Other content in this Stream
2:03Evolve 450 Column - Refresh Kit Video
Watch how easy it is to change out the wetted parts on the new 45cm diameter column.
31:00Astrea Bioseparations Webinar#6 - The Role of Process Development in Chromatography
Astrea Bioseparations Webinar#6 - The Role of Process Development in Chromatography
Accessory Support Bracket fitting guide
Astrea Bioseparations fitting guide for Evolve columns accessory support bracket
Section 1 - Quality Policy & ISO 9001: 2015 Accreditation
Section 1 contains Astrea Bioseparations Ltd Quality Policy & Accreditation
Section 8 - Additional Information
Section 8 contains a technical user guide and packaging information.
Regulatory Support Files - EvolveD™
The regulatory support file for EvolveD columns contains all relevant support information to use the columns for GMP production purposes.
Section 7 - Stability & Shelf-Life Information
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 - Analytical Information
Section 4 contains analytical information and methods used.
Section 6 - Safety Information
Section 6 contains safety information including shipping studies to demonstrate the column packing robustness.
Section 5 - Extractable & Leachable
Section 5 contains details of extractable and leachables, including supporting documentation on materials of construction, a risk assessment and a column schematic.
Section 3 - Product Specifications
Section 3 contains details of the product specifications, including an example of certificate of analysis and labelling.
Section 2 - Product Information
Section 2 provides a brief overview of the EvolveD column.
Webinar #5 - Challenges of implementing a GMP compliant Quality Management System for Chromatography Media
49:08Astrea Bioseparations Webinar#5 - Challenges of implementing a GMP compliant Quality Management System for Chromatography Media
Learn about our approach to implementing a GMP compliant Quality Management System, the issues that arose and how we dealt with them.
17:53Astrea Bioseparations Webinar#4 - An evolution in disposable solutions
A review of pre-packed EvolveD™ column technologies from Astrea Bioseparations, providing ready to use GMP columns. An open platform suitable for any Bioprocess chromatography media.
31:10Astrea Bioseparations Webinar#3 - Removal of residual Endotoxins from Biopharmaceuticals
Learn about the importance of removing residual Endotoxins from Biopharmaceuticals and the associated challenges this brings.