OOIR: Observatory of International Research

Papers

(The TQCC of Biologicals is 5. 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 2022-08-01 to 2026-08-01.)

Article	Citations
Aims and Scope/Editorial Board/Publishing Details	50
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop	35
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops	27
Conference report WHO informal consultation on the draft WHO Guideline on the phasing out of animal tests for the quality control of biological products	19
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA	16
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency	15
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques	15
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model	15
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis	15
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines	14
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab	13
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	13
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus	12
Animal cell substrates for the production of biologicals: An introduction to WHO documents	11
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report	11
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions	11
IABS/DCVMN webinar on next generation sequencing	11
Vaccination and surveillance for high pathogenicity avian influenza in poultry—current situation and perspectives	11
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
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics	9
Establishing potency and stability release specifications using alternative ATP assay of BCG Tokyo 172-1 vaccine used in Thailand	9
A rapid and simple sterility test method based on solid culture medium containing blood	8
Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine	8
Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus	8
A new Japanese regulatory perspective regarding the indication extrapolation between approved intravenous immunoglobulins (IVIg) products based on comparability assessments of quality attributes	8

Ethical approval for controlled human infectious model clinical trial protocols – A workshop report	8
Aims and Scope/Editorial Board/Publishing Details	8
Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y	8
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology	7
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients	7
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	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	7
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing	7
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines	6
Comment on “Preparation of poloxamer-based CPV virus-like particle vaccine and its immunological evaluation in mice”	6
Aims and Scope/Editorial Board/Publishing Details	6
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	5
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines	5
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation	5
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era	5
Aims and Scope/Editorial Board/Publishing Details	5
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities	5
Aims and Scope/Editorial Board/Publishing Details	5
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report	5
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report	5
A meta-analysis to re-evaluate the sensitivity and specificity of FMDV NSP ELISA tests	5