The pre-packed 50 mL columns have been specifically designed to be cost effective and robust. The disposable 10cm bed height columns provide a platform for fast and accurate process development and can also be employed as polishing steps for the binding and purification/removal of target biomolecules or contaminants
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Astrea Bioseparations fitting guide for Evolve columns accessory support bracket
Section 1 contains Astrea Bioseparations Ltd Quality Policy & Accreditation
Section 8 contains a technical user guide and packaging information.
The regulatory support file for EvolveD columns contains all relevant support information to use the columns for GMP production purposes.
Section 9 contains version control and document approval.
Section 7 contains information related to stability and shelf life of the packed columns. This includes an efficiency study, mechanical stability study (of the empty column) and a sanitisation study.
Section 4 contains analytical information and methods used.
Section 6 contains safety information including shipping studies to demonstrate the column packing robustness.
Section 5 contains details of extractable and leachables, including supporting documentation on materials of construction, a risk assessment and a column schematic.