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 2021-11-01 to 2025-11-01.)

Article	Citations
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops	25
Aims and Scope/Editorial Board/Publishing Details	23
EGF domain peptide of Developmentally regulated endothelial locus1 facilitates gene expression of extracellularly applied plasmid DNA	20
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
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
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
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
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression	11
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines	10
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions	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
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report	10
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	9
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus	9
Animal cell substrates for the production of biologicals: An introduction to WHO documents	9
Aims and Scope/Editorial Board/Publishing Details	9
Vaccination and surveillance for high pathogenicity avian influenza in poultry—current situation and perspectives	9
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab	9
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
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics	8
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report	8
Replacement of in vivo leptospirosis vaccine potency testing in the United States	8

Establishing potency and stability release specifications using alternative ATP assay of BCG Tokyo 172-1 vaccine used in Thailand	8
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals	7
A rapid and simple sterility test method based on solid culture medium containing blood	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
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report	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
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody	5
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology	5
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
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing	4
Aims and Scope/Editorial Board/Publishing Details	4
Aims and Scope/Editorial Board/Publishing Details	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
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities	4
Aims and Scope/Editorial Board/Publishing Details	4
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines	4
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines	4
Glycoconjugate content quantification to assess vaccine potency: A simplified approach	3
Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays	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
Obituary - Inessa LEVENBOOK: 1926–2022	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
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era	3
Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market integration	3
Aims and Scope/Editorial Board/Publishing Details	3
A meta-analysis to re-evaluate the sensitivity and specificity of FMDV NSP ELISA tests	3
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report	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
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