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Data spaces are a relatively new concept in the field of supply chain management, and they have the potential to revolutionise the way pharmaceutical manufacturers operate. A Data Space is defined as “a decentralised infrastructure for trustworthy data sharing and exchange in data ecosystems, based on commonly agreed principles”. Simply put, data spaces are digital platforms that use advanced technologies such as blockchain and IoT to create an immutable record of all transactions and activities within the supply chain. By providing real-time visibility into the manufacturing process, inventory levels, shipping schedules and much more data spaces can help to optimise production and distribution processes.
The Agency has a vested interest in understanding the specific failure modes and performance challenges of commercially available Rapid Microbiological Methods (RMMs) in comparison to conventional compendial methods in the manufacturing process of biologics drug products to confirm that the recombi…
Following the three presentations by Alfred Penfold, Tom Bannon, Richard Shah, Scott Brady, Aine Brennan and Thomas Page, you'll have the chance you ask your questions…
Key challenges in pDNA manufacturing exist around purification unit operations due to its large size, high viscosity, shear sensitivity, and similarities between pDNA and impurities…
The development of patient centric or clinically relevant specifications builds on existing industry guidance and utilizes the science and knowledge generated through the development and life-cycle of a biologic…