Biologicals

Papers
(The TQCC of Biologicals is 3. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2021-06-01 to 2025-06-01.)
ArticleCitations
Aims and Scope/Editorial Board/Publishing Details19
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops19
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop13
EGF domain peptide of Developmentally regulated endothelial locus1 facilitates gene expression of extracellularly applied plasmid DNA11
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model11
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques11
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency10
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA9
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis9
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab8
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus8
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions8
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression8
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report8
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines8
Aims and Scope/Editorial Board/Publishing Details8
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report8
Animal cell substrates for the production of biologicals: An introduction to WHO documents8
Replacement of in vivo leptospirosis vaccine potency testing in the United States7
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals7
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report7
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics7
Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y6
Glycoconjugation of Shigella flexneri type 2a O-polysaccharide with CRM197 as a potential vaccine candidate for shigellosis6
A rapid and simple sterility test method based on solid culture medium containing blood6
IABS/DCVMN webinar on next generation sequencing6
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report6
Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine6
Detection of hepatitis C virus and parvovirus B19 in human plasma pools by nucleic-acid amplification techniques – Trends in results of EDQM proficiency testing studies from 2004 to 20186
An adventitious agent-free clonal cell line that is highly susceptible to foot -and-mouth disease virus5
Aims and Scope/Editorial Board/Publishing Details5
In silico discovery of epitopes of gag and env proteins for the development of a multi-epitope vaccine candidate against Maedi Visna Virus using reverse vaccinology approach5
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology5
Development and evaluation of an external quality control and internal quality control containing real-time RT-PCR assay for the detection of o'nyong-nyong virus5
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients5
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody5
Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus5
Aims and Scope/Editorial Board/Publishing Details4
Animal experiments show impact of vaccination on reduction of SARS-CoV-2 virus circulation: A model for vaccine development?4
IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?4
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing4
Aims and Scope/Editorial Board/Publishing Details4
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines4
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines4
Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay3
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report3
Development of an optimized RT-LAMP test for the detection of SARS-CoV-23
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era3
Aims and Scope/Editorial Board/Publishing Details3
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities3
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report3
Obituary - Inessa LEVENBOOK: 1926–20223
Evolution of FMT – From early clinical to standardized treatments3
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing3
Aims and Scope/Editorial Board/Publishing Details3
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities3
Enabling the evaluation of COVID-19 vaccines with correlates of protection3
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation3
Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays3
Klebsiella pneumoniae vaccine studies in animal models3
Glycoconjugate content quantification to assess vaccine potency: A simplified approach3
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