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 2020-03-01 to 2024-03-01.)

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	26
Towards rabies elimination in the Asia-Pacific region: From theory to practice	23
Virus disinfection for biotechnology applications: Different effectiveness on surface versus in suspension	19
Report of the second international conference on next generation sequencing for adventitious virus detection in biologics for humans and animals	18
Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report	16
A highly sensitive internally-controlled real-time PCR assay for mycoplasma detection in cell cultures	16
SARS-CoV-2: Virology, epidemiology, immunology and vaccine development	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	14
Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product	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
Novel application of adipose-derived mesenchymal stem cells via producing antiangiogenic factor TSP-1 in lung metastatic melanoma animal model	12
Report of the 2019 NIST-FDA workshop on standards for next generation sequencing detection of viral adventitious agents in biologics and biomanufacturing	11
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	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
Strategy and validation of a consistent and reproducible nucleic acid technique for mycoplasma detection in advanced therapy medicinal products	9
Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products	8
Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration	8
Recent progress and advances towards developing enterovirus 71 vaccines for effective protection against human hand, foot and mouth disease (HFMD)	8

IABS/CEPI platform technology webinar: Is it possible to reduce the vaccine development time?	8
Development and evaluation of polymeric nanoparticles as a delivery system for snake envenoming prevention	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
Protein decomplexation and proteomics: A complementary assessment method of the physicochemical purity of antivenom	7
Autogenous vaccines: Quality of production and movement in a common market	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
Induction of osteogenic differentiation by demineralized and decellularized bovine extracellular matrix derived hydrogels associated with barium titanate	6
Modulated mesenchymal stromal cells improve skin wound healing	6
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain	6
Evaluation of a standardised Vi poly-l-lysine ELISA for serology of Vi capsular polysaccharide antibodies	6
An investigation into gene copy number determination in transgenic yeast; The importance of selecting a reliable real-time PCR standard	6
Evaluation of adjuvant activity of Astragaloside VII and its combination with different immunostimulating agents in Newcastle Disease vaccine	6
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
Development of biotinylated polyclonal anti-ribonucleoprotein IgG for detection of rabies virus antigen by direct rapid immunohistochemical test	5
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization	5
A time-resolved fluoroimmunoassay for assessing rabies antibody titers in the sera of vaccinated human subjects	5
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients	5
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody	5
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression	5
Immunological cross-recognition and neutralization studies of Micrurus mipartitus and Micrurus dumerilii venoms by two therapeutic equine antivenoms	5
Obstacles to vaccination of animals and prospective solutions	4
Comparison of accompanying proteins in different therapeutic human serum albumin preparations	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
Comparability of biosimilar romiplostim with originator: Protein characterization, animal pharmacodynamics and pharmacokinetics	4
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report	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
Multiplex reverse transcriptase droplet digital PCR for the simultaneous quantification of four dengue serotypes: Proof of concept study	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
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
Decontamination efficacy of sodium hypochlorite solutions for poliovirus	3
Determination of the potency of a cell-based seasonal quadrivalent influenza vaccine using a purified primary liquid standard	3
Determination of the experimental extinction coefficient of therapeutic proteins using the Edelhoch method	3
Stability of live attenuated classical swine fever cell culture vaccine virus in liquid form for developing an oral vaccine	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
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
A gaps-and-needs analysis of vaccine R&D in Europe: Recommendations to improve the research infrastructure	3
Development and validation of a novel luciferase reporter gene assay to detect pyrogen	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
Glycoconjugation of Shigella flexneri type 2a O-polysaccharide with CRM197 as a potential vaccine candidate for shigellosis	3

Non-clinical similarity of biosimilar ABP 798 with rituximab reference product	3
An adventitious agent-free clonal cell line that is highly susceptible to foot -and-mouth disease virus	2
Comparison of AstraZeneca and sinopharm vaccines as boosters in protection against COVID-19 infection	2
Development of a visible loop mediated isothermal amplification assay for rapid detection of Bacillus anthracis	2
Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study	2
Transferability study of the BINACLE (binding and cleavage) assay for in vitro determination of botulinum neurotoxin activity	2
Virology, epidemiology, immunology and vaccine development of SARS-CoV-2, update after nine months of pandemic	2
A next-generation sequencing based method for determining genetic stability in Clostridium tetani vaccine strains	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 and characterization of mouse monoclonal antibodies to canine morbillivirus	2
Study on an attenuated rabies virus strain CTN181-3	2
Quantification of residual cetyltrimethylammonium bromide (CTAB) and sodium deoxycholate (DOC) in Haemophilus influenzae type b (Hib) polysaccharide using NMR	2
Development of IgM-ELISA for diagnosis of recent infection of Japanese encephalitis virus in equines	2
Klebsiella pneumoniae vaccine studies in animal models	2
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021	2
Evaluation of the immune response to a multi-epitope vaccine candidate in comparison with HlaH35L, MntC, and SACOL0723 proteins against MRSA infection	2
Infectivity assessment of porcine endogenous retrovirus using high-throughput sequencing technologies	2
Designing peptide-based vaccine candidates for Plasmodium falciparum erythrocyte binding antigen 175	2
Evolution of FMT – From early clinical to standardized treatments	2
A reliable assay for ensuring the biological activity of anti T lymphocyte immunoglobulin as an alternate to compendial flow cytometry method	2
Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & 5, 2021	2
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report	2
Metagenomic characterization of parental and production CHO cell lines for detection of adventitious viruses	2
Optimized dose of synthetic analogues of Monophosphoryl lipid A as an effective alternative for formulating recombinant human papillomavirus vaccine	2
Potency evaluation of rabies vaccine for human use: The impact of reducing the number of animals per dilution – Part 2	2
IABS/DCVMN webinar on next generation sequencing	2
Preliminary study on serum immunoglobulin G responses following intramuscular inoculation of adjuvanted polyhydroxyalkanoate microparticles with Pasteurella multocida vaccine in white rats	2
A real-time PCR assay based on a specific mutation of PstS1 gene for detection of M. bovis strains	2
CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells	1
Virus filter scalability: Demonstration of consistent viral clearance across laboratory and manufacturing scales	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
AS3288802, a highly selective antibody to active plasminogen activator inhibitor-1 (PAI-1), exhibits long efficacy duration in cynomolgus monkeys	1
Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China	1
Multiple antigenic peptide-based flow through dot-blot assay for simultaneous antibody detection of infectious bronchitis virus and Newcastle disease virus	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
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
Development of an optimized RT-LAMP test for the detection of SARS-CoV-2	1
Replacement of in vivo leptospirosis vaccine potency testing in the United States	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 second national standard for hepatitis B immunoglobulin in Korea	1
Acidic isoforms of Erwinase form part of the product: Correlation with clinical experience	1
Immunogenicity of fractional-dose of inactivated poliomyelitis vaccine made from Sabin strains delivered by intradermal vaccination in Wistar rats	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
ADCC enhancement: A conundrum or a boon to mAb therapy?	1
An overview of non-clinical safety studies in current Turkish regulations for the development of COVID-19 vaccines	1
Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019	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
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
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 history of adventitious agent contamination and the current methods to detect and remove them from pharmaceutical products	1
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
Accelerated national lot release on COVID-19 vaccines in Republic of Korea	1
Epidemiology-driven approaches to surveillance in HPAI-vaccinated poultry flocks aiming to demonstrate freedom from circulating HPAIV	1
Stability of lyophilized Meningococcal A conjugate vaccine, (MenAfriVac™) at elevated temperatures to support controlled temperature chain (CTC) claim	1
Cloning, expression and characterization of recombinant CagA protein of Helicobacter pylori using monoclonal antibodies: Its potential in diagnostics	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
A highly sensitive and robust LC-MS platform for host cell protein characterization in biotherapeutics	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
Quantitation of free cyanide using ion exchange chromatography in Neisseria meningitidis serogroups A, C, W, Y and X conjugates used in vaccine manufacture	1
Dose-sparing effect of Sabin-derived inactivated polio vaccine produced in Japan by intradermal injection device for rats	1
Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses	1