Webinar #5 - Challenges of implementing a GMP compliant Quality Management System for Chromatography Media
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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
Astrea Bioseparations announces acquisition of Essential Life Solutions
Astrea Bioseparations announces acquisition of Essential Life Solutions
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.
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.