IMMUNOASSAY MANUFACTURING AND LOT MANAGEMENT WHITE PAPER
Abstract
Immunoassay Manufacturing and Lot Management at Rules-Based Medicine, a Q2 Solutions Company
RBM is dedicated to providing high quality immuno- assays to support clinical research success. The key to ensuring our continued excellence is rigorous procedures and care in developing and manufacturing our multiplexed Luminex xMAP® and ultrasensitive Quanterix SimoaTM immunoassay kits. By sourcing the raw materials from qualified vendors under long-lasting supply agreements, we ensure control of assay performance that is impossible to achieve for a typical CRO qualifying and running research kits purchased from life sciences vendors. To ensure lot to lot consistency each lot of our immunoassay kits are qualified to previous lots using archived reference samples . Our extensive experience and quality control steps implemented at every stage from assay development through manufacturing results in consistent high quality biomarker data for our clients’ clinical trial programs.
