Biologicals

Papers
(The median citation count of Biologicals is 1. 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
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
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression9
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
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
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
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines7
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
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
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
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
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
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
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
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
Advances in mRNA vaccine research in the field of quality control2
An optimized microplate-based method to evaluate complement-dependent hemolysis mediated by intravenous immunoglobulins (IVIG)2
A practical approach for gmp-compliant validation of real-time PCR method for mycoplasma detection in human mesenchymal stromal cells as advanced therapy medicinal product2
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China2
Klebsiella pneumoniae vaccine studies in animal models2
Expression and purification of Hepatitis B virus core antigen using Escherichia coli and its utilization for the diagnosis of Hepatitis B virus infections2
Viral clearance capability of monoclonal antibody purification2
Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure2
Collaborative study on the cross-reactivity of two influenza B viral components in single radial immunodiffusion assay using quadrivalent influenza vaccines in Japan from 2015/16 to 2021–22 influenza 2
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response2
The current status of the biosimilars landscape in China2
A vision for patient-centric specifications for biologicals2
Development of an optimized RT-LAMP test for the detection of SARS-CoV-22
Autogenous vaccines: Quality of production and movement in a common market2
Accelerated national lot release on COVID-19 vaccines in Republic of Korea2
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 20212
Aims and Scope/Editorial Board/Publishing Details2
Corrigendum to “Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean” [Biologicals 90 (2025) 101826]2
Aims and Scope/Editorial Board/Publishing Details2
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization2
Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness2
Identification of contaminating mollicutes in mammalian cell culture as spiroplasma species2
Development and evaluation of recombinant gD protein based ELISA for sero-surveillance of BoHV-1 in India2
Immunization effect of lipopolysaccharide antigen in conjugation with PLGA nanoparticles as a nanovaccine against Brucella melitensis infection2
Evaluation of DF-1 cell culture based vaccine development for infectious bursal disease virus in Ethiopia2
Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean1
Expression, purification, and immunogenicity study of human papillomavirus type 52 virus-like particles produced in Hansenula polymorpha1
Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & 5, 20211
Infectivity assessment of porcine endogenous retrovirus using high-throughput sequencing technologies1
An indirect ELISA for detecting anti-SARS-CoV-2 antibodies in human sera using a baculovirus-expressed recombinant nucleocapsid antigen1
Regulatory changes during the Covid-19 pandemic: A comparative review of the European Union and Brazilian regulations for biological and biotechnological products1
Aims and Scope/Editorial Board/Publishing Details1
Report on the GHPP-BloodTrain online workshop on “Authorisation and Licensing of Blood Establishments - Review of quality documentation of blood and blood components”, 5th-8th of July 20211
Efficient extraction of adventitious virus nucleic acid using commercially available methods1
Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea1
An alternative In vitro method for evaluation of inactivated infectious bronchitis (IB) vaccines1
Development and optimization of multiplex PCR for rapid detection of type I-F1 and type I-F2 Cas cluster genes in Acinetobacter baumannii1
A gaps-and-needs analysis of vaccine R&D in Europe: Recommendations to improve the research infrastructure1
Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses1
Emerging genetic diversity of SARS-CoV-2 RNA dependent RNA polymerase (RdRp) alters its B-cell epitopes1
Development and characterization of mouse monoclonal antibodies to canine morbillivirus1
A collaborative study to establish the second national standard for antithrombin concentrate in Korea1
Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states1
Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice1
Aims and Scope/Editorial Board/Publishing Details1
Molecular characterization of Anaplasma ovis Msp4 protein in strains isolated from ticks in Turkey: A multi-epitope synthetic vaccine antigen design against Anaplasma ovis using immunoinformatic tools1
Aims and Scope/Editorial Board/Publishing Details1
Antivenoms, hepatitis B vaccine and oral polio vaccine can be considered for storage and handling outside the cold chain following the innovative ‘controlled temperature chain’ approach1
Aims and Scope/Editorial Board/Publishing Details1
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