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Raw Material Data Poised to Reduce Biopharmaceutical Variability

 
• By Bowman Cox

An initiative to increase the speed and extent of raw material data flow could enable biopharmaceutical companies to reduce the variability and increase the reliability of their manufacturing processes. Amgen shares successes with internal trending exercise and discusses proposed ASTM E55 data standard for use by the industry and its raw material suppliers.

An international standard-setting organization is considering adopting an electronic data format like the one Amgen Inc. uses with suppliers to monitor and enhance the quality of raw materials used in its biopharmaceutical manufacturing processes.

Electronic interchange of raw materials data between manufacturers and their suppliers could enable them to reduce variability and increase reliability...

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