Biologicals

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 2020-11-01 to 2024-11-01.)
ArticleCitations
Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities33
Next-generation vaccines and the impacts of state-of-the-art in-silico technologies17
SARS-CoV-2 and the safety margins of cell-based biological medicinal products17
Novel application of adipose-derived mesenchymal stem cells via producing antiangiogenic factor TSP-1 in lung metastatic melanoma animal model16
Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product15
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals14
Anti-CD20 monoclonal antibodies in Systemic Lupus Erythematosus14
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 networks11
Autogenous vaccines: Quality of production and movement in a common market10
Development and evaluation of polymeric nanoparticles as a delivery system for snake envenoming prevention9
Emerging genetic diversity of SARS-CoV-2 RNA dependent RNA polymerase (RdRp) alters its B-cell epitopes9
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 analysis8
The potential markers of NK-92 associated to cytotoxicity against K562 cells7
Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report7
Characterisation of tetanus monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay7
Development and comparison of three cell-based potency assays for anti-respiratory syncytial virus monoclonal antibody7
Protein decomplexation and proteomics: A complementary assessment method of the physicochemical purity of antivenom7
Potential therapeutic effects of hAMSCs secretome on Panc1 pancreatic cancer cells through downregulation of SgK269, E-cadherin, vimentin, and snail expression7
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 vaccine7
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization7
Determination of the experimental extinction coefficient of therapeutic proteins using the Edelhoch method6
Characterisation of diphtheria monoclonal antibodies as a first step towards the development of an in vitro vaccine potency immunoassay6
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain6
A time-resolved fluoroimmunoassay for assessing rabies antibody titers in the sera of vaccinated human subjects6
The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report6
Expression profiling of inflammation-related genes including IFI-16, NOTCH2, CXCL8, THBS1 in COVID-19 patients6
Preparation, characterization, and pharmacological study of a novel long-acting FGF21 with a potential therapeutic effect in obesity5
Adjuvant effect of mesoporous silica SBA-15 on anti-diphtheria and anti-tetanus humoral immune response5
Similarity demonstrated between isolated charge variants of MB02, a biosimilar of bevacizumab, and Avastin® following extended physicochemical and functional characterization5
Evolution of FMT – From early clinical to standardized treatments5
Development of biotinylated polyclonal anti-ribonucleoprotein IgG for detection of rabies virus antigen by direct rapid immunohistochemical test5
A highly sensitive and robust LC-MS platform for host cell protein characterization in biotherapeutics5
Stability of live attenuated classical swine fever cell culture vaccine virus in liquid form for developing an oral vaccine5
Immunological cross-recognition and neutralization studies of Micrurus mipartitus and Micrurus dumerilii venoms by two therapeutic equine antivenoms5
Glycoconjugation of Shigella flexneri type 2a O-polysaccharide with CRM197 as a potential vaccine candidate for shigellosis4
Comparability of biosimilar romiplostim with originator: Protein characterization, animal pharmacodynamics and pharmacokinetics4
Comparison of three immunoassays for infliximab trough level monitoring in paediatric inflammatory bowel diseases4
An adventitious agent-free clonal cell line that is highly susceptible to foot -and-mouth disease virus4
Metagenomic characterization of parental and production CHO cell lines for detection of adventitious viruses4
Determination of the potency of a cell-based seasonal quadrivalent influenza vaccine using a purified primary liquid standard4
Immunization effect of lipopolysaccharide antigen in conjugation with PLGA nanoparticles as a nanovaccine against Brucella melitensis infection4
Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of vaccines and biological therapeutics manufacturers4
Klebsiella pneumoniae vaccine studies in animal models4
Comparison of AstraZeneca and sinopharm vaccines as boosters in protection against COVID-19 infection4
Glycoconjugate content quantification to assess vaccine potency: A simplified approach4
Epidemiology-driven approaches to surveillance in HPAI-vaccinated poultry flocks aiming to demonstrate freedom from circulating HPAIV3
Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing3
A gaps-and-needs analysis of vaccine R&D in Europe: Recommendations to improve the research infrastructure3
Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study3
Development and validation of a novel luciferase reporter gene assay to detect pyrogen3
A practical approach for gmp-compliant validation of real-time PCR method for mycoplasma detection in human mesenchymal stromal cells as advanced therapy medicinal product3
Tumorigenesis mechanism and application strategy of the MDCK cell line: A systematic review3
Novel phage display-derived recombinant antibodies recognizing both MPT64 native and mutant (63-bp deletion) are promising tools for tuberculosis diagnosis3
Non-clinical similarity of biosimilar ABP 798 with rituximab reference product3
Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals3
Development of a rabbit monocyte activation test as an alternative to the rabbit pyrogen test and its application in the analysis of plasma-derived products3
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 vaccine3
Experimental cystic echinococcosis as a proof of concept for the development of peptide-based vaccines following a novel rational workflow3
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 20213
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 data3
Saccharide dosage content of meningococcal polysaccharide conjugate vaccines determined using WHO International Standards for serogroup A, C, W, Y and X polysaccharides3
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