When validating a method according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, it is necessary to perform a linearity experiment. This requires the preparation of multiple calibration levels, analysis of the samples by liquid chromatography, and calculation/reporting of the results. Each of these steps can be very time consuming, and in many cases error prone. This is especially true if the analytical method being tested requires the measurement of multiple components. Continue reading
There are many stages in the drug discovery process where powder dosing is required, in varying target amounts and batch sizes, and into a wide range of different target containers. As new drugs become more effective and more potent, there are also greater risks for the people who are exposed to these compounds during development and formulation. Continue reading
Last week, I had the opportunity to attend the BioProcess International Conference in Providence, RI. Many of the sessions I attended highlighted the advancement of the Bio-Pharmaceutical industry in applying the principles of Quality by Design (QbD). Continue reading
In Quality Assurance and Quality Control (QA/QC), the amount of time and money spent on out-of-specification investigations and inconclusive results can be decreased by eliminating errors in weighing and sample preparation.