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 2021-05-01 to 2025-05-01.)
ArticleCitations
EGF domain peptide of Developmentally regulated endothelial locus1 facilitates gene expression of extracellularly applied plasmid DNA19
Aims and Scope/Editorial Board/Publishing Details18
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops12
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop11
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques10
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression9
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency9
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA9
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model9
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis8
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus8
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab8
Aims and Scope/Editorial Board/Publishing Details8
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions8
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines7
Animal cell substrates for the production of biologicals: An introduction to WHO documents7
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report7
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report7
IABS/DCVMN webinar on next generation sequencing6
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report6
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics6
Replacement of in vivo leptospirosis vaccine potency testing in the United States6
Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y6
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
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals6
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report5
Glycoconjugation of Shigella flexneri type 2a O-polysaccharide with CRM197 as a potential vaccine candidate for shigellosis5
Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine5
Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus5
A rapid and simple sterility test method based on solid culture medium containing blood5
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
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 virus4
IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?4
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology4
Aims and Scope/Editorial Board/Publishing Details4
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing4
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody4
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients4
An adventitious agent-free clonal cell line that is highly susceptible to foot -and-mouth disease virus4
Aims and Scope/Editorial Board/Publishing Details3
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines3
Glycoconjugate content quantification to assess vaccine potency: A simplified approach3
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era3
Obituary - Inessa LEVENBOOK: 1926–20223
Evolution of FMT – From early clinical to standardized treatments3
Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay3
Animal experiments show impact of vaccination on reduction of SARS-CoV-2 virus circulation: A model for vaccine development?3
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
Enabling the evaluation of COVID-19 vaccines with correlates of protection3
Aims and Scope/Editorial Board/Publishing Details3
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation3
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines3
Aims and Scope/Editorial Board/Publishing Details3
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report3
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
Aims and Scope/Editorial Board/Publishing Details3
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing3
Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays3
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