Spectroscopy In-Depth Focus 2018
This In-Depth Focus examines methods to improve efficiency on the production line and explores a LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics.
- NIR inspection of each tablet that exits a tablet press
In the pharmaceutical industry, waste represents at least 25 percent of the cost of quality.1 In 2004, the Food and Drug Administration (FDA) published a guide to promote the implementation of Process Analytical Technologies (PATs) in the pharmaceutical industry. This would allow better quality control (QC) and monitoring directly on the production line. The FDA encouraged manufacturers to use the PAT framework to develop and implement effective and efficient innovative approaches in pharmaceutical development, manufacturing and quality assurance, including continuous real‑time quality assurance.
- LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics
For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive training requirements are needed for instrument operators, there is difficulty in generating comprehensive standard operating procedures (SOPs), and finally the price of the equipment. Additionally, there has been a tendency to diminish the importance of the information obtained from the mass spectrometric data as being redundant to and not always consistent with the information generated from the data of traditional product release assays.
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