Quality systems, including Quality Control (QC) and Quality Assurance (QA), ensure that patients receive a safe, pure, potent, and stable product. While there are considerable similarities between biopharmaceuticals and chemically synthesised drug products, the QA/QC issues and challenges are very different in some respects. Raw materials of biological origin are carefully selected and extensively tested to minimise the risk of microbial contamination of the cell culture systems.
Although biopharmaceuticals can be characterised chemically to varying degrees, it is generally accepted that the structure-function relationships and key determinants of activity for biologics are not fully determined. For these reasons, most biopharmaceuticals require some element of biological testing in addition to chemical testing, as part of routine quality control processes. Immunological, biochemical, or bioassay techniques are often used to determine the concentration and activity of the active ingredient. There is heavy reliance on in-process sampling and testing as well as testing of the final drug substance and drug product due to the complexity of the molecules. As most bio-pharmaceuticals are provided as injectable solutions and are administered parenterally, careful attention is paid to the maintenance of sterility of the final product.
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