americanpharmaceuticalreviewMarch 13, 2020
Tag: Astrea Bioseparations , Thermo Fisher Scientific , EvolveD
Astrea Bioseparations, formerly Prometic Bioseparations, has entered into a non-exclusive supply agreement with Thermo Fisher Scientific to manufacture pre-packed EvolveD™ columns that include proprietary CaptureSelect and POROS chromatography resins.
Astrea launched the EvolveD 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 EvolveD 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.
"Combining our resins with the EvolveD pre-packed columns enables our customers to expedite process development and maximize purification efficiency in their effort to bring novel biotherapeutics to market," Brandon Pence, Vice President and General Manager of Purification and Pharma Analytics at Thermo Fisher, said.
The current EvolveD 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 EvolveS™ columns targeting cell and gene therapy manufacturing applications.
Astrea 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.
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