Biologicals

Papers
(The TQCC of Biologicals is 4. 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 2022-06-01 to 2026-06-01.)
ArticleCitations
Aims and Scope/Editorial Board/Publishing Details41
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops30
Conference report WHO informal consultation on the draft WHO Guideline on the phasing out of animal tests for the quality control of biological products24
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop17
Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis15
Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA15
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model15
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report13
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency13
The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques13
Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions12
Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report12
Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab11
Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines11
A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus11
Aims and Scope/Editorial Board/Publishing Details11
Animal cell substrates for the production of biologicals: An introduction to WHO documents10
Vaccination and surveillance for high pathogenicity avian influenza in poultry—current situation and perspectives10
Replacement of in vivo leptospirosis vaccine potency testing in the United States9
Establishing potency and stability release specifications using alternative ATP assay of BCG Tokyo 172-1 vaccine used in Thailand9
IABS/DCVMN webinar on next generation sequencing9
Report of the fourth conference on next-generation sequencing (NGS) for adventitious virus detection in biologics for humans and animals: Validation and implementation of NGS8
Ethical approval for controlled human infectious model clinical trial protocols – A workshop report8
A rapid and simple sterility test method based on solid culture medium containing blood7
Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y7
A new Japanese regulatory perspective regarding the indication extrapolation between approved intravenous immunoglobulins (IVIg) products based on comparability assessments of quality attributes7
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report7
Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics7
Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine7
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 virus6
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines6
Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing6
Aims and Scope/Editorial Board/Publishing Details6
Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology6
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients6
Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus6
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 approach6
Aims and Scope/Editorial Board/Publishing Details6
Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines5
Aims and Scope/Editorial Board/Publishing Details5
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities5
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report5
From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era4
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities4
Obituary - Inessa LEVENBOOK: 1926–20224
Aims and Scope/Editorial Board/Publishing Details4
Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation4
Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market integration4
Development of an optimized RT-LAMP test for the detection of SARS-CoV-24
The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report4
A meta-analysis to re-evaluate the sensitivity and specificity of FMDV NSP ELISA tests4
Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays4
Enabling the evaluation of COVID-19 vaccines with correlates of protection4
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