ResourceLab Automation
Optimizing a PK assay for reliable data
11 Apr 2024Pharmacokinetic (PK) assays play a crucial role in quantifying biopharmaceuticals, biomarkers, and immunogenicity, guiding critical decisions in drug development and ensuring the reliability of obtained data. Mercodia discusses the re-optimization of a pharmacokinetic assay, highlighting improvements made to enhance reliability, precision, and efficiency. Key changes include minimizing false positives, implementing urgent and long-term solutions for non-specific responses, and addressing edge effects in plate assays. The re-optimized assay underwent validation and was successfully utilized in phase 1 and phase 2 clinical studies, demonstrating its effectiveness in providing reliable data for drug development.
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Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.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.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.PharmacokineticsData ManagementAssay 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.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.