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 2020-05-01 to 2024-05-01.)

Article	Citations
The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019	34
Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities	29
Report of the second international conference on next generation sequencing for adventitious virus detection in biologics for humans and animals	18
SARS-CoV-2: Virology, epidemiology, immunology and vaccine development	17
Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report	16
Next-generation vaccines and the impacts of state-of-the-art in-silico technologies	15
SARS-CoV-2 and the safety margins of cell-based biological medicinal products	15
Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product	14
Novel application of adipose-derived mesenchymal stem cells via producing antiangiogenic factor TSP-1 in lung metastatic melanoma animal model	14
Anti-CD20 monoclonal antibodies in Systemic Lupus Erythematosus	13
SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues	12
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals	11
Establishment of a low-tumorigenic MDCK cell line and study of differential molecular networks	10
Recent progress and advances towards developing enterovirus 71 vaccines for effective protection against human hand, foot and mouth disease (HFMD)	9
Comparison of bacterial endotoxin testing methods in purified pharmaceutical water matrices	9
Emerging genetic diversity of SARS-CoV-2 RNA dependent RNA polymerase (RdRp) alters its B-cell epitopes	9
Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019	9
A cross-industry forum on benchmarking critical quality attribute identification and linkage to process characterization studies	9
Development and evaluation of polymeric nanoparticles as a delivery system for snake envenoming prevention	8
Critical aspects on traditional antivenom production processes and their optimization by factorial analysis	8
Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products	8
IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?	8
Protein decomplexation and proteomics: A complementary assessment method of the physicochemical purity of antivenom	7
An investigation into gene copy number determination in transgenic yeast; The importance of selecting a reliable real-time PCR standard	7
The potential markers of NK-92 associated to cytotoxicity against K562 cells	7

Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report	6
Induction of osteogenic differentiation by demineralized and decellularized bovine extracellular matrix derived hydrogels associated with barium titanate	6
Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay	6
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	6
Evaluation of a standardised Vi poly-l-lysine ELISA for serology of Vi capsular polysaccharide antibodies	6
Modulated mesenchymal stromal cells improve skin wound healing	6
Evaluation of adjuvant activity of Astragaloside VII and its combination with different immunostimulating agents in Newcastle Disease vaccine	6
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients	6
Autogenous vaccines: Quality of production and movement in a common market	6
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain	6
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression	6
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	5
Determination of the experimental extinction coefficient of therapeutic proteins using the Edelhoch method	5
Development of biotinylated polyclonal anti-ribonucleoprotein IgG for detection of rabies virus antigen by direct rapid immunohistochemical test	5
Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS)	5
Preparation, characterization, and pharmacological study of a novel long-acting FGF21 with a potential therapeutic effect in obesity	5
A time-resolved fluoroimmunoassay for assessing rabies antibody titers in the sera of vaccinated human subjects	5
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody	5
Processing bovine intestinal mucosa to active heparin removes spiked BSE agent	5
Characterisation of diphtheria monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay	5
Immunological cross-recognition and neutralization studies of Micrurus mipartitus and Micrurus dumerilii venoms by two therapeutic equine antivenoms	5
Multiplex reverse transcriptase droplet digital PCR for the simultaneous quantification of four dengue serotypes: Proof of concept study	4
Another case of mistaken identity? Vaccinia virus in another live Camelpox vaccine	4
Glycoconjugate content quantification to assess vaccine potency: A simplified approach	4
Obstacles to vaccination of animals and prospective solutions	4
Stability of live attenuated classical swine fever cell culture vaccine virus in liquid form for developing an oral vaccine	4
Immunization effect of lipopolysaccharide antigen in conjugation with PLGA nanoparticles as a nanovaccine against Brucella melitensis infection	4
Comparability of biosimilar romiplostim with originator: Protein characterization, animal pharmacodynamics and pharmacokinetics	4
Comparison of three immunoassays for infliximab trough level monitoring in paediatric inflammatory bowel diseases	4
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response	4
Novel phage display-derived recombinant antibodies recognizing both MPT64 native and mutant (63-bp deletion) are promising tools for tuberculosis diagnosis	3
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of vaccines and biological therapeutics manufacturers	3
Evolution of FMT – From early clinical to standardized treatments	3
Development and validation of a novel luciferase reporter gene assay to detect pyrogen	3
Development of a rabbit monocyte activation test as an alternative to the rabbit pyrogen test and its application in the analysis of plasma-derived products	3
Summary of the WHO hearing on the development of product-specific reference materials for coagulation factor VIII and factor IX products	3
A practical approach for gmp-compliant validation of real-time PCR method for mycoplasma detection in human mesenchymal stromal cells as advanced therapy medicinal product	3
Glycoconjugation of Shigella flexneri type 2a O-polysaccharide with CRM197 as a potential vaccine candidate for shigellosis	3
Determination of the potency of a cell-based seasonal quadrivalent influenza vaccine using a purified primary liquid standard	3
Non-clinical similarity of biosimilar ABP 798 with rituximab reference product	3
Comparison of AstraZeneca and sinopharm vaccines as boosters in protection against COVID-19 infection	3
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	3
Saccharide dosage content of meningococcal polysaccharide conjugate vaccines determined using WHO International Standards for serogroup A, C, W, Y and X polysaccharides	3
Decontamination efficacy of sodium hypochlorite solutions for poliovirus	3
A gaps-and-needs analysis of vaccine R&D in Europe: Recommendations to improve the research infrastructure	3
Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study	3
Modeling the long-term 2-8 °C stability profiles of a live, rotavirus vaccine candidate (RV3-BB) in various liquid formulations via extrapolations of real-time and accelerated stability data	3
Animal experiments show impact of vaccination on reduction of SARS-CoV-2 virus circulation: A model for vaccine development?	3
Designing peptide-based vaccine candidates for Plasmodium falciparum erythrocyte binding antigen 175	3