Зафиксированная дата: June 25 2020
The challenges of differentiated drug product development, increased pressure from generic products, and low rates of return on development costs are all factors driving pharmaceutical companies to seek strategies to accelerate and de-risk their product development. Their ultimate aim is a more rapid realization of pipeline value.
Key to their success is a data-driven, ‘win quick, fail fast’ approach to reduce technical uncertainties faced during the early stages of development by screening candidate NCEs against developability and processability requirements. Application of approaches such as the Developability Classification System (DCS) and Manufacturing Classification System (MCS) helps identify those candidate molecules and formulations which are likely not only to meet bioavailability requirements but also to be successful during scale-up and into commercial manufacturing. These classification systems are enabled through relevant physicochemical analysis approaches which provide the data needed to link decisions made during lead optimization and API salt and polymorph selection to the critical material attributes required to meet both product and process requirements.
In this webinar, we will introduce a unique new service: Amplify Analytics, which has sprung from a partnership between Spectris companies Concept Life Sciences and Malvern Panalytical, and our collective understanding of our customers’ requirements and aspirations relating to drug developability assessment.
This collaboration binds together Concept Life Sciences’ expertise in discovery chemistry, API screening and GMP manufacturing with Malvern Panalytical’s extensive capabilities for detailed solid and morphological form analysis. As an integrated team, we empower our customers to quickly and confidently identify those candidate NCEs which are most likely to meet bioavailability and manufacturability requirements.
The Amplify Analytics service improves pharmaceutical development outcomes by directly linking API selection to both ADMET and microstructural assessments, ensuring developable candidates are rapidly and accurately identified. In addition, the Amplify Analytics team can directly deploy the physicochemical characterization techniques and methods required to ensure process and quality control within our customers’ organizations, supporting scale-up and manufacturing programs. This is a unique partnership which integrates API selection, manufacturing and characterization, accelerating product development to deliver improved development outcomes and a much faster return on investment.