniformity and determination of critical process parameters. , 2010, Journal of pharmaceutical sciences.

[57]  M. Blanco,et al.  Content uniformity and tablet hardness testing of intact pharmaceutical tablets by near infrared spectroscopy: A contribution to process analytical technologies , 2006 .

[58]  Marc S. Lewis,et al.  Modern analytical ultracentrifugation in protein science: A tutorial review , 2002, Protein science : a publication of the Protein Society.

[59]  W. N. Burnette,et al.  "Western blotting": electrophoretic transfer of proteins from sodium dodecyl sulfate--polyacrylamide gels to unmodified nitrocellulose and radiographic detection with antibody and radioiodinated protein A. , 1981, Analytical biochemistry.

[60]  U. K. Laemmli,et al.  Cleavage of Structural Proteins during the Assembly of the Head of Bacteriophage T4 , 1970, Nature.

[61]  J. Porath,et al.  Gel Filtration: A Method for Desalting and Group Separation , 1959, Nature.

[62]  M. Wikström,et al.  A comparison between emerging and current biophysical methods for the assessment of higher order structure of biopharmaceuticals. , 2019, Journal of pharmaceutical sciences.

[63]  T. Menzen,et al.  Backgrounded Membrane Imaging (BMI) for High-Throughput Characterization of Subvisible Particles During Biopharmaceutical Drug Product Development. , 2019, Journal of pharmaceutical sciences.

[64]  Patrick G. Swann,et al.  A View on the Importance of “Multi-Attribute Method” for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy , 2017, The AAPS Journal.

[65]  J. Lamerdin,et al.  R Side Accelerating Biologic and Biosimilar Drug Development Ready-to-Use , Cell-Based Assays for Potency and Lot-Release Testing , 2015 .

[66]  Ralf Weiskirchen,et al.  MAKERGAUL: an innovative MAK2-based model and software for real-time PCR quantification. , 2014, Clinical biochemistry.

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

[68]  Ryan M. O’Donnell,et al.  Pharmaceutical applications of ion mobility spectrometry , 2008 .