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The amount, types, and scale of single-use technologies have changed and increased significantly, adding an extra burden on facility design and operations.
At the Phaciliate Leaders World stakeholders across the cell and gene therapy supply chain stress that quality of starting material will be key to the success of cell and gene therapies.
BioPhorum has identified technology and regulatory gaps for continuous downstream drug-substance processing using a monoclonal antibody (MAb) as a model system.
The cell therapy sector faces a cost of goods sold (COGS) crisis and needs to get beyond the “product is the process” mind-set says Dark Horse Consulting.
The core of the 2010 China GMP guidelines is quality risk management, a systematic process for evaluating, controlling, and reviewing the quality risks of a medicine throughout its lifecycle by introducing ICH Q9 and Q10 guidelines
The third part of this series on single use products in the manufacture of cell therapies from BPSA covers ensuring supply chain security and describes strategies for working with suppliers.
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A growing number of biomanufacturers are turning to new aseptic fill–finish technologies, including blow–fill–seal systems and single-use equipment.This article covers core considerations and new technologies that manufacturers are using.
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Synthesizing and purifying long RNAs can pose unique challenges due to their sequence composition, secondary structure, and applied modifications.
