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 2022-01-01 to 2026-01-01.)

Article	Citations
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops	24
Aims and Scope/Editorial Board/Publishing Details	23
EGF domain peptide of Developmentally regulated endothelial locus1 facilitates gene expression of extracellularly applied plasmid DNA	21
Conference report WHO informal consultation on the draft WHO Guideline on the phasing out of animal tests for the quality control of biological products	15
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA	14
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop	14
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency	13
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis	12
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model	12
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	11
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	10
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions	10
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report	10
Aims and Scope/Editorial Board/Publishing Details	10
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus	10
Vaccination and surveillance for high pathogenicity avian influenza in poultry—current situation and perspectives	9
Establishing potency and stability release specifications using alternative ATP assay of BCG Tokyo 172-1 vaccine used in Thailand	9
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines	9
Animal cell substrates for the production of biologicals: An introduction to WHO documents	9
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab	9
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics	9
Replacement of in vivo leptospirosis vaccine potency testing in the United States	8
IABS/DCVMN webinar on next generation sequencing	8
Report of the fourth conference on next-generation sequencing (NGS) for adventitious virus detection in biologics for humans and animals: Validation and implementation of NGS	8

Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine	7
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report	7
A new Japanese regulatory perspective regarding the indication extrapolation between approved intravenous immunoglobulins (IVIg) products based on comparability assessments of quality attributes	6
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report	6
Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y	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
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	5
A rapid and simple sterility test method based on solid culture medium containing blood	5
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
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing	4
Aims and Scope/Editorial Board/Publishing Details	4
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines	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	4
Aims and Scope/Editorial Board/Publishing Details	4
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients	4
Aims and Scope/Editorial Board/Publishing Details	4
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities	4
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report	4
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology	4
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines	4
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report	4
Glycoconjugate content quantification to assess vaccine potency: A simplified approach	4
Expression and purification of Hepatitis B virus core antigen using Escherichia coli and its utilization for the diagnosis of Hepatitis B virus infections	3
Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market integration	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
Evolution of FMT – From early clinical to standardized treatments	3
Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays	3
Autogenous vaccines: Quality of production and movement in a common market	3
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China	3
Aims and Scope/Editorial Board/Publishing Details	3
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era	3
Obituary - Inessa LEVENBOOK: 1926–2022	3
Klebsiella pneumoniae vaccine studies in animal models	3
The current status of the biosimilars landscape in China	3
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing	3
A meta-analysis to re-evaluate the sensitivity and specificity of FMDV NSP ELISA tests	3
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2	3
Enabling the evaluation of COVID-19 vaccines with correlates of protection	3
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	2
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response	2
Aims and Scope/Editorial Board/Publishing Details	2
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
Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states	2
A gaps-and-needs analysis of vaccine R&D in Europe: Recommendations to improve the research infrastructure	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
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
Evaluation of DF-1 cell culture based vaccine development for infectious bursal disease virus in Ethiopia	2
A vision for patient-centric specifications for biologicals	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
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021	2
Regulatory changes during the Covid-19 pandemic: A comparative review of the European Union and Brazilian regulations for biological and biotechnological products	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
Advances in mRNA vaccine research in the field of quality control	2
An alternative In vitro method for evaluation of inactivated infectious bronchitis (IB) vaccines	2
An optimized microplate-based method to evaluate complement-dependent hemolysis mediated by intravenous immunoglobulins (IVIG)	2
Evaluation of 1st WHO anti-malaria reference reagent for competition ELISA harmonisation and development of ADAMSEL analytical platform	2
Aims and Scope/Editorial Board/Publishing Details	2
Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness	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
Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea	2
Aims and Scope/Editorial Board/Publishing Details	2
An indirect ELISA for detecting anti-SARS-CoV-2 antibodies in human sera using a baculovirus-expressed recombinant nucleocapsid antigen	2
Corrigendum to “Vaccination and surveillance for high pathogenicity avian influenza in poultry-current situation and perspectives” [Biologicals 91 (2025) 101840]	2
Viral clearance capability of monoclonal antibody purification	2
Efficient extraction of adventitious virus nucleic acid using commercially available methods	1
Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean	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
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
National Control Laboratories in quality healthcare-a roadblock for substandard biopharmaceuticals	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
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
Emergence of SARS-CoV-2 variant of interest B.1.525 (Eta) in Bangladesh	1
Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023	1
A collaborative study to establish the second national standard for antithrombin concentrate in Korea	1
Expression, purification, and immunogenicity study of human papillomavirus type 52 virus-like particles produced in Hansenula polymorpha	1
Aims and Scope/Editorial Board/Publishing Details	1
Aims and Scope/Editorial Board/Publishing Details	1
Development and characterization of mouse monoclonal antibodies to canine morbillivirus	1
Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals	1
Functional characterization of the Clostridium perfringens quadruple point mutant epsilon toxin	1
Development and validation of a spectrophotometric method for quantification of residual cyclodextrin (DIMEB; Heptakis) in pertussis antigens	1
The pharmacokinetics and safety comparison of Zamerovimab and Mazorelvimab monoclonal antibodies vs. HRIG in category III rabies post-exposure prophylaxis: a stratified analysis by wound characteristi	1
Adjuvant Synergy: Alum and chlorogenic acid enhance Th1 responses and survival in a Salmonella typhimurium challenge model	1
Molecular characteristics of feline coronavirus in South Korea, 2016–2023	1
Corrigendum to “Effect of biomolecules derived from human platelet-rich plasma on the ex vivo expansion of human adipose-derived mesenchymal stem cells for clinical applications” [Biologicals 75 (2022	1
Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice	1
Corrigendum to “Comparison of Astra Zeneca and sinopharm vaccines as boosters in protection against COVID-19 infection” [Biologicals 82 (2023) 101668]	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
CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells	1
Experimental cystic echinococcosis as a proof of concept for the development of peptide-based vaccines following a novel rational workflow	1
Histological and functional exploration of platelet activity post-SARS-CoV-2 vaccination	1
A comprehensive review of current diagnostic techniques for Monkeypox virus detection	1