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CK Life Sciences vice-president and chief scientific officer Dr Melvin Toh said: “The cooperation with XtalPi will apply XtalPi’s AI algorithm, molecular modelling and automated experiments to speed up the R&D process, improve the success rate, and increase the efficacy of tumour vaccines.”.
Structure-based drug design has evolved, facilitating the exploration of novel chemical probes and lead compound potency, and molecular docking utilizes target structures to predict interactions and offers simplicity and speed. Both processes are evolving to enhance product development and output.
Broad pipelines require facilities to be designed with a large degree of flexibility to support anything from mild reaction conditions to the use of potent or highly biologically active compounds. Cone-bottom reaction vessels can provide the turndown required to process a variety of scales and handle different reactions.
The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” The initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics.
The list of potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase.” The initial risk assessment is based on information on the target compound as well as prior knowledge and experience from other products with similar characteristics.
Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. 3 , 27 Advantages POD increases manufacturing flexibility, speed, and consistency. This can simplify future scale-up and technology transfer.
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally.
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