OOIR: Observatory of International Research

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 2021-07-01 to 2025-07-01.)

Article	Citations
Aims and Scope/Editorial Board/Publishing Details	20
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop	19
EGF domain peptide of Developmentally regulated endothelial locus1 facilitates gene expression of extracellularly applied plasmid DNA	15
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency	11
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops	11
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model	11
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis	11
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques	11
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression	10
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA	10
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines	9
Aims and Scope/Editorial Board/Publishing Details	9
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report	8
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus	8
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions	8
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab	8
IABS/DCVMN webinar on next generation sequencing	7
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics	7
Replacement of in vivo leptospirosis vaccine potency testing in the United States	7
Animal cell substrates for the production of biologicals: An introduction to WHO documents	7
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report	7
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	7
Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y	6
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 approach	6
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals	6

Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report	6
Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus	6
Glycoconjugation of Shigella flexneri type 2a O-polysaccharide with CRM197 as a potential vaccine candidate for shigellosis	6
Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine	6
A rapid and simple sterility test method based on solid culture medium containing blood	6
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 virus	5
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients	5
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology	5
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody	5
Aims and Scope/Editorial Board/Publishing Details	5
An adventitious agent-free clonal cell line that is highly susceptible to foot -and-mouth disease virus	5
Aims and Scope/Editorial Board/Publishing Details	4
Glycoconjugate content quantification to assess vaccine potency: A simplified approach	4
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing	4
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines	4
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities	4
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines	4
Aims and Scope/Editorial Board/Publishing Details	4
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report	4
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities	3
Aims and Scope/Editorial Board/Publishing Details	3
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing	3
Evolution of FMT – From early clinical to standardized treatments	3
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era	3
Animal experiments show impact of vaccination on reduction of SARS-CoV-2 virus circulation: A model for vaccine development?	3
Aims and Scope/Editorial Board/Publishing Details	3
Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays	3
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2	3
Klebsiella pneumoniae vaccine studies in animal models	3
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report	3
Obituary - Inessa LEVENBOOK: 1926–2022	3
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation	3
Enabling the evaluation of COVID-19 vaccines with correlates of protection	3
Autogenous vaccines: Quality of production and movement in a common market	3
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 tools	2
Regulatory changes during the Covid-19 pandemic: A comparative review of the European Union and Brazilian regulations for biological and biotechnological products	2
Accelerated national lot release on COVID-19 vaccines in Republic of Korea	2
Development and evaluation of recombinant gD protein based ELISA for sero-surveillance of BoHV-1 in India	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 product	2
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response	2
Advances in mRNA vaccine research in the field of quality control	2
Aims and Scope/Editorial Board/Publishing Details	2
Aims and Scope/Editorial Board/Publishing Details	2
Development and optimization of multiplex PCR for rapid detection of type I-F1 and type I-F2 Cas cluster genes in Acinetobacter baumannii	2
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021	2
Viral clearance capability of monoclonal antibody purification	2
Immunization effect of lipopolysaccharide antigen in conjugation with PLGA nanoparticles as a nanovaccine against Brucella melitensis infection	2
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China	2
Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness	2
Expression and purification of Hepatitis B virus core antigen using Escherichia coli and its utilization for the diagnosis of Hepatitis B virus infections	2

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
An alternative In vitro method for evaluation of inactivated infectious bronchitis (IB) vaccines	2
Aims and Scope/Editorial Board/Publishing Details	2
Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure	2
Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses	2
An optimized microplate-based method to evaluate complement-dependent hemolysis mediated by intravenous immunoglobulins (IVIG)	2
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
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	2
The current status of the biosimilars landscape in China	2
A vision for patient-centric specifications for biologicals	2
Evaluation of DF-1 cell culture based vaccine development for infectious bursal disease virus in Ethiopia	2
Aims and Scope/Editorial Board/Publishing Details	2
A gaps-and-needs analysis of vaccine R&D in Europe: Recommendations to improve the research infrastructure	2
CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells	1
Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals	1
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 2021	1
Efficient extraction of adventitious virus nucleic acid using commercially available methods	1
A collaborative study to establish the second national standard for antithrombin concentrate in Korea	1
An indirect ELISA for detecting anti-SARS-CoV-2 antibodies in human sera using a baculovirus-expressed recombinant nucleocapsid antigen	1
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’ approach	1
Development and characterization of mouse monoclonal antibodies to canine morbillivirus	1
Development and validation of a spectrophotometric method for quantification of residual cyclodextrin (DIMEB; Heptakis) in pertussis antigens	1
It is time to reconsider the use of naturally-occurring endotoxins in endotoxin recovery studies: Part 2 of a BioPhorum harmonized endotoxin recovery study	1
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain	1
National Control Laboratories in quality healthcare-a roadblock for substandard biopharmaceuticals	1
Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean	1
Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & 5, 2021	1
Expression, purification, and immunogenicity study of human papillomavirus type 52 virus-like particles produced in Hansenula polymorpha	1
Corrigendum to “Comparison of Astra Zeneca and sinopharm vaccines as boosters in protection against COVID-19 infection” [Biologicals 82 (2023) 101668]	1
Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea	1
Virus filter scalability: Demonstration of consistent viral clearance across laboratory and manufacturing scales	1
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 data	1
Non-clinical similarity of biosimilar ABP 798 with rituximab reference product	1
Experimental cystic echinococcosis as a proof of concept for the development of peptide-based vaccines following a novel rational workflow	1
Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023	1
Aims and Scope/Editorial Board/Publishing Details	1
Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice	1
Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states	1
Emerging genetic diversity of SARS-CoV-2 RNA dependent RNA polymerase (RdRp) alters its B-cell epitopes	1
Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report	1
Emergence of SARS-CoV-2 variant of interest B.1.525 (Eta) in Bangladesh	1