OOIR: Observatory of International Research

Papers

(The median citation count of Biologicals is 1. 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 2020-11-01 to 2024-11-01.)

Article	Citations
Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities	33
Next-generation vaccines and the impacts of state-of-the-art in-silico technologies	17
SARS-CoV-2 and the safety margins of cell-based biological medicinal products	17
Novel application of adipose-derived mesenchymal stem cells via producing antiangiogenic factor TSP-1 in lung metastatic melanoma animal model	16
Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product	15
Anti-CD20 monoclonal antibodies in Systemic Lupus Erythematosus	14
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals	14
Recent progress and advances towards developing enterovirus 71 vaccines for effective protection against human hand, foot and mouth disease (HFMD)	13
Establishment of a low-tumorigenic MDCK cell line and study of differential molecular networks	11
Autogenous vaccines: Quality of production and movement in a common market	10
Development and evaluation of polymeric nanoparticles as a delivery system for snake envenoming prevention	9
Emerging genetic diversity of SARS-CoV-2 RNA dependent RNA polymerase (RdRp) alters its B-cell epitopes	9
IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?	8
Critical aspects on traditional antivenom production processes and their optimization by factorial analysis	8
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	7
Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay	7
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody	7
Protein decomplexation and proteomics: A complementary assessment method of the physicochemical purity of antivenom	7
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression	7
Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS)	7
Evaluation of adjuvant activity of Astragaloside VII and its combination with different immunostimulating agents in Newcastle Disease vaccine	7
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	7
Determination of the experimental extinction coefficient of therapeutic proteins using the Edelhoch method	6
Characterisation of diphtheria monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay	6

Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain	6
A time-resolved fluoroimmunoassay for assessing rabies antibody titers in the sera of vaccinated human subjects	6
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	6
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients	6
Preparation, characterization, and pharmacological study of a novel long-acting FGF21 with a potential therapeutic effect in obesity	5
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response	5
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	5
Evolution of FMT – From early clinical to standardized treatments	5
Development of biotinylated polyclonal anti-ribonucleoprotein IgG for detection of rabies virus antigen by direct rapid immunohistochemical test	5
A highly sensitive and robust LC-MS platform for host cell protein characterization in biotherapeutics	5
Stability of live attenuated classical swine fever cell culture vaccine virus in liquid form for developing an oral vaccine	5
Immunological cross-recognition and neutralization studies of Micrurus mipartitus and Micrurus dumerilii venoms by two therapeutic equine antivenoms	5
Comparison of AstraZeneca and sinopharm vaccines as boosters in protection against COVID-19 infection	4
Glycoconjugate content quantification to assess vaccine potency: A simplified approach	4
Glycoconjugation of Shigella flexneri type 2a O-polysaccharide with CRM197 as a potential vaccine candidate for shigellosis	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
An adventitious agent-free clonal cell line that is highly susceptible to foot -and-mouth disease virus	4
Metagenomic characterization of parental and production CHO cell lines for detection of adventitious viruses	4
Determination of the potency of a cell-based seasonal quadrivalent influenza vaccine using a purified primary liquid standard	4
Immunization effect of lipopolysaccharide antigen in conjugation with PLGA nanoparticles as a nanovaccine against Brucella melitensis infection	4
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of vaccines and biological therapeutics manufacturers	4
Klebsiella pneumoniae vaccine studies in animal models	4
Epidemiology-driven approaches to surveillance in HPAI-vaccinated poultry flocks aiming to demonstrate freedom from circulating HPAIV	3
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing	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
Development and validation of a novel luciferase reporter gene assay to detect pyrogen	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
Tumorigenesis mechanism and application strategy of the MDCK cell line: A systematic review	3
Novel phage display-derived recombinant antibodies recognizing both MPT64 native and mutant (63-bp deletion) are promising tools for tuberculosis diagnosis	3
Non-clinical similarity of biosimilar ABP 798 with rituximab reference product	3
Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals	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
Animal experiments show impact of vaccination on reduction of SARS-CoV-2 virus circulation: A model for vaccine development?	3
ADCC enhancement: A conundrum or a boon to mAb therapy?	3
Optimized dose of synthetic analogues of Monophosphoryl lipid A as an effective alternative for formulating recombinant human papillomavirus vaccine	3
Experimental cystic echinococcosis as a proof of concept for the development of peptide-based vaccines following a novel rational workflow	3
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021	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
Saccharide dosage content of meningococcal polysaccharide conjugate vaccines determined using WHO International Standards for serogroup A, C, W, Y and X polysaccharides	3
A collaborative study to establish the second national standard for hepatitis B immunoglobulin in Korea	2
Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023	2
Preliminary study on serum immunoglobulin G responses following intramuscular inoculation of adjuvanted polyhydroxyalkanoate microparticles with Pasteurella multocida vaccine in white rats	2
Quantification of residual cetyltrimethylammonium bromide (CTAB) and sodium deoxycholate (DOC) in Haemophilus influenzae type b (Hib) polysaccharide using NMR	2
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China	2
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	2
Stable, high yield expression of gp145 Env glycoprotein from HIV-1 in mammalian cells	2
The contribution of field efficacy studies to the evaluation of applications for veterinary vaccines evaluated through the European Union centralised authorisation procedure	2
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2	2

The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report	2
Study on an attenuated rabies virus strain CTN181-3	2
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop	2
Development of a visible loop mediated isothermal amplification assay for rapid detection of Bacillus anthracis	2
Metabolic reprogramming and alteration of the redox state in hyper-productive MDCK cells for influenza a virus production	2
Evaluation of the immune response to a multi-epitope vaccine candidate in comparison with HlaH35L, MntC, and SACOL0723 proteins against MRSA infection	2
Quantitation of free cyanide using ion exchange chromatography in Neisseria meningitidis serogroups A, C, W, Y and X conjugates used in vaccine manufacture	2
IABS/DCVMN webinar on next generation sequencing	2
Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses	2
Virus filter scalability: Demonstration of consistent viral clearance across laboratory and manufacturing scales	2
Development and characterization of mouse monoclonal antibodies to canine morbillivirus	2
Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & 5, 2021	2
Development of a droplet digital PCR for pertussis toxin locus copy number determination in a genetically-modified Bordetella pertussis strain	2
Molecular characterization and sequecing analysis of SARS-CoV-2 genome in Minas Gerais, Brazil	2
Virology, epidemiology, immunology and vaccine development of SARS-CoV-2, update after nine months of pandemic	2
Infectivity assessment of porcine endogenous retrovirus using high-throughput sequencing technologies	2
Development of IgM-ELISA for diagnosis of recent infection of Japanese encephalitis virus in equines	2
Detection of hepatitis C virus and parvovirus B19 in human plasma pools by nucleic-acid amplification techniques – Trends in results of EDQM proficiency testing studies from 2004 to 2018	1
Considerations on chemistry, manufacturing, and control of stem cell products for Investigational New Drug application in China	1
On-column virus inactivation by solvent/detergent treatment for a recombinant biological product	1
A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency	1
Stability of lyophilized Meningococcal A conjugate vaccine, (MenAfriVac™) at elevated temperatures to support controlled temperature chain (CTC) claim	1
An ELISA system for tetanus toxoid potency tests: An alternative to lethal challenge	1
Comparison of skeletal muscle decellularization protocols and recellularization with adipose-derived stem cells for tissue engineering	1
Cross-protective efficacy of immuno-stimulatory recombinant Brugia malayi protein HSP60 against the Leishmania donovani in BALB/c mice	1
Confirming the absence of parental African swine fever virus as a potential contaminant of recombinant live attenuated ASF vaccines	1
A collaborative study to establish the national standard for SARS-CoV-2 RNA nucleic acid amplification techniques (NAAT) in Taiwan	1
Development of a new, simple, rapid ultra-high-performance liquid chromatography (UHPLC) method for the quantification of 2-phenoxyethanol in vaccines for human use	1
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	1
Immunogenicity of fractional-dose of inactivated poliomyelitis vaccine made from Sabin strains delivered by intradermal vaccination in Wistar rats	1
Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model	1
An overview of non-clinical safety studies in current Turkish regulations for the development of COVID-19 vaccines	1
Cloning, expression and characterization of recombinant CagA protein of Helicobacter pylori using monoclonal antibodies: Its potential in diagnostics	1
Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states	1
Antivenoms, hepatitis B vaccine and oral polio vaccine can be considered for storage and handling outside the cold chain following the innovative ‘controlled temperature chain’ approach	1
Dose-sparing effect of Sabin-derived inactivated polio vaccine produced in Japan by intradermal injection device for rats	1
National Control Laboratories in quality healthcare-a roadblock for substandard biopharmaceuticals	1
Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure	1
CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells	1
Accelerated national lot release on COVID-19 vaccines in Republic of Korea	1
Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines	1
Multiple antigenic peptide-based flow through dot-blot assay for simultaneous antibody detection of infectious bronchitis virus and Newcastle disease virus	1
Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019	1
Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice	1
Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023	1
A history of adventitious agent contamination and the current methods to detect and remove them from pharmaceutical products	1