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 2020-04-01 to 2024-04-01.)

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	28
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
Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products	8
Development and evaluation of polymeric nanoparticles as a delivery system for snake envenoming prevention	8
IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?	8
An investigation into gene copy number determination in transgenic yeast; The importance of selecting a reliable real-time PCR standard	7
Protein decomplexation and proteomics: A complementary assessment method of the physicochemical purity of antivenom	7
The potential markers of NK-92 associated to cytotoxicity against K562 cells	7
Critical aspects on traditional antivenom production processes and their optimization by factorial analysis	7

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
Evaluation of a standardised Vi poly-l-lysine ELISA for serology of Vi capsular polysaccharide antibodies	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
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report	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
Development of biotinylated polyclonal anti-ribonucleoprotein IgG for detection of rabies virus antigen by direct rapid immunohistochemical test	5
Immunological cross-recognition and neutralization studies of Micrurus mipartitus and Micrurus dumerilii venoms by two therapeutic equine antivenoms	5
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody	5
A time-resolved fluoroimmunoassay for assessing rabies antibody titers in the sera of vaccinated human subjects	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
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients	5
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	5
Comparability of biosimilar romiplostim with originator: Protein characterization, animal pharmacodynamics and pharmacokinetics	4
Multiplex reverse transcriptase droplet digital PCR for the simultaneous quantification of four dengue serotypes: Proof of concept study	4
Comparison of three immunoassays for infliximab trough level monitoring in paediatric inflammatory bowel diseases	4
Glycoconjugate content quantification to assess vaccine potency: A simplified approach	4
Obstacles to vaccination of animals and prospective solutions	4
Determination of the experimental extinction coefficient of therapeutic proteins using the Edelhoch method	4
Another case of mistaken identity? Vaccinia virus in another live Camelpox vaccine	4
Processing bovine intestinal mucosa to active heparin removes spiked BSE agent	4
Characterisation of diphtheria monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay	4
Immunization effect of lipopolysaccharide antigen in conjugation with PLGA nanoparticles as a nanovaccine against Brucella melitensis infection	4
Decontamination efficacy of sodium hypochlorite solutions for poliovirus	3
Non-clinical similarity of biosimilar ABP 798 with rituximab reference product	3
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	3
Stability of live attenuated classical swine fever cell culture vaccine virus in liquid form for developing an oral vaccine	3
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response	3
Saccharide dosage content of meningococcal polysaccharide conjugate vaccines determined using WHO International Standards for serogroup A, C, W, Y and X polysaccharides	3
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
Comparison of AstraZeneca and sinopharm vaccines as boosters in protection against COVID-19 infection	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
Designing peptide-based vaccine candidates for Plasmodium falciparum erythrocyte binding antigen 175	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
A gaps-and-needs analysis of vaccine R&D in Europe: Recommendations to improve the research infrastructure	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
Development and validation of a novel luciferase reporter gene assay to detect pyrogen	3
Animal experiments show impact of vaccination on reduction of SARS-CoV-2 virus circulation: A model for vaccine development?	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
Transferability study of the BINACLE (binding and cleavage) assay for in vitro determination of botulinum neurotoxin activity	2
Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & 5, 2021	2

Virology, epidemiology, immunology and vaccine development of SARS-CoV-2, update after nine months of pandemic	2
Klebsiella pneumoniae vaccine studies in animal models	2
The contribution of field efficacy studies to the evaluation of applications for veterinary vaccines evaluated through the European Union centralised authorisation procedure	2
Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study	2
Potency evaluation of rabies vaccine for human use: The impact of reducing the number of animals per dilution – Part 2	2
An adventitious agent-free clonal cell line that is highly susceptible to foot -and-mouth disease virus	2
Evaluation of the immune response to a multi-epitope vaccine candidate in comparison with HlaH35L, MntC, and SACOL0723 proteins against MRSA infection	2
Development of a visible loop mediated isothermal amplification assay for rapid detection of Bacillus anthracis	2
IABS/DCVMN webinar on next generation sequencing	2
Development of IgM-ELISA for diagnosis of recent infection of Japanese encephalitis virus in equines	2
A reliable assay for ensuring the biological activity of anti T lymphocyte immunoglobulin as an alternate to compendial flow cytometry method	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
Optimized dose of synthetic analogues of Monophosphoryl lipid A as an effective alternative for formulating recombinant human papillomavirus vaccine	2
Metagenomic characterization of parental and production CHO cell lines for detection of adventitious viruses	2
Infectivity assessment of porcine endogenous retrovirus using high-throughput sequencing technologies	2
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021	2
Study on an attenuated rabies virus strain CTN181-3	2
Development and characterization of mouse monoclonal antibodies to canine morbillivirus	2
On-column virus inactivation by solvent/detergent treatment for a recombinant biological product	1
Considerations on chemistry, manufacturing, and control of stem cell products for Investigational New Drug application in China	1
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China	1
Immunogenicity of fractional-dose of inactivated poliomyelitis vaccine made from Sabin strains delivered by intradermal vaccination in Wistar rats	1
Cloning, expression and characterization of recombinant CagA protein of Helicobacter pylori using monoclonal antibodies: Its potential in diagnostics	1
Stability of lyophilized Meningococcal A conjugate vaccine, (MenAfriVac™) at elevated temperatures to support controlled temperature chain (CTC) claim	1
A highly sensitive and robust LC-MS platform for host cell protein characterization in biotherapeutics	1
WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25–26 June 2019	1
Stable, high yield expression of gp145 Env glycoprotein from HIV-1 in mammalian cells	1
Comparability studies of hemin from two different origins porcine and bovine in the production of Haemophilus influenzae type b (Hib) polysaccharide	1
National Control Laboratories in quality healthcare-a roadblock for substandard biopharmaceuticals	1
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2	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
A collaborative study to establish the second national standard for hepatitis B immunoglobulin in Korea	1
Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses	1
Expression and purification of Hepatitis B virus core antigen using Escherichia coli and its utilization for the diagnosis of Hepatitis B virus infections	1
Virus filter scalability: Demonstration of consistent viral clearance across laboratory and manufacturing scales	1
ADCC enhancement: A conundrum or a boon to mAb therapy?	1
AS3288802, a highly selective antibody to active plasminogen activator inhibitor-1 (PAI-1), exhibits long efficacy duration in cynomolgus monkeys	1
High-Throughput Sequencing (HTS) of newly synthetized RNAs enables one shot detection and identification of live mycoplasmas and differentiation from inert nucleic acids	1
Multiple antigenic peptide-based flow through dot-blot assay for simultaneous antibody detection of infectious bronchitis virus and Newcastle disease virus	1
Cross-protective efficacy of immuno-stimulatory recombinant Brugia malayi protein HSP60 against the Leishmania donovani in BALB/c mice	1
Effect of change in cell substrate on the critical quality attributes of L-Zagreb Mumps vaccine manufactured using parallel plate bioreactor	1
Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing	1
A collaborative study to establish the national standard for SARS-CoV-2 RNA nucleic acid amplification techniques (NAAT) in Taiwan	1
Quantitation of free cyanide using ion exchange chromatography in Neisseria meningitidis serogroups A, C, W, Y and X conjugates used in vaccine manufacture	1
Confirming the absence of parental African swine fever virus as a potential contaminant of recombinant live attenuated ASF vaccines	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
CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells	1
Epidemiology-driven approaches to surveillance in HPAI-vaccinated poultry flocks aiming to demonstrate freedom from circulating HPAIV	1
Accelerated national lot release on COVID-19 vaccines in Republic of Korea	1
Development of a droplet digital PCR for pertussis toxin locus copy number determination in a genetically-modified Bordetella pertussis strain	1
Rationale for supporting stepwise access to safe plasma proteins through local production in low- and middle-income countries: A commentary of an international workshop	1
Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019	1
An overview of non-clinical safety studies in current Turkish regulations for the development of COVID-19 vaccines	1
Metabolic reprogramming and alteration of the redox state in hyper-productive MDCK cells for influenza a virus production	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
Replacement of in vivo leptospirosis vaccine potency testing in the United States	1
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
Dose-sparing effect of Sabin-derived inactivated polio vaccine produced in Japan by intradermal injection device for rats	1
A history of adventitious agent contamination and the current methods to detect and remove them from pharmaceutical products	1