7 Minute Update on Single-Use Systems in Biomanufacturing
Jerold Martin, Chairman at the Disposable Solutions in Biomanufacturing Conference, which recently took place in Europe, believes key issues that the industry needs to be aware of are economics, supply, quality of the equipment and the impact on final drug products.
There is also now a need for standard approaches for safety to meet regulatory requirements. Other main challenges which need to be addressed include safety testing for chemical leachables and concerm about data that needs to be submitted for reguatory approval. Now more than ever, there is greater need for end-users to work closer with their suppliers to insure the supply and quality of single-use components.
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