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 2021-09-01 to 2025-09-01.)
ArticleCitations
Aims and Scope/Editorial Board/Publishing Details22
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop21
EGF domain peptide of Developmentally regulated endothelial locus1 facilitates gene expression of extracellularly applied plasmid DNA17
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model12
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques12
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops12
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA11
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis11
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression11
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency11
Aims and Scope/Editorial Board/Publishing Details10
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions9
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines9
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report9
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus8
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report8
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab8
Animal cell substrates for the production of biologicals: An introduction to WHO documents8
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report8
Replacement of in vivo leptospirosis vaccine potency testing in the United States8
Vaccination and surveillance for high pathogenicity avian influenza in poultry—current situation and perspectives8
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics7
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals7
IABS/DCVMN webinar on next generation sequencing7
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report7
Establishing potency and stability release specifications using alternative ATP assay of BCG Tokyo 172-1 vaccine used in Thailand7
A rapid and simple sterility test method based on solid culture medium containing blood6
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 virus6
Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine6
Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus6
Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y6
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology5
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
Aims and Scope/Editorial Board/Publishing Details5
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
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing5
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines4
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines4
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
Aims and Scope/Editorial Board/Publishing Details4
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era3
Enabling the evaluation of COVID-19 vaccines with correlates of protection3
Glycoconjugate content quantification to assess vaccine potency: A simplified approach3
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report3
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation3
Development of an optimized RT-LAMP test for the detection of SARS-CoV-23
Aims and Scope/Editorial Board/Publishing Details3
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities3
Aims and Scope/Editorial Board/Publishing Details3
Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays3
Evolution of FMT – From early clinical to standardized treatments3
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
Obituary - Inessa LEVENBOOK: 1926–20223
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
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China2
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
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response2
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 tools2
Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses2
Advances in mRNA vaccine research in the field of quality control2
Development and evaluation of recombinant gD protein based ELISA for sero-surveillance of BoHV-1 in India2
A vision for patient-centric specifications for biologicals2
The current status of the biosimilars landscape in China2
Klebsiella pneumoniae vaccine studies in animal models2
Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market integration2
An optimized microplate-based method to evaluate complement-dependent hemolysis mediated by intravenous immunoglobulins (IVIG)2
Aims and Scope/Editorial Board/Publishing Details2
Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure2
Corrigendum to “Vaccination and surveillance for high pathogenicity avian influenza in poultry-current situation and perspectives” [Biologicals 91 (2025) 101840]2
Evaluation of DF-1 cell culture based vaccine development for infectious bursal disease virus in Ethiopia2
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 20212
Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness2
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization2
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing2
Autogenous vaccines: Quality of production and movement in a common market2
A meta-analysis to re-evaluate the sensitivity and specificity of FMDV NSP ELISA tests2
Accelerated national lot release on COVID-19 vaccines in Republic of Korea2
A gaps-and-needs analysis of vaccine R&D in Europe: Recommendations to improve the research infrastructure2
Regulatory changes during the Covid-19 pandemic: A comparative review of the European Union and Brazilian regulations for biological and biotechnological products2
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
Aims and Scope/Editorial Board/Publishing Details2
Evaluation of 1st WHO anti-malaria reference reagent for competition ELISA harmonisation and development of ADAMSEL analytical platform2
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
Histological and functional exploration of platelet activity post-SARS-CoV-2 vaccination1
Development and characterization of mouse monoclonal antibodies to canine morbillivirus1
Corrigendum to “Comparison of Astra Zeneca and sinopharm vaccines as boosters in protection against COVID-19 infection” [Biologicals 82 (2023) 101668]1
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
Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states1
An alternative In vitro method for evaluation of inactivated infectious bronchitis (IB) vaccines1
Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea1
Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 20231
CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells1
Development and validation of a spectrophotometric method for quantification of residual cyclodextrin (DIMEB; Heptakis) in pertussis antigens1
Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report1
A collaborative study to establish the second national standard for antithrombin concentrate in Korea1
Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice1
Expression, purification, and immunogenicity study of human papillomavirus type 52 virus-like particles produced in Hansenula polymorpha1
Development and optimization of multiplex PCR for rapid detection of type I-F1 and type I-F2 Cas cluster genes in Acinetobacter baumannii1
Efficient extraction of adventitious virus nucleic acid using commercially available methods1
Molecular characteristics of feline coronavirus in South Korea, 2016–20231
Modeling the long-term 2-8 °C stability profiles of a live, rotavirus vaccine candidate (RV3-BB) in various liquid formulations via extrapolations of real-time and accelerated stability data1
It is time to reconsider the use of naturally-occurring endotoxins in endotoxin recovery studies: Part 2 of a BioPhorum harmonized endotoxin recovery study1
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
Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & 5, 20211
An indirect ELISA for detecting anti-SARS-CoV-2 antibodies in human sera using a baculovirus-expressed recombinant nucleocapsid antigen1
Aims and Scope/Editorial Board/Publishing Details1
Emergence of SARS-CoV-2 variant of interest B.1.525 (Eta) in Bangladesh1
Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean1
Emerging genetic diversity of SARS-CoV-2 RNA dependent RNA polymerase (RdRp) alters its B-cell epitopes1
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain1
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