Key factors influencing ADME properties of therapeutic proteins: A need for ADME characterization in drug discovery and development
Tibbitts, J et al. mAbs. 2015  
Antibody-drug conjugates nonclinical support: from early to late nonclinical bioanalysis using ligand-binding assays
Kumar, S et al. Bioanalysis (2015) 7(13), 1605-1617. 2015  
Antibody–drug conjugate bioanalysis using LB-LC–MS/MS hybrid assays: strategies, methodology and correlation to ligand-binding
Wang, J et al. Bioanalysis 2016 Jul;8(13):1383-401. 2016  
Validation of an integrated series of ligand-binding assays for the quantitative determination of antibody-drug conjugates in biological matrices
Myler, H et al. Bioanalysis (2016) 8(6), 519-531. 2016  
Calculated conjugated payload from immunoassay and LC-MS intact protein analysis measurements of antibody-drug conjugate
Rago, B et al. Bioanalysis 2016 Nov;8(21):2205-2217. 2016  
Site Selection: a Case Study in the Identification of Optimal Cysteine Engineered Antibody Drug Conjugates
Tumey LN, et al. The AAPS Journal April 24. 2017  
Formation of Composite Endothelial Cell-Mesenchymal Stem Cell Islets A Novel Approach to Promote Islet Revascularization
Johansson, U et al. Diabetes 2008, 57 (9) 2393-2401. 2008  
Simultaneous Multiple Immunoassays in a Compact Disc-Shaped Microfluidic Device Based on Centrifugal Force
Honda, N et al. Clin Chem 2005, 51 (10) 1955-1961. 2005  
CT60 genotype does not affect CTLA-4 isoform expression despite association to T1D and AITD in northern Sweden
Mayans, S et al. BMC Medical Genetics 2007, 8:3. 2007  
Regulatory T cell-associated activity in photopheresis-induced immune tolerance in recent onset type 1 diabetes children
Jonson, C-O. Clin Exp Immunol. 2008, 153 (2) 174-181. 2008  
Effects of Alcohol Consumption on the Allergen-Specific Immune Response in Mice
Linneberg, A et al. Alcoholism: Clin and Expl Res. 2008, 32 (3) 553-557. 2008  
Design and testing of a microfluidic biochip for cytokine enzyme-linked immunosorbent assay
He, H et al. Biomicrofluidics. 2009, 3 (2) 22401. 2009  
Increased sample volume improves ability to quantify cytokines in Gyrolab Bioaffy 1000
Clizbe, D et al. Poster. 2009  
Evaluation of in vitro and in vivo tau phosphorylation using the Gyros immunoassay platform
Thomas, AK et al. Society for neurosciences meeting November 2010. 2010  
Expansion and Activation Kinetics of Immune Cells during Early Phase of GVHD in Mouse Model Based on Chemotherapy Conditioning
Sadeghi, B et al. Clin Dev Immunol. 2010, 142943. doi: 10.1155/2010/142943. Epub 2010 Dec 21. 2010  
Resolvin E1 reduces proinflammatory markers in human pancreatic islets in vitro
Lund, T et al. Exp Clin Endocrinol Diabetes. 2010, 118(4) 237-44. 2010  
Shb deficient mice display an augmented TH2 response in peripheral CD4+ T cells
Gustafsson, K et al. BMC Immunol. 2011 12:3. doi: 10.1186/1471-2172-12-3. 2011  
Development and validation of an alpha fetoprotein immunoassay using Gyros technology.
Given, AM et al. J Pharm Biomed Anal. 2012 May;64-65:8-15. 2012  
AZD1080, a novel GSK3 inhibitor, rescues synaptic plasticity deficits in rodent brain and exhibits peripheral target engagement in humans.
Georgievska, B et al. J Neurochem. 2013 May;125(3):446-56. 2013  
Interleukin-31: its role in canine pruritus and naturally occurring canine atopic dermatitis
Gonzales, AJ et al. Vet Dermatol 2013, 24: 48-e12. 2013  
Urine Urea Impacts the Accuracy of Soluble Vascular Cell Adhesion Molecule 1 (sVCAM-1) Urinary Immunoassay
Shen,C et al. AAPS, Poster. 2014  
Characterization of Human Organ Donors Testing Positive for Type 1 Diabetes-Associated Autoantibodies
Wiberg, A et al. Clinical Experimental Immunology 2015 Dec;182(3):278-88. 2015  
Delivering rhFGF-18 via a bilayer collagen membrane to enhance microfracture treatment of chondral defects in a large animal model
Howard, D et al. Journal of Orthopaedic Research, Accepted 7 February 2015. 2015  
Induction of miR-132 and miR-212 Expression by Glucagon-Like Peptide 1 (GLP-1) in Rodent and Human Pancreatic Beta-Cells
Shang, J et al. Molecular Endocrinology, doi: 10.1210/me.2014-1335. 2015  
Evaluation of highly sensitive immunoassay technologies for quantitative measurements of sub-pg/mL levels of cytokines in human serum
Yeung, D et al. Journal of Immunological Methods 2016 Oct;437:53-63. 2016  
Application Report 204: Insulin quantification:save sample and increase efficiency
Inganäs, M. Gyros Application Report. 2011  
Evaluation of Tau Phosphorylation using a Non-Traditional Immunoassay Platform
Boyer, S et al. 4th Annual European Gyrolab Seminar. 2010  
The Rb1 fraction of ginseng elicits a balanced Th1 and Th2 immune reponse
Rivera, E et al. Vaccine 2005, 23 (46-47) 5411-5419. 2005  
Analyses of AKT and PDGF receptor expression and activation in human tumors
Paulsen, J. PhD thesis ISBN: 978-91-7409-504-3. 2009  
Minimising Volume, Maximising Returns
Hannam, S et al. European Pharmaceutical Review, Discovery Technology, Spring 2010. 2010  
Application Report 207: Miniaturizing immunoassays for improved performance
Inganäs, M. Gyros Application Report. 2011  
Assessment of Preclinical Liver and Skeletal Muscle Biomarkers Following Clofibrate Administration in Wistar Rats
Maliver, P et al. Toxicologic Pathology 1-20. 2017  
Immunogenicity monitoring during preclinical development of Nanobodies¨: comparing assay formats and species matrices
Poelmans, S et al. AAPS. 2010  
Development of an automated ADA immunoassay with integrated acid dissociation and neutralization
Eckersten, A et al. Poster. 2011  
Comparative immunogenicity assessment: a critical consideration for biosimilar development
Liu, PM et al. Bioanalysis (2015) 7(3). 2015  
Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility
Wadhwa, M et al. Biologicals (2015) 1-9. 2015  
Strategies to compare clinical antitherapeutic antibody data when changing assay platforms: a case study
Qui, ZJ et al. Bioanalysis (2015) 7(14) , 1775-1783. 2015  
Evaluation of Multiple Immunoassay Technology Platforms to Select the Anti-Drug Antibody Assay Exhibiting the Most Appropriate Drug and Target Tolerance
Collet-Brose, J et al. Journal of Immunology Research. 2016  
A novel strategy to reduce the immunogenicity of biological therapies
Somerfield, J et al. J Immunology 2010, 185 (1) 763-768. 2010  
Utility of the Gyros Gyrolab in Research and DMPK - an automated ligand binding assay platform
Brady, K. PPT presentation. 2010  
Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies
Partridge, M A et al. Journal of Immunology Research . 2016  
Automated protein quantification in bioprocess development and pharmacokinetic studies: Improving assay performance
Osterlund, K et al. Merck Technology Symposium. 2007  
Use of Gyrolab in Biotechnology Process Development
Bishop, E . Gyrolab Seminar. 2008  
Gyrolab applications in industrial monoclonal antibody development
Wallby, E et al. Poster. 2009  
Quantification of MabSelect SuRe ligand in presence of excess amounts of IgG on Gyrolab
Lehtonen, P & Inganas, M. Poster. 2009  
Development of residual host cell protein assays for recombinant microbial biopharmaceuticals
Peiris, KJ et al. 5th Annual European Gyrolab Seminar, Siena, Italy. 2011  
The Manufacture of mAbs - A Comparison of Performance and Process Time between Traditional and Ready-to-Use Disposable Systems
Eibl, R et al. Single-Use Technology in Biopharmaceutical Manufacture, Published Online: 19 Jan 2011 DOI: 10.1002/9780470909997.ch28. 2011  
A microfluidic approach to high throughput quantification of host cell protein impurities for bioprocess development
Heo, JH et al. Pharmaceutical Bioprocessing Vol. 2, No. 2, Pages 129-139. 2014  
Domain antibody downstream process optimization: High-throughput strategy and analytical methods
Welsh, J P et al. Engineering in Life Sciences, DOI: 10.1002/elsc.201400255. 2015  
Development of an acidic/neutral antibody flow-through polishing step using salt-tolerant anion exchange chromatography
Kang, Y et al. Pharm. Bioprocess. (2015) 3(8), 477-487. 2015  
Application Report 206: Single-system solution for quantification of monoclonal IgG and host cell proteins (HCP)
Inganäs, M. Gyros Application Report. 2011  
Application of the Gyrolab platform to ligand-binding assays: a user's perspective
Mora, J et al. Bioanalysis 2010, 2 (10) 1711-1715. 2010  
Rapid Process Development Enabled by Automated, Single Use High Throughput Technologies
Ramsubramaniam, N. 2015 Annual Meeting of the Society for Industrial Microbiology & Biotechnology, Session 22: Fermentation/Cell Culture: Biologics: Delivering Innovation to Industry and Patients Alike. 2015  
Parallel nanoliter microfluidic analysis system
Andersson, P et al. Anal Chem. 2007, 79 (11) 4022-4030. 2007  
Addressing Ligand Binding Assay Deficiencies
Brady, K. Genetic Engineering & biotechnology News 2009, 29 (14) 33. 2010  
Parallel sample preparation of proteins, from crude samples to crystals ready for MALDI-MS, in an integrated microfluidic system
Thuy, TT et al. J Chromatogr B Analyt Technol Biomed Life Sci, 2010 Oct 15;878(28):2803-10. 2010  
High-throughput profiling of N-linked oligosaccharides in therapeutic antibodies using a microfluidic CD platform and MALDI-MS
Thuy, TT et al. Anal Bioanal Chem (2011) 399:1601-1611. 2011  
Automated immunoassay equipment platforms for analytical support of pharmaceutical and biopharmaceutical development
Allinson, J L . Bioanalysis (2011) 3(24), 2803-2816. 2011  
Rapid affinity measurement of protein-protein interactions in a microfluidic platform.
Salimi-Moosavi, H et al. Anal Biochem. 2012 Jul 15;426(2):134-41. . 2012  
Discrimination between glycosylation patterns of therapeutic antibodies using a microfluidic platform, MALDI-MS and multivariate statistics
Thuy, TT et al. J Pharm Biomed Anal. 2012 Nov;70:47-52. 2012  
The Gyrolabâ„¢ immunoassay system: a platform for automated bioanalysis and rapid sample turnaround
Fraley, KJ et al. Bioanalysis 2013 Jul;5(14):1765-74. 2013  
Engineering a Monomeric Fc Domain Modality by N-Glycosylation for the Half-life Extension of Biotherapeutics
Ishino, T et al. J. Biol. Chem., Jun 2013; 288: 16529 - 16537. 2013  
Glycosylation Profiling of Therapeutic Antibodies in Serum Samples Using a Microfluidic CD Platform and MALDI-MS
Thuy, TT et al. J. Am. Soc. Mass Spectrom (2013). 2013  
Bioanalytical platform comparison using a generic human IgG PK assay format
Leary, BA et al. J Immunol Methods. 2013 Aug 29. pii: S0022-1759(13)00234-2. 2013  
Active glucagon-like peptide 1 quantitation in human plasma: A comparison of multiple ligand binding assay platforms
Fraser, S, et al. Journal of Immunological Methods, April 8. 2014  
Application of quality by design and statistical quality control concepts in immunoassays
Verch, T . Bioanalysis (2014) 6(23), 3251-3260. 2014  
Two cross-reactive monoclonal antibodies recognize overlapping epitopes on Neisseria meningitidis factor H binding protein but have different functional properties
Faleri, A et al. The FASEB Journal Vol. 28 April 2014 1644-1653. 2014  
Assessing Effects of Freeze-Thaw on Biotinylated Macromolecules Using Gyrolabâ„¢
Liu, XF et al. J Bioanal Biomed 6: 049-051. 2014  
Developability of Biotherapeutics
Hartmann, S et al. 2015  
16th Annual Land O'Lakes Bioanalytical Conference - Conference Report
Burns, EC et al. Bioanalysis Vol. 7, No. 21, Pages 2731-2734. 2015  
High-throughput screening and automation approaches for the development of recombinant therapeutic proteins
Keil, G. Pharm. Bioprocess. (2015) 3(5), 371-380. 2015  
Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety
Ryan, P C et al. Toxicology and Applied Pharmacology 279 (2014) 230–239. 2015  
The 3rd China Bioanalysis Forum annual meeting
Tang, D et al. Bioanalysis (Epub ahead of print). 2015  
7 Best Practices in Assessment of Developability of Biopharmaceutical Candidates
Hartmann, S et al. Developability of Biotherapeutics: Computational . 2015  
N-Glycan profile analysis of transferrin using a microfluidic compact disc and MALDI-MS
Quaranta, A et al. Analytical and Bioanalytical Chemistry (2016) 408:4765-4776. 2016  
A PCSK9-binding antibody that structurally mimics the EGF(A) domain of LDL-receptor reduces LDL cholesterol in vivo
Ni, YG et al. J Lipid Res 2011, 52(1) 78-86. 2011  
Automating bioanalytical sample analysis through enhanced system integration
Patel, V et al. Bioanalysis 2013 Jul;5(13):1649-59. 2013  
Unraveling the pharmacokinetic interaction of ticagrelor and MEDI2452 (Ticagrelor antidote) by mathematical modeling
Almquist, J et al. CPT Pharmacometrics Systems Pharmacology 2016 Jun;5(6):313-23 . 2016  
Two cross-reactive monoclonal antibodies recognize overlapping epitopes on Neisseria meningitidis factor H binding protein but have different functional properties.
Faleri, A, et al. Journal of Immunological Methods, April 8. 2014  
Gyrolab Demonstrated Shorter Assay Time and Broader Dynamic Range Compared to a Plate Based ELISA with a Generic Human IgG Assay in Rat Serum
Mallozzi, C & Kavosi, M. Inaugural North American Gyrolab Seminar. 2010  
High Throughput Ligand Binding Assay for Therapeutic Antibodies and Biomarkers Using Gyros Microfluidic Instrument
Salimi-Moosavi, H. NBC Symposium: Advantages of Non-Traditional Technologies for Ligand Binding Assay Development, 2010. 2010  
New analytical technologies for biological discovery
Shen, H-W & Yu, A-M. Bioanalysis 2010, 2(2), 181-184. 2010  
Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis
Roman, J et al. J Pharmacological Toxicological Methods, online December 2010. 2010  
Phase I, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of NI-0401 (a Fully Human Anti-CD3 Monoclonal Antibody) in Patients with Moderate to Severe Active Crohn̥s Disease
van der Woude, C et al. Inflamm Bowel Dis. 2010, 16(10) 1708-16. 2010  
A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma
Singh, D et al. BMC Pulm Med. 2010, 8 10:3. 2010  
An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males
Oh, C K et al. Brit J Pharmacol 2010, 69 (6) 645-655. 2010  
Impact of methionine oxidation in human IgG1 Fc on serum half-life of monoclonal antibodies
Wang, W et al. Mol Immunol 2011, 48 860-866, doi:10.1016/j.molimm.2010.12.009. 2011  
Implementation of a universal analytical method in early-stage development of human antibody therapeutics: application to pharmacokinetic assessment for candidate selection
Shih, J et al. Bioanalysis 2012, 4(19) 2357-2365. 2012  
Validation of a Gyrolab assay for quantification of rituximab in human serum
Liu, XF et al. J Pharmacol Toxicol Methods, 2012, 65 (3) 107-114. 2012  
A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study
Park, W et al. Ann Rheum Dis 2013;0:1-8. 2013  
Rapid development of multiple 'fit-for-purpose' assays on an automatic microfluidic system using a streamlined process in support of early biotherapeutics discovery programs
Liu, R et al. Bioanalysis 2013 Jul;5(14):1751-63. 2013  
An extended range generic immunoassay for total human therapeutic antibodies in preclinical pharmacokinetic studies
Hall, CM et al. J Immunol Methods. 2013 Jul 31;393(1-2):70-3. 2013  
Identification and Multidimensional Optimization of an Asymmetric Bispecific IgG Antibody Mimicking the Function of Factor VIII Cofactor Activity
Sampei, Z et al. PLoS ONE 8(2): e57479. 2013  
Analytical assay platforms for soluble target engagement biomarkers: old favorites and emerging technologies
Goodman, J et al. Bioanalysis (2013) 5(23), 2919-2931. 2013  
Sustained peripheral depletion of amyloid-β with a novel form of neprilysin does not affect central levels of amyloid-β
Henderson, SJ et al. Brain (2013) doi: 10.1093/brain/awt308 . 2013  
Capillary microsampling and analysis of 4-μl blood, plasma and serum samples to determine human a-synuclein elimination rate in mice
Jonsson, O et al. Bioanalysis 2013, 5(5) 449-462. 2013  
One Mouse, One Pharmacokinetic Profile: Quantitative Whole Blood Serial Sampling for Biotherapeutics
Joyce, AP, et al. Pharm Res. 2014 Jan 24. 2014  
A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays
Zoghbi, J. J Immunol Methods. 2015 Nov;426:62-9. 2014  
A Multifactorial Screening Strategy to Identify Anti-Idiotypic Reagents for Bioanalytical Support of Antibody Therapeutics
Salimi-Moosavi, H et al. Analytical Biochemistry S0003-2697(14)00452-7. 2014  
Validation of a microfluidic platform to measure total therapeutic antibodies and incurred sample reanalysis performance
Magana, I et al. Bioanalysis (2014) 6(19), 2623-2633. 2014  
Abstract 4293: Whole-body bio-distribution of anti-5T4-mcMMAF (anti-5T4-ADC) using fluorescence molecular tomography (FMT) imaging in a non-small cell lung cancer mice model.
Giddabasappa, A et al. Cancer Res October 1, 74; 4293. 2014  
Etanercept ameliorates inflammation and pain in a novel mono-arthritic multi-flare model of streptococcal cell wall induced arthritis
Chakravarthy, K et al. BMC Musculoskeletal Disorders 2014, 15:409. 2014  
Challenges in selectivity, specificity and quantitation range of ligand-binding assays: case studies using a microfluidics platform
Yang, T-Y et al. Bioanalysis (2014) 6(8), 1049-1057. 2014  
Serum sample stability in ligand-binding assays: challenges in assessments of long-term, bench-top and multiple freeze-thaw
Cris Macaraeg et al. Bioanalysis (2015) 7(11), 1361-1370. 2015  
Miniaturized Blood Sampling Techniques to Benefit Reduction in Mice and Refinement in Nonhuman Primates: Applications to Bioanalysis in Toxicity Studies with Antibody-Drug Conjugates
Caron, A et al. Journal of the American Association for Laboratory Animal Science, Vol 54, No 2 March 2015 Pages 145-152. 2015  
Indirect assessment of neutralizing anti-drug antibodies utilizing pharmacokinetic assay data
Vettermann, C et al. Journal of Immunological Methods S0022-1759(15)30076-4. 2015  
Studies of Nontarget-Mediated Distribution of Human Full-Length IgG1 Antibody and Its FAb Fragment in Cardiovascular and Metabolic-Related Tissues
Davidsson, P et al. Journal of Pharmaceutical Sciences, Vol. 104, Volume 104, Issue 5, pages 1825-1831, May 2015 . 2015  
Emerging Technologies to Increase Ligand Binding Assay Sensitivity
Fischer, SK et al. The AAPS Journal, Vol. 17, No. 1 . 2015  
Platform switching from ELISA to Gyrolab™: a novel generic reagent omits the need to change critical reagents
Jordan, G et al. Bioanalysis 2016 Apr;8(8):807-14 . 2016  
Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies
Avery, LB et al. mAbs 2016 May 27:1-15. [Epub ahead of print]. 2016  
Deciphering the In Vivo Performance of a Monoclonal Antibody to Neutralize Its Soluble Target at the Site of Action in a Mouse Collagen-Induced Arthritis Model
Weirong, W et al. Pharmaceutical Research, 2016, 1-10 . 2016  
Quantitative analysis of hIgG1 in monkey serum by LC-MS/MS using mass spectrometric immunoassay
Lanshoeft, C et al. Bioanalysis 2016 May;8(10):1035-49. 2016  
Accelerating Regulated Bioanalysis for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform
Liu, R et al. The AAPS Journal, Volume 19, Issue 1, pp 82-91. 2016  
Discovery of Novel Blood-Brain Barrier Targets to Enhance Brain Uptake of Therapeutic Antibodies
Zuchero, YJ, et al. Neuron 89, 70-82. 2016  
Feasibility of Singlet Analysis for Ligand Binding Assays: a Retrospective Examination of Data Generated Using the Gyrolab Platform
Clark, TH. AAPS J. 2016 Sep;18(5):1300-8. 2016  
Reagent-free LC-MS/MS-based pharmacokinetic quantification of polyhistidine-tagged therapeutic proteins
Shi, J et al. Bioanalysis. 2017 Feb;9(3):251-264. 2017  
Long-acting protein drugs for the treatment of ocular diseases
Ghost, GJ, et al. Nature communications 2017 Mar 23;8:14837. 2017  
Gyrolab in a GxP environment: the Merck Serono experience
Crosasso, C et al. Poster. 2010  
Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective
Coleman, D et al. Bioanalysis. 2017 May 19. doi: 10.4155/bio-2017-0032. [Epub ahead of print]. 2017  
Bioanalytical approaches for characterizing catabolism of antibody-drug conjugates
Saad, OM et al. Bioanalysis (2015) 7(13). 2015  
A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma
Piper, E et al. Eur Respir J. 2013 February; 41(2): 330-338. 2013  
Production of Non-fucosylated Antibodies by Co-Expression of Heterologous GDP-6-deoxy-D-lyxo-4-hexulose reductase
von Horsten, H. Glycobiology. 2010, 20 (12) 1607-18. 2010  
Evaluation of a Single-Use Bioreactor for the Fed-Batch Production of a Monoclonal Antibody
Cameau, E et al. BioPharm International Supplements, Nov. 2010. 2010  
A semi-universal assay platform to quantitate vaccines with potential applications for biotherapeutics
Roman, J et al. Bioanalysis (2016) 8(24), 2523-2535. 2016  
Evaluation of a digital dispenser for direct curve dilutions in a vaccine potency Assay
Roselle, C et al. Journal of Immunological Methods. 2017  
Application Report 205: Quantification of antigen-specific antibodies in serum
Inganäs, M. Gyros Application Report. 2011  
Gyrolab in a validated environment
Kelley, M. Gyrolab Seminar, 2009. 2009  
An integrated precipitation and ion-exchange chromatography process for antibody manufacturing: Process development strategy and continuous chromatography exploration
Großhans, S. et al. Journal of Chromatography A Available online 6 December 2017. 2017  
Optimizing NBE PK/PD assays using the Gyrolab Affinity Software; conveniently within the bioanalyst's existing workflow
Myzithras, M. et al. Bioanalysis. 2018 Mar 1;10(6):397-406. 2018  
Human protective response induced by meningococcus B vaccine is mediated by the synergy of multiple bactericidal epitopes
Giuliani, M. et al. Nature, Scientific Reports Volume 8, Article number: 3700. 2018  
Evaluation of recent Protein A stationary phase innovations for capture of biotherapeutics
Pabst, T.M. et al. J Chromatogr A. 2018 Jun 15;1554:45-60. 2018  
High-Throughput Methods Evaluation: Impurities Determination During Upstream and Downstream In-Process Development
Zimmermann, E. et al. Article on 2016  
A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study
Yoo, DH. et al Annals of the Rheumatic Diseases 2013 Oct;72(10):1613-20. 2013  
Singlicate analysis: should this be the default for biomarker measurements using ligand-binding assays?
Ye, Z. et al. Bioanalysis, Vol. 10, No. 12. 2018  
Adnectin–drug conjugates for Glypican-3-specific delivery of a cytotoxic payload to tumors
Lipovšek, D. et al. Protein Engineering, Design and Selection, gzy013. 2018  
Monoclonal antibody targeting of fibroblast growth factor receptor 1c causes cardiac valvulopathy in rats
Buss, N. et al. Toxicology and Applied Pharmacology, Available online 2 July 2018. 2018  
Assessment of near-infrared fluorophores to study the biodistribution and tumor targeting of an IL13 receptor α2 antibody by fluorescence molecular tomography
Gupta, P. et al. Oncotarget, 2017, Vol. 8, (No. 34), pp: 57231-57245 2017  
Quantitative analysis of four protein biomarkers: An automated microfluidic cartridge-based method and its comparison to colorimetric ELISA
Dysinger, M. J Immunol Methods. 2017 Dec;451:1-10.  2017  
A Multi-site In-depth Evaluation of the Quanterix Simoa from a User’s Perspective
Chunyk, AG. et al. AAPS J. 2017 Dec 1;20(1):10. 2017  
Development and characterisation of a novel glucagon like peptide-1 receptor antibody
Biggs, EK. et al. Diabetologia. 2017 Nov 9. 2017  
CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial
Stebbing, J. et al. Lancet Oncol. 2017 Jul;18(7):917-928. 2017  
Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial
Gulley, JG. et al. Lancet Oncol. 2017 May;18(5):599-610. 2017  
Human circulating influenza-CD4+ ICOS1+IL-21+ T cells expand after vaccination, exert helper function, and predict antibody responses
Spensieria, F. et al. Proceedings of the National Academy of Sciences of the United States 2013 Aug 27;110(35):14330-5. 2013  
A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study
Yoo, DH, et al. Arthritis Research & Therapy (2016) 18:82 2016  
One-step integrated clarification and purification of a monoclonal antibody using Protein A Mag Sepharose beads and a cGMP-compliant high-gradient magnetic separator
Ebeler, M, New Biotechnology Volume 42, 25 May 2018, Pages 48-55 2018  
Affinity determination of biomolecules: a kinetic model for the analysis of pre?equilibrium titration curves
Vanhove, E. European Biophysics Journal 2018  
An integrated precipitation and ion-exchange chromatographyprocess for antibody manufacturing: Process development strategyand continuous chromatography exploration
Großhans, s. et al. J Chromatogr A. 2018 Jan 19;1533:66-76.  2018  
Emerging technologies for biotherapeutic bioanalysis from a high-throughput and multiplexing perspective: insights from an AAPS emerging technology action program committee
Purushothama, S, et al. Bioanalysis. 2018 Feb;10(3):181-194 2018  
Evaluation of the pharmacokinetic equivalence and 54-week effi cacy and safety of CT-P13 and innovator infl iximab in Japanese patients with rheumatoid arthritis
Takeuchi, T, et al. Modern Rheumatology, 2015; 25(6): 817–824 2015  
Optimization of an Enzymatic Antibody?Drug Conjugation Approach Based on Coenzyme A Analogs
Grünewald, J. et al. Bioconjugate Chemistry 2017 Jul 19;28(7):1906-1915 2017  
Overcoming disease-specific matrix effect in a clinical pharmacokinetic assay using a microfluidic immunoassay technology
Williams, K, et al. Bioanalysis. 2017 Aug;9(16):1207-1216 2017  
Pharmacokinetic and Pharmacodynamic Profiles of Glyco-Modified Atrial Natriuretic Peptide Derivatives Synthesized Using Chemo-enzymatic Synthesis Approaches
Iwamoto, M, et al. Bioconjugate Chem. 2018, 29, 2829?2837 2018  
Pharmacokinetics of an intracerebroventricularly administered antibody in rats
Noguchi, Y, et al. MAbs. 2017 Oct;9(7):1210-1215 2017  
Recent developments and advances of FGFR as a potential target in cancer
Xue, WJ, et al. Future Medicinal Chemistry  2018  
Singlicate Ligand Binding Assay Using an Automated Microfluidic System: a Clinical Case Study
Jiang, H, et al. The AAPS Journal Sep;19(5):1461-1468 2017  
Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate
Matsuno, H, et al. Ann Rheum Dis. 2018 Apr; 77(4): 488–494.  2018  
Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study
Yoo, DH, et al. Ann Rheum Dis: first published as 10.1136/annrheumdis-2015-208786 on 29 April 2016. 2016  
EBF recommendation on practical management of critical reagents for PK ligand binding assays
Phil, S, et al. Bioanalysis, 2018 2018  
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Rapid Production of Human VEGF-A following Intradermal Injection of Modified VEGF-A mRNA Demonstrated by Cutaneous Microdialysis in the Rabbit and Pig In Vivo
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Targeting CLDN18.2 by CD3 Bispecific and ADC Modalities for the Treatments of Gastric and Pancreatic Cancer
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Host-Cell Protein Analysis to Support Downstream Process Development: A High-Throughput Platform with Automated Sample Preparation
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Comprehensive Profiling of the Rheumatoid Arthritis Antibody Repertoire
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A capillary electrophoresis based approach for the identi?cation of anti-drug antibodies against camelid VHH biologics (Nanobodies®)
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Inhibition of complement pathway activation with Pozelimab, a fully human antibody to complement component C5
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Cocrystal structure of meningococcal factor H binding protein variant 3 reveals a new crossprotective epitope recognized by human mAb 1E6
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FS222, a CD137/PD-L1 tetravalent bispecific antibody exhibits low toxicity and anti-tumor activity in colorectal cancer models
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Use of translational modeling and simulation for quantitative comparison of PF-06804103, a new generation HER2 ADC, with Trastuzumab-DM-1
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Integration of Acoustic Liquid Handling into Quantitative Analysis of Biological Matrix Samples
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Analytical methods for process and product characterization of recombinant adeno-associated virus-based gene therapies
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Pharmacokinetic-Pharmacodynamic Modelling of Systemic IL13 Blockade by Monoclonal Antibody Therapy: A Free Assay Disguised as Total
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Preclinical characterization of the ADME properties of a surrogate anti IL 36R monoclonal antibody antagonist in mouse serum and tissues
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Comparing singlet and duplicate immunogenicity assay in human plasma for pembrolizumab using Gyrolab®
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Development of an Antibody-Like T-cell Engager based on VH-VL heterodimer formation and its application in cancer therapy
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Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling
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Blocking endothelial lipase with monoclonal antibody MEDI5884 durably increases high density lipoprotein in nonhuman primates and in a phase 1 trial
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Development of an activated carbon filtration step and high throughput screening method to remove host cell proteins from a recombinant enzyme process
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Assessment of low volume sampling technologies: utility in nonclinical and clinical studies
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Comparable Pharmacokinetics, Safety, and Tolerability of Etrolizumab Administered by Prefilled Syringe or Autoinjector in a Randomized Trial in Healthy Volunteers
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Comparison of Bevacizumab Quantification Results in Plasma of Non-small Cell Lung Cancer Patients using Bioanalytical techniques between LC-MS, ELISA and Microfluidic-based immunoassay
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Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling
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Critical reagent characterization and re-evaluation to ensure long-term stability: two case studies
Caiazzo et al. Bioanalysis 2021  
Blocking endothelial lipase with monoclonal antibody MEDI5884 durably increases high density lipoprotein in nonhuman primates and in a phase 1 trial
Le Lay et al.  Science translational medicine 2021  
Critical reagent generation, characterization, handling and storage workflows: impact on LBA assays
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Development of an activated carbon filtration step and high throughput screening method to remove host cell proteins from a recombinant enzyme process
Slocum et al. Biotechnology progress 2021  
Assessment of low volume sampling technologies: utility in nonclinical and clinical studies
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Comparable Pharmacokinetics, Safety, and Tolerability of Etrolizumab Administered by Prefilled Syringe or Autoinjector in a Randomized Trial in Healthy Volunteers
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Comparison of Bevacizumab Quantification Results in Plasma of Non-small Cell Lung Cancer Patients using Bioanalytical techniques between LC-MS, ELISA and Microfluidic-based immunoassay
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Novel techniques and the new age of biomarkers: panel discussion report
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The role of ligand-binding assay and LC–MS in the bioanalysis of complex protein and oligonucleotide therapeutics
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Antibody avidity, persistence, and response to antigen recall:comparison of vaccine adjuvants
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