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Product Protective Capture and Elution of Biopharmaceutical Agents


Abstract

The field of application of this product-sparing affinity chromatography lies in the field of Life Science / White Biotechnology / Cell Lines and Medicine / Pharmaceuticals. It enables the direct processing of biopharmaceutical active substance molecules from cell culture supernatants with the help of ligands of special quality (see also 16265 / InnoLand).

Biotechnologically produced active substances are usually worked up by multistage chromatographic separation processes as shown in the figure below (see Fig. 1). By affinity-chromatic process steps, high purification factors can be achieved with low yield losses.


Background

The biotechnological production of biopharmaceutical active substances using multi-stage chromatographic separation processes should be as gentle on the product as possible and cost-effective.


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Problem

The conventional separation of affinity-bound active substance molecules from the separation column in the multi-stage chromatographic separation processes with neutral pH does not achieve satisfactory results.


Solution

The invention describes a process that enables the gentle affinity purification of biopharmaceuticals at neutral pH. Finally, the bound glycoproteins are released at neutral pH with an elution buffer containing a competitively binding substance. The invention also describes simple new multivalent ligands with significantly higher specificity and selectivity than previous monovalent boronates. This enables the selective purification of biopharmaceuticals that lose therapeutic activity and product quality due to acid elution.


Advantages

  • Containment of manufacturability risk
  • Monitoring effort and in-process controls can be saved
  • efficient removal of product- and prodcess-related impurities at the very first downstream step
  • Non-immunologic ligand - less effort for leachables monitoring
  • Possible further applications for dedicated virus removal.

Scope of application

The invention enables the direct processing of biopharmaceutical active substance molecules from cell culture supernatant by means of low-cost affinity chromatography, which is particularly gentle on the product.


Service

License for commercial use, cooperation


EZN Erfinderzentrum Norddeutschland GmbH

Dipl.-Ing. Susanne Deutsch
0511 850 308-0
s.deutsch@ezn.de
www.ezn.de
Address
Theaterstraße 2
30159 Hannover



Development status

Feasibility


Patent situation

  • EP 2 998 008 B1 (validiert in DE, FR und GB) granted

Keywords

Affinity chromatography, purification, biopharmacy, biotechnology, chromatography, elution, inventor: Prof. Dr. Henning von Horsten, glycoproteins, HTW Berlin, life sciences, ligand, medicine, ph-value, pharma, protein, buffer, column material, total synthesis, separation column, separation process, virus, active ingredient, cell culture, cell lines

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