Explore chapters and articles related to this topic
Analytics and virus production processes
Published in Amine Kamen, Laura Cervera, Bioprocessing of Viral Vaccines, 2023
To start with definitions, biological activity is a critical quality attribute (CQA), which means that biological activity is qualifying the viral product in terms of efficiency. Different types of assays are applied to evaluate the biological activity of virus production. Most of the assays are biochemical or cell-culture-based assays. Molecular biology assays were extensively developed in the last twenty years to identify more effectively viral variants and strains. Viral potency is the quantitative measurement of the biological activity of a viral product. Thus, the potency of a viral product refers to the comprehension of the relation between the product activity and its biological quantity. As an example, a potency assay could be quantifying the amount of protein needed to give a specific activity of a vaccine, such as protection of a patient. The viral potency is thus dependent on the targeted molecule's affinity and its efficacy. For vaccines, the main target is to evaluate the product immunogenicity. In such cases, the quantification techniques aim to describe the amount of antigen (or antigen epitopes) which are necessary for the onset of an immune response in-vivo, either on animals or in human patients. The protective effect of such induced immune response is then further evaluated. The immune response quality will be evaluated by the specific quantification of both B-cell humoral and specific antibodies release or T-cell cytotoxic response to protect against the infectious disease.
Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device and Diagnostic Industries
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
As with all methods, other considerations included in the USP and ICH standards for methods validation should be observed, including: System suitability.Standards or controls to ensure that the assay is valid.Robustness to demonstrate that the assay is suitable under a potential known variability of the assay method and its parameters.Control over those materials and supplies, the consumable products that are used with the performance of the assay (e.g., for HPLC—column manufacturer, mobile phase solvent grades, water quality, sample filters).
Sensor Systems for Label-Free Detection of Biomolecular Interactions: Quartz Crystal Microbalance (QCM) and Surface Plasmon Resonance (SPR)
Published in Yallup Kevin, Basiricò Laura, Iniewski Kris, Sensors for Diagnostics and Monitoring, 2018
Şükran Şeker, M. Taner Vurat, Arin Doğan, A. Eser Elçin, Y. Murat Elçin
Commonly used assays in pharmaceutical screening or diagnostics usually involve labeling steps such as fluorescent, radioactive, chemiluminescent, or enzymatic labeling. This labeling indicates the interaction between the ligand and its receptor. It is a costly and a time-consuming process. Additionally, the label or secondary reagents used in some assays can interfere with the biomolecular interactions by blocking the binding site or causing steric hindrance. These challenges severely affect the detection method and may lead to false positive or false negative signals [2]. As per these unfavorable examples, the label-free technologies have gained importance in the recent years. There are several label-free biosensor techniques commonly used for chemical and biological sensing, including acoustic wave (AW) resonators, cantilevers, electrochemical methods, and surface plasmon resonance (SPR) (Table 8.1). These systems can measure the physical or chemical changes in conductivity, mass, dielectric permittivity, viscoelasticity, and so on without using any label. Also, SPR enables the quantitative analysis of the reaction kinetics of biomolecular interactions.
Target-specific toxicity knowledgebase (TsTKb): a novel toolkit for in silico predictive toxicology
Published in Journal of Environmental Science and Health, Part C, 2018
Yan Li, Gabriel Idakwo, Sundar Thangapandian, Minjun Chen, Huixiao Hong, Chaoyang Zhang, Ping Gong
Experiment data table: This table stores information of over 1,000 assays, the majority of which are cell-based in vitro assays employed in high-throughput screening programs such as Toxicity Forecaster (ToxCast)48 and Toxicology in the 21st Century (Tox21).49,50 Data fields of general descriptive information include chemical supplier, assay identifier, assay type, and experimental condition. Most of the assays are designed for measuring the interaction of chemicals with a specific protein target or assessing the effect of chemicals on RNA or protein expression level. Therefore, the gene or associated protein tested in the assay is also included in the database. Based on this knowledge, linkages between in vitro assays and genes/pathways are established. The assays cover 11 organismal species (Table 1) and 21 tissue types (Table 2), most of which are of human origin.
Bone health, body composition and physical fitness dose–response effects of 16 weeks of recreational team handball for inactive middle-to-older-aged males – A randomised controlled trial
Published in European Journal of Sport Science, 2023
Ivone Carneiro, Peter Krustrup, Carlo Castagna, Rita Pereira, Niklas Rye Jørgensen, Eduardo Coelho, Susana Póvoas
Body (0.01 kg) and FM (%) were measured in a laboratory using a bioimpedance digital scale (Tanita Inner Scan BC 532, Tokyo, Japan), and stature (cm) was determined using a portable stadiometer (Seca 213, Hamburg, Germany), according to standardized protocols (Norton & Olds, 1996). Body mass index (BMI) was calculated as kg/m2. To analyse plasma concentrations of the selected biochemical bone turnover markers, a fasting blood sample was drawn by a trained technician. A 6-mL blood sample tube containing ethylenediaminetetrac acetic acid (EDTA) was collected and centrifuged, and plasma was pipetted and frozen at −80◦C for subsequent analysis of P1NP, OC, CTX, and sclerostin. These markers were analysed by a chemiluminescence method using a fully automated immunoassay system [iSYS; Immunodiagnostic System Ltd., Boldon, UK (P1NP, OC, and CTX) and Liaison XL; Diasorin, Salugia, Italy (sclerostin)]. The manufacturer’s control specimens were used to verify assay performance. The intermediary precisions expressed as coefficients of variation for P1NP were 5.4% (18.96 μg/ L), 6.5% (48.48 μg/L) and 6.1% (122.10 μg/L) for iSYS. For OC, the intermediary precisions were 3.0% (8.73 μg/L), 3.6% (27.6 μg/L) and 3.5% (68.7 μg/L). For CTX were 5.3% (at CTX concentration 213 ng/L), 3.4% (869 ng/L) and 3.5% (2,113 ng/ L) for iSYS. For sclerostin, the intraassay precision was 10% at both the 0.2 and 1.9 ng/mL levels. To evaluate potential changes in body composition the participants were submitted to a dual-energy X-ray absorptiometry scan (DXA; Hologic Explorer QDR, Hologic Inc., Belford, MA, USA). Lower and upper body dynamic strength were evaluated by a chair stand and an arm curl test, respectively, according to standardized protocols (Rikli & Jones, 2013), followed by a postural balance test where the number of falls during 1 min was registered (Deforche et al., 2003). Then, upper body isometric strength was evaluated by a handgrip dynamometer (T.K.K. 5401, Grip-D,Takei, Japan) (Ruiz et al., 2011), and at the end, an agility test (8-foot-up and go) was performed (Rikli & Jones, 2013).