Automation of sample preparation and sample management provides efficiency gains when evaluating developability of drug compounds

Description:
In the compound design and selection phase of pharmaceutical development it is of great importance is to look at physico- chemical properties to assess the ability to design and manufacture drug products. Solubility and chemical stability are two areas that needs to be measured and evaluated. Early in the discovery phase there are often automated basic setups applied in screen settings, however optimised for discovering major issues related to in-vitro tests. When approaching development more in-depth characterisation is needed to not only enable cross comparison of compounds, but as important to guide development. Compound specific questions are being asked, such as: What solid state is the solubility measured on? Has a stability indicating separation methods been used for analytical evaluations?
Automation is a need for a lab to meet today’s deadlines with rapid decision making. To achieve quality and set a strategy for development, a flexible liquid handling work table has been developed that facilitate sample preparation for several investigations in the pre-clinical space of drug development. For example, forced degradation is one of the starting points for method development and stability, where compounds are exposed to different reagents and temperatures to assess ability and potential of degradation pathways. To achieve efficiency, an automatic sample manager with various temperatures is used. The autosampler is setup so that new samples can continuously be added and automatically be inserted in the ongoing run. The flexibility achieved makes it possible to move away from batch performance and allows for several assays/methods being executed on the same system. The examples that will be presented will show that that it is possible to gain some efficiency by automation and keep the flexibility needed, moving from screen settings to answering compound specific questions.

Speaker: Jenny Ottosson - Advanced Drug Delivery, Pharmaceutical Sciences, Bio Pharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
Jenny Ottosson, with a motto ”we play to win”, is an Associate Principal Scientist in analytical science within Pharmaceutical Sciences at the AstraZeneca site in Mölndal Sweden. One main part is driving and take lead in improvements to progress the pharmaceutical projects. Current focus is setup of new automation capabilities aiming for efficiency for projects transferring from discovery into development and the early clinical phase. Jenny has worked in the field within the industrial pharmaceutical area for 21 years, spanning from early pre-clinical to late clinical Phase, and her strength is in separation science. Together with her educational background in material science and chemical engineering, and her extensive experience as a project manager, her knowledge of the early development phase is key for finding new ways to optimize early workflows. Apart from the technical skills, Jenny brings energy and strives for constant improvements in her work.