
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
MilliporeSigma released a new surface-active nonionic polymer to ensure lot-to-lot consistency.
Poloxamer 188 EMPROVE EXPERT, a surface-active nonionic polymer from MilliporeSigma, is used in cell culture media as a shear protectant and increases robustness of mammalian cells to shear from sparging, resulting in increased viability of cells in the bioreactor, the company reports.
The polymer, which was developed to help ensure lot-to-lot consistency and reliable performance, has been cell-culture tested and optimized. The product comes with polymer dossiers to help manufacturers meet regulatory requirements for risk assessment.
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