Pharmaceutical Manufacturing and Release Testing

After final FDA approval of a new drug, large-scale manufacture can begin. Pharmaceutical manufacturing requires continual monitoring of all aspects of the process: raw ingredients, manufacture, packaging, and storage. Each jurisdiction has codified good manufacturing practices (GMPs), specifying the workflow, record-keeping, and quality requirements for the manufacturing process. The particular drug and the specific manufacturing processes determine the type and number of tests carried out by quality control (QC) laboratories. Show more

Production runs must be routinely monitored for many factors. This so-called release testing can include identification and assay of active substance(s) and excipients, purity assays including measurement of breakdown products and contaminants, and appropriate pharmacological testing such as dissolution. The advent of biopharmaceuticals (biologics or biologicals) and the use of expression systems necessitate the identification and measurement of any residual host cell protein (HCP) or host cell DNA (HCD) in the product. To ensure the safety of the finished product, the target level for residual host cell protein in a drug substance is set at 100 ng/mg or less and 100 pg or less for residual host cell DNA. Show less