OOIR: Observatory of International Research

Papers

(The median citation count of Biologicals is 2. 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 2022-05-01 to 2026-05-01.)

Article	Citations
Aims and Scope/Editorial Board/Publishing Details	38
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop	28
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops	24
Conference report WHO informal consultation on the draft WHO Guideline on the phasing out of animal tests for the quality control of biological products	17
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model	15
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA	15
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis	14
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency	13
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	13
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques	13
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report	12
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions	11
Aims and Scope/Editorial Board/Publishing Details	11
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab	11
Vaccination and surveillance for high pathogenicity avian influenza in poultry—current situation and perspectives	10
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus	10
Animal cell substrates for the production of biologicals: An introduction to WHO documents	10
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines	10
IABS/DCVMN webinar on next generation sequencing	9
Replacement of in vivo leptospirosis vaccine potency testing in the United States	9
Establishing potency and stability release specifications using alternative ATP assay of BCG Tokyo 172-1 vaccine used in Thailand	9
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
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report	7
Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y	7
Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine	7

Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics	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	7
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	6
A rapid and simple sterility test method based on solid culture medium containing blood	6
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology	6
Aims and Scope/Editorial Board/Publishing Details	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	6
Aims and Scope/Editorial Board/Publishing Details	5
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines	5
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report	5
Aims and Scope/Editorial Board/Publishing Details	5
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines	5
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing	5
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients	5
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation	4
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era	4
Enabling the evaluation of COVID-19 vaccines with correlates of protection	4
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2	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
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing	4
A meta-analysis to re-evaluate the sensitivity and specificity of FMDV NSP ELISA tests	4
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report	4
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities	4
Obituary - Inessa LEVENBOOK: 1926–2022	4
The current status of the biosimilars landscape in China	3
A vision for patient-centric specifications for biologicals	3
Development and evaluation of recombinant gD protein based ELISA for sero-surveillance of BoHV-1 in India	3
Viral clearance capability of monoclonal antibody purification	3
Evaluation of DF-1 cell culture based vaccine development for infectious bursal disease virus in Ethiopia	3
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	3
Klebsiella pneumoniae vaccine studies in animal models	3
Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness	3
Evaluation of 1st WHO anti-malaria reference reagent for competition ELISA harmonisation and development of ADAMSEL analytical platform	3
Corrigendum to “Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean” [Biologicals 90 (2025) 101826]	3
An optimized microplate-based method to evaluate complement-dependent hemolysis mediated by intravenous immunoglobulins (IVIG)	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
Expression and purification of Hepatitis B virus core antigen using Escherichia coli and its utilization for the diagnosis of Hepatitis B virus infections	3
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China	3
Aims and Scope/Editorial Board/Publishing Details	3
Accelerated national lot release on COVID-19 vaccines in Republic of Korea	3
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response	3
Aims and Scope/Editorial Board/Publishing Details	3
Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market integration	3
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
Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses	2

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	2
Efficient extraction of adventitious virus nucleic acid using commercially available methods	2
Corrigendum to “Preparedness and response to emerging veterinary disease outbreaks – A meeting report” [Biologicals 93 (February 2026) 101873]	2
Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice	2
An alternative In vitro method for evaluation of inactivated infectious bronchitis (IB) vaccines	2
Regulatory changes during the Covid-19 pandemic: A comparative review of the European Union and Brazilian regulations for biological and biotechnological products	2
Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea	2
Optimization of a U937 cell-based reporter system to assess ADCC activity of ustekinumab versus trastuzumab	2
A collaborative study to establish the second national standard for antithrombin concentrate in Korea	2
Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean	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
An indirect ELISA for detecting anti-SARS-CoV-2 antibodies in human sera using a baculovirus-expressed recombinant nucleocapsid antigen	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
Corrigendum to “Vaccination and surveillance for high pathogenicity avian influenza in poultry-current situation and perspectives” [Biologicals 91 (2025) 101840]	2
Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure	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
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	2
Aims and Scope/Editorial Board/Publishing Details	2
Expression, purification, and immunogenicity study of human papillomavirus type 52 virus-like particles produced in Hansenula polymorpha	2
Aims and Scope/Editorial Board/Publishing Details	2