OOIR: Observatory of International Research

Papers

(The TQCC of Biologicals is 3. 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 2021-12-01 to 2025-12-01.)

Article	Citations
Conference report WHO informal consultation on the draft WHO Guideline on the phasing out of animal tests for the quality control of biological products	23
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops	21
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	14
EGF domain peptide of Developmentally regulated endothelial locus1 facilitates gene expression of extracellularly applied plasmid DNA	14
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA	13
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency	13
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model	12
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis	11
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression	10
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report	10
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus	10
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines	10
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques	10
Aims and Scope/Editorial Board/Publishing Details	10
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	9
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab	9
Animal cell substrates for the production of biologicals: An introduction to WHO documents	9
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions	9
Vaccination and surveillance for high pathogenicity avian influenza in poultry—current situation and perspectives	9
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	9
Replacement of in vivo leptospirosis vaccine potency testing in the United States	8
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics	8
IABS/DCVMN webinar on next generation sequencing	7
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report	7

Establishing potency and stability release specifications using alternative ATP assay of BCG Tokyo 172-1 vaccine used in Thailand	7
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
A new Japanese regulatory perspective regarding the indication extrapolation between approved intravenous immunoglobulins (IVIg) products based on comparability assessments of quality attributes	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	5
Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus	5
Aims and Scope/Editorial Board/Publishing Details	4
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing	4
Aims and Scope/Editorial Board/Publishing Details	4
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines	4
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	4
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology	4
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines	4
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report	4
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	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
Obituary - Inessa LEVENBOOK: 1926–2022	3
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report	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
Enabling the evaluation of COVID-19 vaccines with correlates of protection	3
Klebsiella pneumoniae vaccine studies in animal models	3
Glycoconjugate content quantification to assess vaccine potency: A simplified approach	3
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era	3
A meta-analysis to re-evaluate the sensitivity and specificity of FMDV NSP ELISA tests	3
Evolution of FMT – From early clinical to standardized treatments	3
Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market integration	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
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
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation	3
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing	3
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2	3
Autogenous vaccines: Quality of production and movement in a common market	3