Bioseparations Hub

  • Strategies for selectivity manipulation in Boronate Affinity Chromatography - Infographic

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  • Astrea Bioseparations Webinar#7   Manufacturing of Affinity Chromatography products23:47

    Astrea Bioseparations Webinar#7 Manufacturing of Affinity Chromatography products

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  • Evolve 450 Column - Refresh Kit Video2:03

    Evolve 450 Column - Refresh Kit Video

    Watch how easy it is to change out the wetted parts on the new 45cm diameter column.

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  • Astrea Bioseparations Webinar#6 - The Role of Process Development in Chromatography31:00

    Astrea Bioseparations Webinar#6 - The Role of Process Development in Chromatography

    Astrea Bioseparations Webinar#6 - The Role of Process Development in Chromatography

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  • Astrea Bioseparations announces acquisition of Essential Life Solutions

    Astrea Bioseparations announces acquisition of Essential Life Solutions

    Astrea Bioseparations announces acquisition of Essential Life Solutions

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  • Accessory Support Bracket fitting guide

    Accessory Support Bracket fitting guide

    Astrea Bioseparations fitting guide for Evolve columns accessory support bracket

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  • General Operating Manual for Evolve 200 to 250mm columns v2

    General Operating Manual for Evolve 200 to 250mm columns v2

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  • Section 1 - Quality Policy & ISO 9001: 2015 Accreditation

    Section 1 - Quality Policy & ISO 9001: 2015 Accreditation

    Section 1 contains Astrea Bioseparations Ltd Quality Policy & Accreditation

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  • Section 8 - Additional Information

    Section 8 - Additional Information

    Section 8 contains a technical user guide and packaging information.

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  • Regulatory Support Files - EvolveD™

    Regulatory Support Files - EvolveD™

    The regulatory support file for EvolveD columns contains all relevant support information to use the columns for GMP production purposes.

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  • Section 9 - Content Summary

    Section 9 - Content Summary

    Section 9 contains version control and document approval.

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  • Section 7 - Stability & Shelf-Life Information

    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.

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  • Section 4 - Analytical Information

    Section 4 - Analytical Information

    Section 4 contains analytical information and methods used.

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  • Section 6 - Safety Information

    Section 6 - Safety Information

    Section 6 contains safety information including shipping studies to demonstrate the column packing robustness.

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  • Section 5 - Extractable & Leachable

    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.

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  • Section 3 - Product Specifications

    Section 3 - Product Specifications

    Section 3 contains details of the product specifications, including an example of certificate of analysis and labelling.

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  • Section 2 - Product Information

    Section 2 - Product Information

    Section 2 provides a brief overview of the EvolveD column.

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  • Webinar #5 - Challenges of implementing a GMP compliant Quality Management System for Chromatography Media

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  • Astrea Bioseparations Webinar#5 - Challenges of implementing a GMP compliant Quality Management System for Chromatography Media49:08

    Astrea 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.

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  • Webinar #4 - An Evolution in Disposable Solutions

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