ResourceLife Sciences
Effective In Vitro Bioanalytical Assays for Comparing Pharmacodynamics of Biosimilar Monoclonal Antibodies
26 Feb 2013The rise in the development of biosimilar therapeutics has caused increasing demand for new approaches for precise, sensitive, accurate bioanalysis. This white paper describes how a combination of the biopharmaceutical market, regulatory guidelines and the molecular characteristics of biologics has inspired the development of novel ligand-binding assays (specifically, flow cytometry and surface plasmon resonance) that may streamline evaluation of biosimilars.
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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.BiosensorsBiosensors are devices used to detect an analyte using biological molecules specific to the analyte coupled to a detector. Biosensor instruments may be photometric, typically using surface plasma resonance (SPR), electrochemical or QCM (quartz crystal microbalance) biosensors. Biosensors should be selective, portable, robust and sensitive and have a fast response time. Systems may be manual or automated and usually have associated software.ELISAEnzyme-linked immunosorbent assays (ELISA), also known as enzyme immunoassays (EIA), are used for the detection and quantification of proteins, peptides and antibodies in a sample. ELISA often comes in kit format, with pre-selected antibody pairs to detect specific proteins or biomarkers of diseases such as diabetes and obesity, or cardiovascular and neurological disorders. Detection is made possible with chemiluminescent, fluorescent or colorimetric substrates and detection instruments such as microplate / ELISA readers. Other kits available include: Enzyme-linked immunospot (ELISPOT) assays for the quantification of protein-producing cells and chemiluminescent immunoassays (CLIA) kits. Find the best ELISA kits and products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ProteomicsProteomics is the systemic bioinformatics study of proteins and amino acids, including their structure, size, function and identification. Tools used in proteomics include chromatography, blotting and gels, protein arrays, mass spectrometry and ELISA and associated analysis software. Analyzers and proteomic systems should be sensitive, high resolution, fast and may be automated for high-throughput.Flow Cytometry / Cell CountingFlow cytometers are used to count, sort and examine multiple characteristics of cells. Other cell analysis equipment includes image cytometers, cell counters, fluorescence-activated cell sorters (FACS), magnetic-activated cell sorters (MACS), and a range of flow cytometry assay kits. Flow cytometers can reveal information on cell viability, cell proliferation, apoptosis and cell cycle progression, as well as identify cell populations and intracellular or cell-surface molecules. Additionally, some flow cytometers, known as FACS, have an additional sorting function after analysis. Cell counters and image cytometers count live and dead cell populations and can also conduct cell proliferation assays. Find the best flow cytometers, cell counters and cell sorters in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.Surface Plasmon ResonanceCytometryCytometry is a broad term for the quantitative analysis of cells and cell systems. The most popular methods to study cytometry are flow cytometry and image cytometry.BiosimilarsBiosimilars are very similar versions of approved and authorized medicines. Clinically inactive components will have minor differences, but there are no significant differences between the biosimilar and the original product in terms of potency, purity and safety.TherapeuticsTherapeutics are treatments designed to alleviate or cure diseases. These include pharmaceuticals, biologics, and gene therapies, which work by targeting specific disease mechanisms. Advances in personalized medicine and biologics offer new hope for patients with conditions that were previously difficult to treat. Browse our peer-reviewed product directory to find therapeutic solutions for various diseases; compare products, check user reviews, and get pricing directly from manufacturers.Therapeutic AntibodiesTherapeutic antibodies are antibodies engineered for use in treating diseases. They can be designed to target specific antigens, blocking harmful interactions or modulating immune responses. Therapeutic antibodies are critical in treating conditions like cancer, autoimmune disorders, and infectious diseases. Explore the best therapeutic antibody products in our peer-reviewed product directory; compare options, check reviews, and get pricing directly from manufacturers.Monoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.