- 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. Sources of bias and limitations of thrombinography: inner filter effect and substrate depletion at the edge of failure algorithm: Thromb J. 2023 Oct 4;21(1):104. doi: 10.1186/s12959-023-00549-5.37794418
- Shim SB, Choi CW, Shin JH, Kim JW, Schepelmann S, Jung JH, Chander H, Pujilestari R, Kuramitsu M, Ochiai M, Qi NY, Dimapilis GN, Dung LT, Moon HS, Shin IS. Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states: Biologicals. 2023 Nov;84:101712. doi: 10.1016/j.biologicals.2023.101712. Epub 2023 Oct 3.37797484
- Idoko-Akoh A, Goldhill DH, Sheppard CM, Bialy D, Quantrill JL, Sukhova K, Brown JC, Richardson S, Campbell C, Taylor L, Sherman A, Nazki S, Long JS, Skinner MA, Shelton H, Sang HM, Barclay WS, McGrew MJ. 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. Mucosal Immunization Has Benefits over Traditional Subcutaneous Immunization with Group A Streptococcus Antigens in a Pilot Study in a Mouse Model: Vaccines (Basel). 2023 Nov 17;11(11):1724. doi: 10.3390/vaccines11111724.38006056
- Raska A, Kálmán K, Egri B, Csikós P, Beinrohr L, Szabó L, Tenekedjiev K, Nikolova N, Longstaff C, Roberts I, Kolev K, Wohner N. Synergism of red blood cells and tranexamic acid in the inhibition of fibrinolysis: J Thromb Haemost. 2023 Nov 26:S1538-7836(23)00847-4. doi: 10.1016/j.jtha.2023.11.009. Online ahead of print.38016517
- Lamaudière MTF, Turner MC, Arasaradnam RP, Morozov I. Human gut microbiota and endocrinology: paradigm shift from genome to its regulation: J Endocrinol. 2023 Dec 1:JOE-23-0348. doi: 10.1530/JOE-23-0348. Online ahead of print.38113381
- van den Besselaar AMHP, Stavelin A, Kitchen S, Bryant M, Tripodi A, Scalambrino E, Clerici M, Herbel P, Jünschke A, Meyer Dos Santos S, Meijer P, Niessen RWLM, Meijers JCM, Thelwell C, Cuker A, Kung C, Cao Z, Zander N, Iwasaki Y, Depasse F, van Rijn C, Baktawar S, Abdoel C, Cobbaert CM. Defining a metrologically traceable and sustainable calibration hierarchy of International Normalized Ratio (INR) for monitoring of vitamin K antagonist treatment in accordance with International Standard ISO 17511:2020: Communication from the IFCC-SSC/ISTH working group on PT/INR standardization: J Thromb Haemost. 2023 Dec 19:S1538-7836(23)00911-X. doi: 10.1016/j.jtha.2023.12.013. Online ahead of print.38128762
- Graham VA, Easterbrook L, Kennedy E, Rayner E, Findlay-Wilson S, Flett L, Wise EL, Treagus S, Fotheringham S, Kempster S, Almond N, Dowall S. Pathogenesis of Rift Valley Fever Virus in a BALB/c Mouse Model Is Affected by Virus Culture Conditions and Sex of the Animals: Viruses. 2023 Nov 30;15(12):2369. doi: 10.3390/v15122369.38140610
|