Publications

NIBSC scientists produce a number of publications each year. Below we provide a complete list of our scientific publications between 2014-2020.

Publications by year
2023
2022
2021
2019
2018
2017
2016
2015 
2014

2023

Foley JH, Shehu E, Riddell A, Gray E, Goodale A, Yu IM, Verhoef D, Little J, Shattock D, Kitchen S, Chowdary P, Corbau R, Nathwani AC. Differences in wild-type- and R338L-tenase complex formation are at the root of R338L-factor IX assay discrepancies: Blood Adv. 2023 Feb 14;7(3):458-467. doi: 10.1182/bloodadvances.2022007435.35839077  Parafioriti M, Ni M, Petitou M, Mycroft-West CJ, Rudd TR, Gandhi NS, Ferro V, Turnbull JE, Lima MA, Skidmore MA, Fernig DG, Yates EA, Bisio A, Guerrini M, Elli S. Evidence for Multiple Binding Modes in the Initial Contact Between SARS-CoV-2 Spike S1 Protein and Cell Surface Glycans: Chemistry. 2023 Jan 2;29(1):e202202599. doi: 10.1002/chem.202202599. Epub 2022 Nov 7.36134621  Lilley E, Coppens E, Das P, Galaway F, Isbrucker R, Sheridan S, Stickings P, Holmes A. Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of vaccines and biological therapeutics manufacturers: Biologicals. 2023 Feb;81:101660. doi: 10.1016/j.biologicals.2022.11.002. Epub 2022 Nov 12.36376163 Delfin-Riela T, Rossotti MA, Mattiuzzo G, Echaides C, González-Sapienza G. Nanobody-Based Blocking of Binding ELISA for the Detection of Anti-NS1 Zika-Virus-Specific Antibodies in Convalescent Patients: Trop Med Infect Dis. 2023 Jan 10;8(1):55. doi: 10.3390/tropicalmed8010055.36668962 Grassly NC, Andrews N, Cooper G, Stephens L, Waight P, Jones CE, Heath PT, Calvert A, Southern J, Martin J, Miller E. Effect of maternal immunisation with multivalent vaccines containing inactivated poliovirus vaccine (IPV) on infant IPV immune response: A phase 4, multi-centre randomised trial: Vaccine. 2023 Feb 10;41(7):1299-1302. doi: 10.1016/j.vaccine.2023.01.035. Epub 2023 Jan 21.36690561 Kang HN, Wadhwa M, Knezevic I, Ondari C, Simao M. WHO guidelines on biosimilars: Toward improved access to safe and effective products: Ann N Y Acad Sci. 2023 Mar;1521(1):96-103. doi: 10.1111/nyas.14965. Epub 2023 Jan 24.36694455 Kingston NJ, Grehan K, Snowden JS, Hassall M, Alzahrani J, Paesen GC, Sherry L, Hayward C, Roe A, Stephen S, Tomlinson D, Zeltina A, Doores KJ, Ranson NA, Stacey M, Page M, Rose NJ, Bowden TA, Rowlands DJ, Stonehouse NJ. VelcroVax: a "Bolt-On" Vaccine Platform for Glycoprotein Display: mSphere. 2023 Feb 21;8(1):e0056822. doi: 10.1128/msphere.00568-22. Epub 2023 Jan 31.36719225 Hogwood J, Mulloy B, Lever R, Gray E, Page CP. Pharmacology of Heparin and Related Drugs: An Update: Pharmacol Rev. 2023 Mar;75(2):328-379. doi: 10.1124/pharmrev.122.000684. Epub 2023 Feb 15.36792365 Jennings I, Lester W, Gray E, Reilly-Stitt C, Gomez K, Williams S, Kitchen S, Walker I. Effect of direct thrombin inhibitors on laboratory measurement of fibrinogen: Potential for errors in clinical decision-making: Int J Lab Hematol. 2023 Feb 15. doi: 10.1111/ijlh.14040. Online ahead of print.36793181 Corogeanu D, Zaki K, Beavil AJ, Arnold JN, Diebold SS. Antibody conjugates for targeted delivery of Toll-like receptor 9 agonist to the tumor tissue: PLoS One. 2023 Mar 13;18(3):e0282831. doi: 10.1371/journal.pone.0282831. eCollection 2023.36913398 Akello JO, Bujaki E, Shaw AG, Khurshid A, Arshad Y, Troman C, Majumdar M, O’Toole Á, Rambaut A, Alam MM, Martin J, Grassly NC. Comparison of Eleven RNA Extraction Methods for Poliovirus Direct Molecular Detection in Stool Samples: Microbiol Spectr. 2023 Mar 20:e0425222. doi: 10.1128/spectrum.04252-22. Online ahead of print.36939356 Bermingham WH, Canning B, Wilton T, Kidd M, Klapsa D, Majumdar M, Sooriyakumar K, Martin J, Huissoon AP. Case report: Clearance of longstanding, immune-deficiency-associated, vaccine-derived polio virus infection following remdesivir therapy for chronic SARS-CoV-2 infection: Front Immunol. 2023 Mar 3;14:1135834. doi: 10.3389/fimmu.2023.1135834. eCollection 2023.36936936 McCarthy D, Han Y, Carrick K, Schmidt D, Workman W, Matejtschuk P, Duru C, Atouf F. Reference Standards to Support Quality of Synthetic Peptide Therapeutics: Pharm Res. 2023 Mar 22. doi: 10.1007/s11095-023-03493-1. Online ahead of print.36949371 Burns K, Dorfmueller HC, Wren BW, Mawas F, Shaw HA. Progress towards a glycoconjugate vaccine against Group A Streptococcus: NPJ Vaccines. 2023 Mar 28;8(1):48. doi: 10.1038/s41541-023-00639-5.36977677 Coombes NS, Bewley KR, Le Duff Y, Hurley M, Smith LJ, Weldon TM, Osman K, Pullan S, Berry N, Hallis B, Charlton S, Hall Y, Funnell SGP. Assessment of the Biological Impact of SARS-CoV-2 Genetic Variation Using an Authentic Virus Neutralisation Assay with Convalescent Plasma, Vaccinee Sera, and Standard Reagents: Viruses. 2023 Feb 25;15(3):633. doi: 10.3390/v15030633.36992342 Ho MM, Dagg B, Govind S, Hockley J; Collaborative Study Group. The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques: Biologicals. 2023 May;82:101667. doi: 10.1016/j.biologicals.2023.101667. Epub 2023 Mar 31.37004276 Hoefnagel MHN, Stickings P, Smith D, Jungbäck C, Van Molle W, Tesolin L. Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over in vivo release testing of vaccines: Expert Rev Vaccines. 2023 Jan-Dec;22(1):369-377. doi: 10.1080/14760584.2023.2198601.37010241 Hogwood J, Gray E, Mulloy B. Heparin, Heparan Sulphate and Sepsis: Potential New Options for Treatment: Pharmaceuticals (Basel). 2023 Feb 10;16(2):271. doi: 10.3390/ph16020271.37259415 Althaus T, Landier J, Zhu F, Raps H, Dejoux O, Costantini A, Lavagna C, Rampal P, Mattiuzzo G, Xu S, Wang LF, Voiglio EJ. The Impact of Severe Acute Respiratory Syndrome Coronavirus 2 Vaccination and Infection on Neutralizing Antibodies: A Nation-wide Cross-sectional Analysis: J Infect Dis. 2023 May 29;227(11):1255-1265. doi: 10.1093/infdis/jiad030.36780397 Hardy LJ, Bohinc D, Bane KL, Heal SL, Hethershaw E, Ali M, Palmer-Dench T, Foster R, Longstaff C, Renné T, Stavrou EX, Philippou H. Glycated albumin modulates the contact system with implications for the kallikrein-kinin and intrinsic coagulation systems: J Thromb Haemost. 2023 Apr;21(4):814-827. doi: 10.1016/j.jtha.2022.12.015. Epub 2022 Dec 27.36990522 Oftedal BE, Delaleu N, Dolan D, Meager A, Husebye ES, Wolff ASB. Systemic interferon type I and B cell responses are impaired in autoimmune polyendocrine syndrome type 1: FEBS Lett. 2023 May;597(9):1261-1274. doi: 10.1002/1873-3468.14625. Epub 2023 Apr 20.37052889 Dutan Polit L, Eidhof I, McNeill R, Warre-Cornish K, Yde Ohki CM, Monet Walter N, Sala C, Verpelli C, Radtke F, Galderisi S, Mucci A, Collo G, Edenhofer F, Castrén ML, Réthelyi JM, Ejlersen M, Simone Hohmann S, Ilieva MS, Lukjanska R, Matuleviciute R, Srivastava DP Recommendations, guidelines, and best practice for the use of human induced pluripotent stem cells for neuropharmacological studies of neuropsychiatric disorders: Neuroscience Applied. 2023 Apr 21; 2:101125. doi.org/10.1016/j.nsa.2023.101125. Vermeulen M, Feck I, Francotte A, Hassall L, Tesolin L, Van Molle W, Pizzato R, Laurent T, Hoebreck C, Stickings P, Dobly A. Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines: J Immunol Methods. 2023 Jun;517:113483. doi: 10.1016/j.jim.2023.113483. Epub 2023 Apr 24.37100343 Waldock J, Remarque EJ, Zheng L, Ho S, Hoschler K, Neumann B, Sediri-Schön H, Trombetta CM, Montomoli E, Marchi S, Lapini G, Zhou F, Lartey SL, Cox RJ, Facchini M, Castrucci MR, Friel D, Ollinger T, Caillet C, Music N, Palladino G, Engelhardt OG; FLUCOP consortium. Haemagglutination inhibition and virus microneutralisation serology assays: use of harmonised protocols and biological standards in seasonal influenza serology testing and their impact on inter-laboratory variation and assay correlation: A FLUCOP collaborative study: Front Immunol. 2023 Apr 18;14:1155552. doi: 10.3389/fimmu.2023.1155552. eCollection 2023.37143658 Hassall L, Rigsby P, Stickings P. Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine: Biologicals. 2023 May;82:101682. doi: 10.1016/j.biologicals.2023.101682. Epub 2023 May 5.37149975 Childers KC, Avery NG, Estrada Alamo KA, Davulcu O, Haynes RM, Lollar P, Doering CB, Coxon CH, Spiegel PC. Structure of coagulation factor VIII bound to a patient-derived anti-C1 domain antibody inhibitor: Blood. 2023 May 16:blood.2023020181. doi: 10.1182/blood.2023020181. Online ahead of print.37192299 Yang J, Jiao J, Draheim KM, Yang G, Yang H, Yao LC, Shultz LD, Greiner DL, Rajagopal D, Vessillier S, Maier CC, Mohanan S, Cai D, Cheng M, Brehm MA, Keck JG. Simultaneous evaluation of treatment efficacy and toxicity for bispecific T-cell engager therapeutics in a humanized mouse model: FASEB J. 2023 Jun;37(6):e22995. doi: 10.1096/fj.202300040R.37219526 Merrick B, Sergaki C, Edwards L, Moyes DL, Kertanegara M, Prossomariti D, Shawcross DL, Goldenberg SD. Modulation of the Gut Microbiota to Control Antimicrobial Resistance (AMR)-A Narrative Review with a Focus on Faecal Microbiota Transplantation (FMT): Infect Dis Rep. 2023 May 9;15(3):238-254. doi: 10.3390/idr15030025.37218816 Keeley AJ, Groves D, Armitage EP, Senghore E, Jagne YJ, Sallah HJ, Drammeh S, Angyal A, Hornsby H, de Crombrugghe G, Smeesters P, Rossi O, Carducci M, Peno C, Bogaert D, Kampmann B, Marks M, Shaw HA, Turner CE, de Silva TI; MRCG Strep A Study Group. Streptococcus pyogenes colonization in children aged 24-59 months in The Gambia: Impact of Live Attenuated Influenza Vaccine and associated serological responses: J Infect Dis. 2023 May 29:jiad153. doi: 10.1093/infdis/jiad153. Online ahead of print.37246259 Sharma D, Zachary I, Jia H. Mechanisms of Acquired Resistance to Anti-VEGF Therapy for Neovascular Eye Diseases: Invest Ophthalmol Vis Sci. 2023 May 1;64(5):28. doi: 10.1167/iovs.64.5.28.37252731 Raut S, Daas A, Rigsby P, Costanzo A. Assay discrepancies using human coagulation factor VIII chromogenic kits: Results from a plasma-derived factor VIII collaborative study (BSP112): Pharmeur Bio Sci Notes. 2023;2023:1-14.37272308 Singanayagam A, Klapsa D, Burton-Fanning S, Hand J, Wilton T, Stephens L, Mate R, Shillitoe B, Celma C, Slatter M, Flood T, Gopal R, Martin J, Zambon M. Asymptomatic immunodeficiency-associated vaccine-derived poliovirus infections in two UK children: Nat Commun. 2023 Jun 9;14(1):3413. doi: 10.1038/s41467-023-39094-0.37296153 Toon K, Kalemera MD, Palor M, Rose NJ, Takeuchi Y, Grove J, Mattiuzzo G. GB Virus B and Hepatitis C Virus, Distantly Related Hepaciviruses, Share an Entry Factor, Claudin-1: J Virol. 2023 Jun 13:e0046923. doi: 10.1128/jvi.00469-23. Online ahead of print.37310242 Alessi MC, Coxon C, Ibrahim-Kosta M, Bacci M, Voisin S, Rivera J, Greinacher A, Raster J, Pulcinelli F, Devreese KM, Mullier F, McCormick AN, Frontroth JP, Pouplard C, Sachs UJ, Diaz I, Bermejo N, Camera M, Fontana P, Bauters A, Stepanian A, Cozzi MR, Sveshnikova AN, Faille D, Hollon W, Chitlur M, Casonato A, Lasne D, Lavenu-Bombled C, Fiore M, Hamidou B, Hurtaud-Roux MF, Saultier P, Goumidi L, Gresele P, Lordkipanidzé M. Multi-center evaluation of light transmission platelet aggregation reagents: Communication from the ISTH SSC Subcommittee on Platelet Physiology: J Thromb Haemost. 2023 Jun 16:S1538-7836(23)00492-0. doi: 10.1016/j.jtha.2023.05.027. Online ahead of print.37331519 Ekimov A, Arunachalam AB, Blake T, Bodle J, Couzens L, Dubey S, Eichelberger M, Engelhardt OG, Gubinelli F, Joshi M, Melnyk D, Palladino G, Rigsby P, Rockman S, Savina N, Smith E, Gilchrist SAN; World Health Organization’s Pandemic Influenza preparedness, Vaccine Response’s Alternative Potency, Reagents Technical Working Group. Assessing the stability-indicating properties of alternative potency assays for inactivated influenza vaccine: Vaccine. 2023 Jun 19:S0264-410X(23)00726-0. doi: 10.1016/j.vaccine.2023.06.051. Online ahead of print.37344260 Rathod V, Kadam L, Gautam M, Gumma PD, Marke K, Asokanathan C, Douglas-Bardsley A, Hassell L, Bhandare S, Gupta S, Parekh S, Pujari P, Rao H, Sharma H, Shaligram U, Gairola S. Multiplexed bead-based assay for the simultaneous quantification of human serum IgG antibodies to tetanus, diphtheria, pertussis toxin, filamentous hemagglutinin, and pertactin: Front Immunol. 2023 Jun 5;14:1190404. doi: 10.3389/fimmu.2023.1190404. eCollection 2023.37342321 Govind S, Fritzsche M, Jenkins A, Cleveland MH, Vallone PM, Almond N, Morris C, Berry N. Deep Sequencing and Molecular Characterisation of BK Virus and JC Virus WHO International Reference Materials for Clinical Diagnostic Use: Viruses. 2023 May 30;15(6):1289. doi: 10.3390/v15061289.37376589 Avumegah MS, Mattiuzzo G, Särnefält A, Page M, Makar K, Lathey J, Kim J, Yimer SA, Craig D, Knezevic I, Bernasconi V, Kristiansen PA, Kromann I. Availability and use of Standards in vaccine development: NPJ Vaccines. 2023 Jun 30;8(1):95. doi: 10.1038/s41541-023-00692-0.37391580 Kingston NJ, Snowden JS, Martyna A, Shegdar M, Grehan K, Tedcastle A, Pegg E, Fox H, Macadam AJ, Martin J, Hogle JM, Rowlands DJ, Stonehouse NJ. Production of antigenically stable enterovirus A71 virus-like particles in Pichia pastoris as a vaccine candidate: J Gen Virol. 2023 Jun;104(6). doi: 10.1099/jgv.0.001867.37390009 Aguirre-Botero MC, Wang LT, Formaglio P, Aliprandini E, Thiberge JM, Schön A, Flores-Garcia Y, Mathis-Torres S, Flynn BJ, da Silva Pereira L, Le Duff Y, Hurley M, Nacer A, Bowyer PW, Zavala F, Idris AH, Francica JR, Seder RA, Amino R. Cytotoxicity of human antibodies targeting the circumsporozoite protein is amplified by 3D substrate and correlates with protection: Cell Rep. 2023 Jun 28;42(7):112681. doi: 10.1016/j.celrep.2023.112681. Online ahead of print.37389992 Manenti A, Solfanelli N, Cantaloni P, Mazzini L, Leonardi M, Benincasa L, Piccini G, Marchi S, Boncioli M, Spertilli Raffaelli C, Tacconi D, Mattiuzzo G, Kistner O, Montomoli E, Trombetta CM. Evaluation of Monkeypox- and Vaccinia virus-neutralizing antibodies in human serum samples after vaccination and natural infection: Front Public Health. 2023 Jun 21;11:1195674. doi: 10.3389/fpubh.2023.1195674. eCollection 2023.37415699 Yeh MT, Smith M, Carlyle S, Konopka-Anstadt JL, Burns CC, Konz J, Andino R, Macadam A. Genetic stabilization of attenuated oral vaccines against poliovirus types 1 and 3: Nature. 2023 Jul;619(7968):135-142. doi: 10.1038/s41586-023-06212-3. Epub 2023 Jun 14.37316671 Wolff ASB, Hansen L, Grytaas MA, Oftedal BE, Breivik L, Zhou F, Hufthammer KO, Sjøgren T, Olofsson JS, Trieu MC, Meager A, Jørgensen AP, Lima K, Greve-Isdahl Mohn K, Langeland N, Cox RJ, Husebye ES. Vaccination prevents severe COVID-19 outcome in patients with neutralizing type 1 interferon autoantibodies: iScience. 2023 Jul 21;26(7):107084. doi: 10.1016/j.isci.2023.107084. Epub 2023 Jun 9.37346050 Trakoolwilaiwan T, Takeuchi Y, Leung TS, Sebek M, Storozhuk L, Nguyen L, Tung LD, Thanh NTK. Development of a thermochromic lateral flow assay to improve sensitivity for dengue virus serotype 2 NS1 detection: Nanoscale. 2023 Aug 10;15(31):12915-12925. doi: 10.1039/d3nr01858j.37427537 Couto PS, Stibbs DJ, Rotondi MC, Takeuchi Y, Rafiq QA. Scalable manufacturing of gene-modified human mesenchymal stromal cells with microcarriers in spinner flasks: Appl Microbiol Biotechnol. 2023 Sep;107(18):5669-5685. doi: 10.1007/s00253-023-12634-w. Epub 2023 Jul 20.37470820 Viviani L, Balks E, Beken S, Brady AM, Clayton R, Cliquet F, Desmayanti L, Fragoeiro S, Hamtak TJ, John D, Jungbaëck C, Kalaivani M, Kross I, Lang C, Ria Isriyanthi NM, Mallet L, Milne C, Rubbrecht M, Siklódi B, Singh B, Srinivas GB, Stickings P, Stirling C, Sundram P, Szabó M, Thomas A, van den Berg M, Walker A, Philippe C, Vandeputte J. 3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report: Biologicals. 2023 Aug;83:101695. doi: 10.1016/j.biologicals.2023.101695. Epub 2023 Jul 27.37516084 van Walstijn C, Verweij S, Care R, Rigsby P, Clapper EB, Markey K, Vandebriel RJ, Stickings P, Hoefnagel MHN. Variability of in vivo potency assays of whole-cell pertussis, inactivated polio, and meningococcal B vaccines: Vaccine. 2023 Aug 31;41(38):5603-5613. doi: 10.1016/j.vaccine.2023.07.054. Epub 2023 Jul 30.37527955 Perry C, Mujahid N, Takeuchi Y, Rayat ACME. Insights into product and process related challenges of lentiviral vector bioprocessing: Biotechnol Bioeng. 2023 Aug 1. doi: 10.1002/bit.28498. Online ahead of print.37526313 Pan L, Mora J, Walravens K, Wagner L, Hopper S, Loo L, Bettoun D, Bond S, Dessy F, Downing S, Garofolo F, Gupta S, Henderson N, Irwin C, Ishii-Watabe A, Kar S, Jawa V, Joseph J, Malvaux L, Marshall JC, McDevitt J, Mohapatra S, Seitzer J, Smith J, Solstad T, Sugimoto H, Tounekti O, Wu B, Wu Y, Xu Y, Xu J, Yamamoto T, Yang L, Torri A, Kirshner S, Maxfield K, Vasconcelos JP, Abhari MR, Verthelyi D, Brodsky E, Carrasco-Triguero M, Kamerud J, Andisik M, Baltrukonis D, Bivi N, Cludts I, Coble K, Gorovits B, Gunn GR, Gupta S, Millner AH, Joyce A, Kubiak RJ, Kumar S, Liao K, Manangeeswaran M, Partridge M, Pine S, Poetzl J, Rajadhyaksha M, Rasamoelisolo M, Richards S, Song Y, Swanson S, Thacker S, Wadhwa M, Wolf A, Zhang L, Zhou L. 2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach): Bioanalysis. 2023 Jul;15(14):773-814. doi: 10.4155/bio-2023-0135. Epub 2023 Aug 1.37526071 Hassall L, Yara DA, Riches-Duit R, Rigsby P, Dobly A, Vermeulen M, Francotte A, Stickings P. Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines: ALTEX. 2023 Aug 7. doi: 10.14573/altex.2305251. Online ahead of print.37551090 Miller WG, Keller T, Budd J, Johansen JV, Panteghini M, Greenberg N, Delatour V, Ceriotti F, Deprez L, Rej R, Camara JE, MacKenzie F, Lyle AN, van der Hagen E, Burns C, Fauskanger P, Sandberg S; IFCC Working Group on Commutability in Metrological Traceability. Recommendations for Setting a Criterion for Assessing Commutability of Secondary Calibrator Certified Reference Materials: Clin Chem. 2023 Sep 1;69(9):966-975. doi: 10.1093/clinchem/hvad104.37566391 Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. 2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization: Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16.37584363 Shaw AG, Mampuela TK, Lofiko EL, Pratt C, Troman C, Bujaki E, O’Toole Á, Akello JO, Aziza AA, Lusamaki EK, Makangara JC, Akonga M, Lay Y, Nsunda B, White B, Jorgensen D, Pukuta E, Riziki Y, Rankin KE, Rambaut A, Ahuka-Mundeke S, Muyembe JJ, Martin J, Grassly NC, Mbala-Kingebeni P. Sensitive poliovirus detection using nested PCR and nanopore sequencing: a prospective validation study: Nat Microbiol. 2023 Sep;8(9):1634-1640. doi: 10.1038/s41564-023-01453-4. Epub 2023 Aug 17.37591995 Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L. 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine): Bioanalysis. 2023 Aug;15(16):955-1016. doi: 10.4155/bio-2023-0167. Epub 2023 Aug 31.37650500 Tierney R, Hockley J, Rajagopal S, Stickings P. Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test: Biologicals. 2023 Aug 30;84:101701. doi: 10.1016/j.biologicals.2023.101701. Online ahead of print.37657313 Komorowicz E, Farkas VJ, Szabó L, Cherrington S, Thelwell C, Kolev K. DNA and histones impair the mechanical stability and lytic susceptibility of fibrin formed by staphylocoagulase: Front Immunol. 2023 Aug 17;14:1233128. doi: 10.3389/fimmu.2023.1233128. eCollection 2023.37662916 Coxon CH, Rigsby P. Reproducibility and Harmonization in Research using Biological Standards: The Example of Platelet Agonist Collagen-Related Peptide: J Vis Exp. 2023 Aug 4;(198). doi: 10.3791/65410.37677022 Mooij P, Mortier D, Aartse A, Murad AB, Correia R, Roldão A, Alves PM, Fagrouch Z, Eggink D, Stockhofe N, Engelhardt OG, Verschoor EJ, van Gils MJ, Bogers WM, Carrondo MJT, Remarque EJ, Koopman G. Vaccine-induced neutralizing antibody responses to seasonal influenza virus H1N1 strains are not enhanced during subsequent pandemic H1N1 infection: Front Immunol. 2023 Aug 24;14:1256094. doi: 10.3389/fimmu.2023.1256094. eCollection 2023.37691927 Sandberg S, Fauskanger P, Johansen JV, Keller T, Budd J, Greenberg N, Rej R, Panteghini M, Delatour V, Ceriotti F, Deprez L, Camara JE, MacKenzie F, Lyle AN, van der Hagen E, Burns C, Greg Miller W; IFCC Working Group on Commutability in Metrological Traceability. Recommendations for Setting a Criterion and Assessing Commutability of Sample Materials Used in External Quality Assessment/Proficiency Testing Schemes: Clin Chem. 2023 Sep 19:hvad135. doi: 10.1093/clinchem/hvad135. Online ahead of print.37725906 Davlantes E, Jorba J, Henderson E, Bullard K, Deka MA, Kfutwah A, Martin J, Bessaud M, Shulman LM, Hawes K, Diop OM, Bandyopadhyay AS, Zipursky S, Burns CC. Notes from the Field: Circulating Vaccine-Derived Poliovirus Type 2 Emergences Linked to Novel Oral Poliovirus Vaccine Type 2 Use - Six African Countries, 2021-2023: MMWR Morb Mortal Wkly Rep. 2023 Sep 22;72(38):1041-1042. doi: 10.15585/mmwr.mm7238a4.37733626 MacLeod E, Rajagopal D, Vessillier S. Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety: J Vis Exp. 2023 Sep 15;(199). doi: 10.3791/65087.37782084 Cantoni D, Wilkie C, Bentley EM, Mayora-Neto M, Wright E, Scott S, Ray S, Castillo-Olivares J, Heeney JL, Mattiuzzo G, Temperton NJ. Correlation between pseudotyped virus and authentic virus neutralisation assays, a systematic review and meta-analysis of the literature: Front Immunol. 2023 Sep 18;14:1184362. doi: 10.3389/fimmu.2023.1184362. eCollection 2023.37790941 Jackson JW, Longstaff C, Woodle SA, Chang WC, Ovanesov MV. 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Creating resistance to avian influenza infection through genome editing of the ANP32 gene family: Nat Commun. 2023 Oct 10;14(1):6136. doi: 10.1038/s41467-023-41476-3.37816720 Andino R, Kirkegaard K, Macadam A, Racaniello VR, Rosenfeld AB. The Picornaviridae Family: Knowledge Gaps, Animal Models, Countermeasures, and Prototype Pathogens: J Infect Dis. 2023 Oct 18;228(Suppl 6):S427-S445. doi: 10.1093/infdis/jiac426.37849401 Ghosh S, Pawar R, Kangralkar V, Mallya AD, Dhere RM, Bolgiano B, Ravenscroft N. Acid hydrolysis conditions for quantification of meningococcal X polysaccharide in a pentavalent vaccine using HPAEC-PAD/ESI-MS: Anal Biochem. 2023 Dec 15;683:115363. doi: 10.1016/j.ab.2023.115363. Epub 2023 Oct 20.37866526 Bubba L, Benschop KSM, Blomqvist S, Duizer E, Martin J, Shaw AG, Bailly JL, Rasmussen LD, Baicus A, Fischer TK, Harvala H. Wastewater Surveillance in Europe for Non-Polio Enteroviruses and Beyond: Microorganisms. 2023 Oct 5;11(10):2496. doi: 10.3390/microorganisms11102496.37894154 Kamau E, Bessaud M, Majumdar M, Martin J, Simmonds P, Harvala H. Estimating prevalence of Enterovirus D111 in human and non-human primate populations using cross-sectional serology: J Gen Virol. 2023 Nov;104(11). doi: 10.1099/jgv.0.001915.37910158 Volle R, Luo L, Razafindratsimandresy R, Sadeuh-Mba SA, Gouandjika-Valisache I, Horwood P, Duong V, Buchy P, Joffret ML, Huang Z, Duizer E, Martin J, Chakrabarti LA, Dussart P, Jouvenet N, Delpeyroux F, Bessaud M. Neutralization of African enterovirus A71 genogroups by antibodies to canonical genogroups: J Gen Virol. 2023 Nov;104(11). doi: 10.1099/jgv.0.001911.37909282 Shaw HA, Remmington A, McKenzie G, Winkel C, Mawas F. 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2022

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10. Wood VE, Groves K, Wong LM, Kong L, Bird C, Wadhwa M, Quaglia M, Matejtschuk P, Dalby PA. Protein Engineering and HDX Identify Structural Regions of G-CSF Critical to Its Stability and Aggregation: Mol Pharm. 2022 Feb 7;19(2):616-629. doi: 10.1021/acs.molpharmaceut.1c00754. Epub 2021 Dec 29.34965730
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14. Ragotte RJ, Pulido D, Lias AM, Quinkert D, Alanine DGW, Jamwal A, Davies H, Nacer A, Lowe ED, Grime GW, Illingworth JJ, Donat RF, Garman EF, Bowyer PW, Higgins MK, Draper SJ. Heterotypic interactions drive antibody synergy against a malaria vaccine candidate: Nat Commun. 2022 Feb 17;13(1):933. doi: 10.1038/s41467-022-28601-4.35177602
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20. Cantoni D, Mayora-Neto M, Nadesalingam A, Wells DA, Carnell GW, Ohlendorf L, Ferrari M, Palmer P, Chan ACY, Smith P, Bentley EM, Einhauser S, Wagner R, Page M, Raddi G, Baxendale H, Castillo-Olivares J, Heeney J, Temperton N. Neutralisation Hierarchy of SARS-CoV-2 Variants of Concern Using Standardised, Quantitative Neutralisation Assays Reveals a Correlation With Disease Severity; Towards Deciphering Protective Antibody Thresholds: Front Immunol. 2022 Mar 7;13:773982. doi: 10.3389/fimmu.2022.773982. eCollection 2022.35330908
21. Mori F, Salvatore A, Ascione E, Di Marzo R, Fox B. Evaluation of prophylactic polyclonal anti-D antibodies: Differences in Fc-glycosylation in commercial products: Vox Sang. 2022 Apr;117(4):624-625. doi: 10.1111/vox.13213. Epub 2021 Oct 26.34699082
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52. Oddone I, Arsiccio A, Duru C, Malik K, Ferguson J, Pisano R, Matejtschuk P: Vacuum-Induced Surface Freezing for the Freeze-Drying of the Human Growth Hormone: How Does Nucleation Control Affect Protein Stability? Journal of Pharmaceutical Sciences 2020, 109(1):254-263 http://dx.doi.org/10.1016/j.xphs.2019.04.014
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2019

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2. Ashiru O, Esteso G, Garcia-Cuesta EM, Castellano E, Samba C, Escudero-Lopez E, Lopez-Cobo S, Alvarez-Maestro M, Linares A, Ho MM et al: BCG Therapy of Bladder Cancer Stimulates a Prolonged Release of the Chemoattractant CXCL10 (IP10) in Patient Urine. Cancers (Basel) 2019, 11(7) http://dx.doi.org/10.3390/cancers11070940 
3. Awanye AM, Chang CM, Wheeler JX, Chan H, Marsay L, Dold C, Rollier CS, Bird LE, Nettleship JE, Owens RJ et al: Immunogenicity profiling of protein antigens from capsular group B Neisseria meningitidis. Sci Rep 2019, 9(1):6843 http://dx.doi.org/10.1038/s41598-019-43139-0 
4. Barkoff AM, Mertsola J, Pierard D, Dalby T, Hoegh SV, Guillot S, Stefanelli P, van Gent M, Berbers G, Vestrheim D et al: Pertactin-deficient Bordetella pertussis isolates: evidence of increased circulation in Europe, 1998 to 2015. Euro Surveill 2019, 24(7) http://dx.doi.org/10.2807/1560-7917.ES.2019.24.7.1700832 
5. Berry N, Ferguson D, Ham C, Hall J, Jenkins A, Giles E, Devshi D, Kempster S, Rose N, Dowall S et al: High susceptibility, viral dynamics and persistence of South American Zika virus in New World monkey species. Sci Rep 2019, 9(1):14495 http://dx.doi.org/10.1038/s41598-019-50918-2 
6. Bhide Y, Dong W, Gribonika I, Voshart D, Meijerhof T, de Vries-Idema J, Norley S, Guilfoyle K, Skeldon S, Engelhardt OG et al: Cross-Protective Potential and Protection-Relevant Immune Mechanisms of Whole Inactivated Influenza Virus Vaccines Are Determined by Adjuvants and Route of Immunization. Front Immunol 2019, 10:646 http://dx.doi.org/10.3389/fimmu.2019.00646 
7. Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C et al: White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies’ Input on Bioanalysis, Biomarkers and Immunogenicity). Bioanalysis 2019, 11(23):2099-2132 http://dx.doi.org/10.4155/bio-2019-0270 
8. Borsetto C, Amos GCA, da Rocha UN, Mitchell AL, Finn RD, Laidi RF, Vallin C, Pearce DA, Newsham KK, Wellington EMH: Microbial community drivers of PK/NRP gene diversity in selected global soils. Microbiome 2019, 7(1):78 http://dx.doi.org/10.1186/s40168-019-0692-8 
9. Bricogne C, Fine M, Pereira PM, Sung J, Tijani M, Wang Y, Henriques R, Collins MK, Hilgemann DW: Author Correction: TMEM16F activation by Ca(2+) triggers plasma membrane expansion and directs PD-1 trafficking. Sci Rep 2019, 9(1):7705 http://dx.doi.org/10.1038/s41598-019-43808-0 
10. Bricogne C, Fine M, Pereira PM, Sung J, Tijani M, Wang Y, Henriques R, Collins MK, Hilgemann DW: TMEM16F activation by Ca(2+) triggers plasma membrane expansion and directs PD-1 trafficking. Sci Rep 2019, 9(1):619 http://dx.doi.org/10.1038/s41598-018-37056-x 
11. Brown JC, Barclay WS, Galiano M, Harvey R: Passage of influenza A/H3N2 viruses in human airway cells removes artefactual variants associated with neuraminidase-mediated binding. J Gen Virol 2019,  http://dx.doi.org/10.1099/jgv.0.001348 
12. Chan WY, Entwisle C, Ercoli G, Ramos-Sevillano E, McIlgorm A, Cecchini P, Bailey C, Lam O, Whiting G, Green N et al: A Novel, Multiple-Antigen Pneumococcal Vaccine Protects against Lethal Streptococcus pneumoniae Challenge. Infect Immun 2019, 87(3) http://dx.doi.org/10.1128/IAI.00846-18 
13. Chaskiel L, Bristow AD, Bluthe RM, Dantzer R, Blomqvist A, Konsman JP: Interleukin-1 reduces food intake and body weight in rat by acting in the arcuate hypothalamus. Brain Behav Immun 2019, 81:560-573 http://dx.doi.org/10.1016/j.bbi.2019.07.017 
14. Chen LM, Donis RO, Suarez DL, Wentworth DE, Webby R, Engelhardt OG, Swayne DE: Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses. Influenza Other Respir Viruses 2019,  http://dx.doi.org/10.1111/irv.12698 
15. Civoli F, Kasinath A, Cai XY, Wadhwa M, Exley A, Oldfield P, Alvandkouhi S, Schaffar G, Chappell J, Bowsher R et al: Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs. AAPS J 2019, 22(1):7 http://dx.doi.org/10.1208/s12248-019-0386-y 
16. Cowper B, Burns C, Bristow AF, Letallec D, Costanzo A: Assessment of methods for determination of glycan composition of erythropoietin. Pharmeur Bio Sci Notes 2019, 2019:34-53  
17. Cowper B, Hockley J, Partridge K, Ferguson J, Rigsby P, Burns C: The first World Health Organization International Standard for in vitro biological activity of darbepoetin. Biologicals 2019,  http://dx.doi.org/10.1016/j.biologicals.2019.12.004 
18. Cowper B, Laven M, Hakkarainen B, Mulugeta E: Glycan analysis of erythropoiesis-stimulating agents. J Pharm Biomed Anal 2019, 180:113031 http://dx.doi.org/10.1016/j.jpba.2019.113031 
19. Coxon CH, Longstaff C, Burns C: Applying the science of measurement to biology: Why bother? PLoS Biol 2019, 17(6):e3000338 http://dx.doi.org/10.1371/journal.pbio.3000338 
20. De Leoz MLA, Duewer DL, Fung A, Liu L, Yau HK, Potter O, Staples GO, Furuki K, Frenkel R, Hu Y et al: NIST Interlaboratory Study on Glycosylation Analysis of Monoclonal Antibodies: Comparison of Results from Diverse Analytical Methods. Mol Cell Proteomics 2019,  http://dx.doi.org/10.1074/mcp.RA119.001677 
21. De Niz M, Nacer A, Frischknecht F: Intravital microscopy: Imaging host-parasite interactions in the brain. Cell Microbiol 2019, 21(5):e13024 http://dx.doi.org/10.1111/cmi.13024 
22. Douglas-Bardsley A, Asokanathan C, Tierney S, Hockley J, Markey K: Collaborative study for the calibration of the replacement International Standard for pertussis toxin for use in histamine sensitisation and CHO cell clustering assays. Biologicals 2019, 62:85-92 http://dx.doi.org/10.1016/j.biologicals.2019.09.001 
23. Duralliu A, Matejtschuk P, Dubey S, Koroma H, Gubinelli F, Williams DR: The influence of the closure format on the storage stability and moisture content of freeze-dried influenza antigen. Vaccine 2019, 37(32):4485-4490 http://dx.doi.org/10.1016/j.vaccine.2019.06.070 
24. Duralliu A, Matejtschuk P, Williams DR: Measuring the specific surface area (SSA) of freeze-dried biologics using inverse gas chromatography. Eur J Pharm Biopharm 2019, 142:216-221 http://dx.doi.org/10.1016/j.ejpb.2019.06.026 
25. Evangelopoulos D, Prosser GA, Rodgers A, Dagg BM, Khatri B, Ho MM, Gutierrez MG, Cortes T, de Carvalho LPS: Comparative fitness analysis of D-cycloserine resistant mutants reveals both fitness-neutral and high-fitness cost genotypes. Nat Commun 2019, 10(1):4177 http://dx.doi.org/10.1038/s41467-019-12074-z 
26. Faleye TOC, Adewumi OM, Klapsa D, Majumdar M, Martin J, Adeniji JA: Genome Sequences of Two Dual-Serotype-Specific Echovirus 20 Strains from Nigeria. Microbiol Resour Announc 2019, 8(43) http://dx.doi.org/10.1128/MRA.00894-19 
27. Faulds-Pain A, Shaw HA, Terra VS, Kellner S, Brockmeier SL, Wren BW: The Streptococcos suis sortases SrtB and SrtF are essential for disease in pigs. Microbiology 2019, 165(2):163-173 http://dx.doi.org/10.1099/mic.0.000752 
28. Ferguson J, Burns CJ, Regourd E, Costanzo A: Collaborative study for the establishment of erythropoietin BRP batch 5. Pharmeur Bio Sci Notes 2019, 2019:27-33  
29. Ferguson J, Patel D, Atkinson E, Rigsby P, Burns C: Continued provision of WHO International Standards for total and free PSA: Content and commutability of replacement preparations. Clin Biochem 2019, 71:58-66 http://dx.doi.org/10.1016/j.clinbiochem.2019.07.007 
30. Fitzpatrick M, Ho MM, Clark S, Dagg B, Khatri B, Lanni F, Williams A, Brennan M, Laddy D, Walker B: Comparison of pellicle and shake flask-grown BCG strains by quality control assays and protection studies. Tuberculosis (Edinb) 2019, 114:47-53 http://dx.doi.org/10.1016/j.tube.2018.10.013 
31. Fox B, Hockley J, Studholme L: The British Standard for (European Conformity[CE] Marked) Anti-D: Its rarely discussed but important role in quantitating anti-D in patient plasma. Transfus Med 2019,  http://dx.doi.org/10.1111/tme.12649 
32. Fox B, Sharp G, Atkinson E, Roberts G, Rigsby P, Studholme L: The third international standard for anti-D immunoglobulin: international collaborative study to evaluate candidate preparations. Vox Sang 2019, 114(7):740-748 http://dx.doi.org/10.1111/vox.12822 
33. Fox BJ, Hockley J, Rigsby P, Dolman C, Meroni PL, Ronnelid J: A WHO Reference Reagent for lupus (anti-dsDNA) antibodies: international collaborative study to evaluate a candidate preparation. Ann Rheum Dis 2019, 78(12):1677-1680 http://dx.doi.org/10.1136/annrheumdis-2019-215845 
34. Gao F, Swann C, Rigsby P, Rijpkema S, Lockyer K, Logan A, Bolgiano B, Vi ISWG: Evaluation of two WHO First International Standards for Vi polysaccharide from Citrobacter freundii and Salmonella enterica subspecies enterica serovar Typhi. Biologicals 2019, 57:34-45 http://dx.doi.org/10.1016/j.biologicals.2018.11.004 
35. Gao J, Couzens L, Burke DF, Wan H, Wilson P, Memoli MJ, Xu X, Harvey R, Wrammert J, Ahmed R et al: Antigenic Drift of the Influenza A(H1N1)pdm09 Virus Neuraminidase Results in Reduced Effectiveness of A/California/7/2009 (H1N1pdm09)-Specific Antibodies. mBio 2019, 10(2) http://dx.doi.org/10.1128/mBio.00307-19 
36. Govind S, Hockley J, Morris C, Almond N, Collaborative Study G: The development and establishment of the 1st WHO BKV International Standard for nucleic acid based techniques. Biologicals 2019, 60:75-84 http://dx.doi.org/10.1016/j.biologicals.2019.04.004 
37. Gray E, Kitchen S, Bowyer A, Chowdary P, Jenkins PV, Murphy P, Platton S, Riddell A, Lester W: Laboratory measurement of factor replacement therapies in the treatment of congenital haemophilia: A United Kingdom Haemophilia Centre Doctors’ Organisation guideline. Haemophilia 2019,  http://dx.doi.org/10.1111/hae.13907 
38. Gu B, Piebalgs A, Huang Y, Longstaff C, Hughes AD, Chen R, Thom SA, Xu XY: Mathematical Modelling of Intravenous Thrombolysis in Acute Ischaemic stroke: Effects of Dose Regimens on Levels of Fibrinolytic Proteins and Clot Lysis Time. Pharmaceutics 2019, 11(3) http://dx.doi.org/10.3390/pharmaceutics11030111 
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40. Gurjar SA, Wheeler JX, Wadhwa M, Thorpe R, Kimber I, Derrick JP, Dearman RJ, Metcalfe C: The impact of thioredoxin reduction of allosteric disulfide bonds on the therapeutic potential of monoclonal antibodies. J Biol Chem 2019, 294(51):19616-19634 http://dx.doi.org/10.1074/jbc.RA119.010637 
41. Harvey R, Mattiuzzo G, Hassall M, Sieberg A, Muller MA, Drosten C, Rigsby P, Oxenford CJ, Caly L, Li C et al: Comparison of Serologic Assays for Middle East Respiratory Syndrome Coronavirus. Emerging Infectious Diseases 2019, 25(10):1878-1883 http://dx.doi.org/10.3201/eid2510.190497 
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43. Hayes A, Nguyen D, Andersson M, Anton A, Bailly JL, Beard S, Benschop KSM, Berginc N, Blomqvist S, Cunningham E et al: A European multi-centre evaluation of detection and typing methods for human enteroviruses and parechoviruses using RNA transcripts. J Med Virol 2019,  http://dx.doi.org/10.1002/jmv.25659 
44. Hellen N, Pinto Ricardo C, Vauchez K, Whiting G, Wheeler JX, Harding SE: Proteomic Analysis Reveals Temporal Changes in Protein Expression in Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes In Vitro. Stem Cells Dev 2019, 28(9):565-578 http://dx.doi.org/10.1089/scd.2018.0210 
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48. Hubbard AR, Haberichter SL, ISTH SSCsovWfot: Establishment of an International Reference Reagent for standardization of von Willebrand factor binding to recombinant glycoprotein Ib (VWF:GPIbM and VWF:GPIbR): Official Communication of the SSC. J Thromb Haemost 2019, 17(6):1003-1005 http://dx.doi.org/10.1111/jth.14429 
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50. Hussain S, Turnbull ML, Pinto RM, McCauley JW, Engelhardt OG, Digard P: Segment 2 from influenza A(H1N1) 2009 pandemic viruses confers temperature-sensitive haemagglutinin yield on candidate vaccine virus growth in eggs that can be epistatically complemented by PB2 701D. J Gen Virol 2019, 100(7):1079-1092 http://dx.doi.org/10.1099/jgv.0.001279 
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52. Jenkins A, Govind S, Morris C, Berry N: Complete Genome Sequence of Original Material Used To Derive the WHO International Standard for Human Polyomavirus BK DNA. Microbiol Resour Announc 2019, 8(43) http://dx.doi.org/10.1128/MRA.00911-19 
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68. Matejtschuk P, Duru C, Malik KP, Bristow AF, Costanzo A, Burns CJ: Development of a stable chemically cross-linked erythropoietin dimer for use in the quality control of erythropoietin therapeutic products. Anal Bioanal Chem 2019, 411(13):2755-2758 http://dx.doi.org/10.1007/s00216-019-01768-4 
69. Matejtschuk P. MK, Duru C: Formulation and Process Development for Lyophilized Biological Reference Material. Lyophilization of Pharmaceuticals and Biologicals 2019, Methods in Pharmacology and Toxicology, Humana Press, New York, NY  
70. Mattiuzzo G, Bentley EM, Page M: The Role of Reference Materials in the Research and Development of Diagnostic Tools and Treatments for Haemorrhagic Fever Viruses. Viruses 2019, 11(9) http://dx.doi.org/10.3390/v11090781 
71. Mattiuzzo G, Knezevic I, Hassall M, Ashall J, Myhill S, Faulkner V, Hockley J, Rigsby P, Wilkinson DE, Page M et al: Harmonization of Zika neutralization assays by using the WHO International Standard for anti-Zika virus antibody. NPJ Vaccines 2019, 4:42 http://dx.doi.org/10.1038/s41541-019-0135-3 
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83. Oddone I, Arsiccio A, Duru C, Malik K, Ferguson J, Pisano R, Matejtschuk P: Vacuum-Induced Surface Freezing for the Freeze-Drying of the Human Growth Hormone: How Does Nucleation Control Affect Protein Stability? J Pharm Sci 2019,  http://dx.doi.org/10.1016/j.xphs.2019.04.014 
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87. Proudfoot AEI, Wadhwa M: WHO International Standards and Reference Preparations for Cytokines and Growth Factors. J Interferon Cytokine Res 2019, 39(7):438-439 http://dx.doi.org/10.1089/jir.2019.0078 
88. Ramage W, Gaiotto T, Ball C, Risley P, Carnell GW, Temperton N, Cheung CY, Engelhardt OG, Hufton SE: Cross-Reactive and Lineage-Specific Single Domain Antibodies against Influenza B Hemagglutinin. Antibodies (Basel) 2019, 8(1) http://dx.doi.org/10.3390/antib8010014 
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90. Riches-Duit R, Hassall L, Rigsby P, Stickings P: Evaluation of a capture antigen ELISA for the characterisation of tetanus vaccines for veterinary use. Biologicals 2019, 61:8-14 http://dx.doi.org/10.1016/j.biologicals.2019.08.003 
91. Robinson MJ, Matejtschuk P, Longstaff C, Dalby PA: Selective Stabilization and Destabilization of Protein Domains in Tissue-Type Plasminogen Activator Using Formulation Excipients. Mol Pharm 2019, 16(2):744-755 http://dx.doi.org/10.1021/acs.molpharmaceut.8b01024 
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2018

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2. Adhya D, Annuario E, Lancaster MA, Price J, Baron-Cohen S, Srivastava DP: Understanding the role of steroids in typical and atypical brain development: Advantages of using a "brain in a dish" approach. J Neuroendocrinol 2018, 30(2) http://dx.doi.org/10.1111/jne.12547
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4. Barkoff AM, Mertsola J, Pierard D, Dalby T, Hoegh SV, Guillot S, Stefanelli P, van Gent M, Berbers G, Vestrheim DF et al: Surveillance of Circulating Bordetella pertussis Strains in Europe during 1998 to 2015. J Clin Microbiol 2018, 56(5) http://dx.doi.org/10.1128/JCM.01998-17
5. Bryan P, Seabroke S, Wong J, Donegan K, Webb E, Goldsmith C, Vipond C, Feavers I: Safety of multicomponent meningococcal group B vaccine (4CMenB) in routine infant immunisation in the UK: a prospective surveillance study. Lancet Child Adolesc Health 2018, 2(6):395-403 http://dx.doi.org/10.1016/S2352-4642(18)30103-2
6. Budd JR, Weykamp C, Rej R, MacKenzie F, Ceriotti F, Greenberg N, Camara JE, Schimmel H, Vesper HW, Keller T et al: IFCC Working Group Recommendations for Assessing Commutability Part 3: Using the Calibration Effectiveness of a Reference Material. Clin Chem 2018, 64(3):465-474 http://dx.doi.org/10.1373/clinchem.2017.277558
7. Capone A, Lo Presti A, Sernicola L, Farcomeni S, Ferrantelli F, Maggiorella MT, Mee ET, Rose NJ, Cella E, Ciccozzi M et al: Genetic diversity in the env V1-V2 region of proviral quasispecies from long-term controller MHC-typed cynomolgus macaques infected with SHIVSF162P4cy. J Gen Virol 2018, 99(12):1717-1728 http://dx.doi.org/10.1099/jgv.0.001159
8. Chan WY, Entwisle C, Ercoli G, Ramos-Sevillano E, McIlgorm A, Cecchini P, Bailey C, Lam O, Whiting G, Green N et al: A novel, multiple-antigen pneumococcal vaccine protects against lethal Streptococcus pneumoniae challenge. Infect Immun 2018 http://dx.doi.org/10.1128/IAI.00846-18
9. Claessens A, Harris LM, Stanojcic S, Chappell L, Stanton A, Kuk N, Veneziano-Broccia P, Sterkers Y, Rayner JC, Merrick CJ: RecQ helicases in the malaria parasite Plasmodium falciparum affect genome stability, gene expression patterns and DNA replication dynamics. PLoS genetics 2018, 14(7):e1007490 http://dx.doi.org/10.1371/journal.pgen.1007490
10. Cole H, Bryan D, Lancaster L, Mawas F, Vllasaliu D: Chitosan nanoparticle antigen uptake in epithelial monolayers can predict mucosal but not systemic in vivo immune response by oral delivery. Carbohydr Polym 2018, 190:248-254 http://dx.doi.org/10.1016/j.carbpol.2018.02.084
11. Cooper G, Mao Q, Crawt L, Wang Y, Dougall T, Rigsby P, Liang Z, Xu M, Collaborative Study G, Minor P et al: Establishment of the 1st WHO International Standard for anti-EV71 serum (Human). Biologicals 2018, 53:39-50 http://dx.doi.org/10.1016/j.biologicals.2018.03.001
12. Cowper B, Li X, Yu L, Zhou Y, Fan WH, Rao CM: Comprehensive glycan analysis of twelve recombinant human erythropoietin preparations from manufacturers in China and Japan. J Pharm Biomed Anal 2018, 153:214-220 http://dx.doi.org/10.1016/j.jpba.2018.02.043
13. D’Alessio F, Koopman G, Houard S, Remarque EJ, Stockhofe N, Engelhardt OG: Workshop report: Experimental animal models for universal influenza vaccines. Vaccine 2018, 36(46):6895-6901 http://dx.doi.org/10.1016/j.vaccine.2018.10.024
14. Dong W, Bhide Y, Sicca F, Meijerhof T, Guilfoyle K, Engelhardt OG, Boon L, de Haan CAM, Carnell G, Temperton N et al: Cross-Protective Immune Responses Induced by Sequential Influenza Virus Infection and by Sequential Vaccination With Inactivated Influenza Vaccines. Front Immunol 2018, 9:2312 http://dx.doi.org/10.3389/fimmu.2018.02312
15. Duralliu A, Matejtschuk P, Williams DR: Humidity induced collapse in freeze dried cakes: A direct visualization study using DVS. Eur J Pharm Biopharm 2018, 127:29-36 http://dx.doi.org/10.1016/j.ejpb.2018.02.003
16. Edwards LA, Nowocin AK, Jafari NV, Meader LL, Brown K, Sarde A, Lam C, Murray A, Wong W: Chronic Rejection of Cardiac Allografts Is Associated With Increased Lymphatic Flow and Cellular Trafficking. Circulation 2018, 137(5):488-503 http://dx.doi.org/10.1161/CIRCULATIONAHA.117.02853
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2017 

1. Abou-El-Enein M, Cathomen T, Ivics Z, June CH, Renner M, Schneider CK, Bauer G: Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment. Cell Stem Cell 2017, 21(4):427-430 http://dx.doi.org/10.1016/j.stem.2017.09.007
2. Alampalli SV, Thomson MM, Sampathkumar R, Sivaraman K, U KJA, Dhar C, G DS, Berry N, Vyakarnam A: Deep sequencing of near full-length HIV-1 genomes from plasma identifies circulating subtype C and infrequent occurrence of AC recombinant form in Southern India. PLoS One 2017, 12(12):e0188603 http://dx.doi.org/10.1371/journal.pone.0188603
3. Andrews PW, Ben-David U, Benvenisty N, Coffey P, Eggan K, Knowles BB, Nagy A, Pera M, Reubinoff B, Rugg-Gunn PJ et al: Assessing the Safety of Human Pluripotent Stem Cells and Their Derivatives for Clinical Applications. Stem Cell Reports 2017, 9(1):1-4 http://dx.doi.org/10.1016/j.stemcr.2017.05.029
4. Asokanathan C, Tierney S, Ball CR, Buckle G, Day A, Tanley S, Bristow A, Markey K, Xing D, Yuen CT: An ELISA method to estimate the mono ADP-ribosyltransferase activities: e.g in pertussis toxin and vaccines. Anal Biochem 2017, 540-541:15-19 http://dx.doi.org/10.1016/j.ab.2017.10.025
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2016 

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2015 

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