Biotechnology progress
A case study showing the role of hydrophobicity variants and other enriched mAb proteoforms on filterability through a virus filter with productivity improvement measures.
Solomon Isu, Derek Silva, Melissa Holstein, Angela Lewandowski, Kristina Cunningham, Adam Sokolnicki, Bala Raghunath
Published: 202610.1002/btpr.70101
Abstract
A rapid assessment of manufacturability for drug candidates is crucial for advancing a prospective biotherapeutic from a candidate to a bulk drug substance. A lot-to-lot approach to manufacturability is adopted where each biologic batch is assessed f…
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