Astrea Bioseparations & Thermo Fisher Scientific sign supply agreement for pre-packed bioseparation columns
- Astrea Bioseparations to pack CaptureSelect and POROS chromatography resins in Astrea Bioseparations’ Evolve®D columns;
- Columns packed using validated methods in certified rooms supported by comprehensive regulatory support files.
Ballasalla, Isle of Man, British Isles – January 15th, 2020 – Astrea Bioseparations Ltd, formerly Prometic Bioseparations, announced today that it has entered into a non-exclusive supply agreement with Thermo Fisher Scientific (Thermo Fisher) to manufacture pre-packed Evolve®D columns that include proprietary CaptureSelect and POROS chromatography resins. The agreement follows a period of extensive evaluation of the pre-packed columns, which will be available in early 2020.
Astrea launched the Evolve®D column platform in early 2019, providing Thermo Fisher the opportunity to supply its full range of chromatography resins in a pre-packed column format. The columns and resins are used as part of the molecule purification process to develop biotherapeutics. The agreement is a continuation of the existing relationship between the organizations.
“We have invested significantly in the Evolve®D column platform and leveraged the company’s experience in chromatography resins and clean-room manufacturing to provide a very competitive pre-packed column offering with low lead times,” said Dr. Steve Burton, CEO of Astrea.
Brandon Pence, Vice President and General Manager of Purification and Pharma Analytics at Thermo Fisher, commented: “Combining our resins with the Evolve®D pre-packed columns enables our customers to expedite process development and maximize purification efficiency in their effort to bring novel biotherapeutics to market.”
Dr. Burton added: “Given our established relationship, we are very pleased that Thermo Fisher has selected Astrea as a supplier of pre-packed columns for its chromatography resin products.”
About Evolve®D columns
The current Evolve®D range of pre-packed polypropylene columns comprises fixed column volumes in the range 0.4 L to 6.3 L, with further size columns currently in development, in particular, a range of single use 100ml & 200 ml Evolve®S columns targeting cell and gene therapy manufacturing applications.
Astrea Bioseparations undertakes column packing according to GMP principles in cleanrooms certified to ISO 14644 Class 7. Final column testing includes performance testing (HETP and peak Asymmetry), and bioburden and endotoxin testing of column eluates. The Company also offers column packing studies for adsorbents not previously packed into EvolveD columns and column packing validation studies for clients who require GMP-Ready columns for use in regulated manufacturing processes. Comprehensive regulatory support files can also be provided in relation to GMP-Ready columns. Evolve column housings are supplied to Astrea exclusively by Delta Precision Ltd, Stonehouse, UK. Evolve®, Evolve®D and Evolve®S are registered trademarks of Delta Precision Ltd and used by Astrea under license.
About Astrea Bioseparations Ltd.
Astrea Bioseparations Ltd. (formerly Prometic Bioseparations Ltd) (https://www.astreabioseparations.com/) is a bioseparations company specializing in the research, development, manufacture and marketing of bioseparation products including chromatography adsorbents and pre-packed chromatography columns. A wholly owned subsidiary of Gamma Biosciences, a life sciences tools platform supported by KKR, Astrea Bioseparations has R&D laboratories located at Cambridge, UK and manufacturing facilities located at the Isle of Man, British Isles and Joliette, Quebec, Canada.
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