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Early Morning Session
Late Morning Session
QbD principles applied to the development of a capillary gel electrophoresis (CGE) purity & impurity assay focusing on the different steps: Analytical Target profile (ATP) definition, Technology selection, Risk Assessment methodology, Design of Experiments (DoE), Method Validation (Total Error approach) and Control Strategy.
Organic Impurities, especially genotoxic impurities, are critical quality attributes of drug substances and drug products because they have the potential to affect the safety and efficacy. The origin of the impurity may also determine which guidelines (and associated control limits) to follow in the final evaluation of the drug impurity. The scientific results of Leachable Studies, and in particular “screening” leachable studies, may assist in establishing a broad organic impurity profile for drug products, at low concentration levels. It is clear that only by knowing the unknowns, you will gain control.
Early Afternoon Session
Many compounds both in early and late stage development suffers from fairly low solubility making it time and cost consuming to develop formulations for early in-vivo studies, such as pk, efficacy and tox studies. Historically and even up till this day, early formulation development does often follow a manual trial and error approach. We have in contrast developed a high throughput approach to early formulation. This reduces timelines to a matter of a few days and also keeping the need for API in the low mg amount.
Late Afternoon Session
Philae is a comet Lander, part of the ESA Rosetta Mission to comet 67P/Churyumov-Gerasimenko. After about ten years of development and a ten-year cruise through the solar system it successfully landed on the nucleus of the comet on November 12th, 2014.
Since the anchoring harpoons, which were expected to fix the lander to ground, did not work, Philae bounced in the low gravity environment, and only came to rest after a 2 hour’s “hop” in an unforeseen area on the comet surface. Fortunately, the scientific instruments, including cameras, mass spectrometers, a magnetometer and a radar instrument could be operated, and fascinating, unprecedented scientific results have been obtained from the surface of an active comet.
Interplanetary space missions, including a long development phase and elaborated qualification tests do have similarities with pharmaceutical research, where time-spans between the concepts for a new drug until readiness for marketing can be similar.
Rosetta is an ESA mission with contributions from its member states and NASA. Rosetta's Philae Lander is provided by a consortium led by DLR, MPS, CNES and ASI with additional contributions from Hungary, UK, Finland, Ireland and Austria.