Ensuring the viral safety of plasma-derived medicinal products is paramount, and viral clearance by purification processes is integral to achieving this. At Prothya Biosolutions B.V., the use of Planova 20N filters has reliably demonstrated a robust capacity for mitigating the risk of adventitious viruses in PCC and IgG products.
Recently, Asahi Kasei introduced its next-generation regenerated cellulose virus filter, Planova S20N. This new model promises “superior” filtration performance, “secure” robust virus removal capability, and “simplified” operation for post-use integrity testing.
Invited by Asahi Kasei to evaluate the potential integration of Planova S20N filters into our manufacturing process, Prothya Biosolutions B.V. has undertaken a comparative study of these filters with the existing Planova 20N filters. Protein filtration capacity studies for both products are performed. A comparison regarding the effective filter area to be used per manufacturing batch and other process parameters is made.
Additionally, virus validation studies were conducted at ViruSure in Vienna, Austria, to verify the virus removal capability of the Planova S20N filter. The findings of these comprehensive studies and evaluations are presented in this webinar.
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