A Novel Membrane Adsorber for HIC
A new phenyl membrane adsorber was designed for purification of biomolecules based on Hydrophobic Interaction Chromatography (HIC) principles. The novel phenyl membrane adsorber features high flow rate and high binding capacity providing a new scalable and disposable tool for purification and separation of biomolecules as well as for polishing applications in the biopharmaceutical industry.
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Specification Equivalence—A Practical Approach
December 30th 2024Article
In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
