BioOutsource Launches Comprehensive Range of Off-the-Shelf Testing Methodologies to Support Biosimilar Characterization & Comparability Testing

23 Sept 2013
Kerry Parker
CEO

Product news

BioOutsource Ltd., a leading international Contract Testing Organization (CTO) has consolidated its position as the leading expert in the biological analysis of Biosimilar Monoclonal Antibodies for the biopharmaceutical industry. Strategic internal R&D investment has enabled the creation and launch of a wide range of off-the-shelf testing methodologies to support comparability, stability and lot release testing for Biosimilars. As a result the company has achieved excellent market penetration and sales growth this year and is now working in collaboration with many of the world’s leading Biosimilar companies.


“Our extensive experience in developing and validating cell-based assays and strategic R&D investment has created a niche position for us within the industry, which enables BioOutsource to provide testing solutions that can significantly reduce the time and cost of Biosimilar development programmes,” commented BioOutsource CEO Gerry MacKay. “We are continuing to invest and expand our testing capabilities in Glasgow, Scotland and are significantly increasing commercial activities in the North American and Asia-Pacific regions to support surging demand for Biosimilar characterisation & comparability testing. We are delighted to be working with more than 30 of the top Biosimilar players globally, and look forward to continued strong growth in 2014.”

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ADME-ToxicologyADME-toxicology (ADME-Tox) studies are used in pharmacology and pharmacokinetics to assess the activity/toxicity of drugs <i>in vivo</i> or <i>in vitro</i>. Find bioassays for absorption, distribution, metabolism, and excretion of drug molecules including cytotoxicity, transporter/permeability, metabolism and activity assays as well as hepatocytes and cell lines for ADME. Find the best ADME-toxicology products 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.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.ImmunoassayImmunoassays are laboratory tests that utilize antibody-antigen interactions to detect specific substances. They are widely used in diagnostics for detecting diseases, drug testing, and environmental monitoring. These assays offer rapid, sensitive, and precise detection of biomarkers, making them invaluable in clinical and research labs. Browse our peer-reviewed product directory to compare immunoassay systems, read user reviews, and get pricing directly from manufacturers.Cell AnalysisThe analysis of cells allows researchers to understand the factors which contribute to cell health and function. These influencing processes can then be predicted and altered, leading to the development of medication and disease treatments.PharmacokineticsBiosimilarsBiosimilars 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.Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.
BioOutsource Launches Comprehensive Range of Off-the-Shelf Testing Methodologies to Support Biosimilar Characterization & Comparability Testing