Abstract - In general the industry is facing pressure to provide a safe, efficacious and secure supply of plasma products on a worldwide basis while at the same time,there is limited capacity for processing. One solution for this problem that is gaining acceptance in the biopharmaceutical industry is the use of flexible facilities containing single use equipment. But operations focusing on plasma processing face some unique challenges that can impact the implementation of single use technologies including batch sizes, historical fractionation processes and large scale chromatography.
A facility design exercise utilizing a combination of single-use technologies and classical stainless steel equipment can represent an attractive option for plasma applications to address these unique challenges.
This presentation will discuss considerations for the implementation of single-use technologies for plasma applications and facilities focusing on operational flexibility, overall process timing and economics.
Merck KGaA, Darmstadt, Germany
Product Manager, Formulation and Final Fill Applications
Pharmaceutical and biopharmaceutical manufacturing
Research. Development. Production.
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