This webcast features: Parag Patel, Senior Regional Manager, Asahi Kasei Bioprocess
Viral clearance of biopharmaceutical- and plasma-derived therapeutics is an important regulatory requirement that ensures patient safety. Although there are many viral clearance strategies and technologies that can be deployed, size exclusion filtration remains the gold standard in virus removal. Virus filtration by size exclusion is a robust method for removing virus without impacting the efficacy of the final drug product. We will take you through the steps of developing a robust manufacturing process using Planova™ BioEX virus removal filters with consideration of existing manufacturing suite configurations and requirements, including examples with stainless steel and single-use equipment. From selecting a virus filter during process development, retaining predictable performance during scale up, and implementing Planova BioEX within your unique manufacturing suite, we will highlight the key considerations that go into implementing a successful viral clearance step.
Asahi Kasei Bioprocess draws on 30 years of experience implementing Planova filters in unique manufacturing settings, conditions and customer needs.
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