Mimetic Blue® 1 P6XL affinity chromatography adsorbent is developed and manufactured exclusively by Prometic Bioseparations Ltd (PBL). It comprises Mimetic Blue® ligand covalently attached to a near monodisperse 6% cross-linked agarose bead (PuraBead® 6XL) and is immobilised using a defined and highly stable spacer-arm linkage which promotes optimal interaction with the target protein. Mimetic Blue adsorbents can be used for the purification of Albumin, Albumin Fusion Proteins and related proteins from a variety of feedstocks including Plasma, Serum and recombinant cell cultures.
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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.
Section 3 contains details of the product specifications, including an example of certificate of analysis and labelling.
Section 2 provides a brief overview of the EvolveD column.
Learn about our approach to implementing a GMP compliant Quality Management System, the issues that arose and how we dealt with them.