FIELD: chemistry.
SUBSTANCE: invention relates to a method for reducing bioburden (e.g. sterilization) of a chromatography resin, including exposing a container containing a composition comprising a chromatography resin and at least one antioxidant agent to a dose of gamma radiation sufficient to reduce the bioburden of the container and the chromatography resin, where at least one antioxidant and/or chelator are present in an amount sufficient to reduce the loss of binding capacity of the chromatography resin after exposure to a dose of gamma radiation. Also the present invention relates to a composition comprising a chromatography resin and at least one antioxidant.
EFFECT: proposed are sterile chromatography resin and its use in production methods.
36 cl, 11 dwg, 4 tbl, 5 ex
| Title | Year | Author | Number |
|---|---|---|---|
| STERILE CHROMATOGRAPHIC RESIN AND ITS APPLICATION IN PRODUCTION METHODS | 2015 |
|
RU2805607C2 |
| METHODS FOR STERILE CHROMATOGRAPHY AND PRODUCTION | 2015 |
|
RU2786078C2 |
| STERILE CHROMATOGRAPHY AND MANUFACTURING PROCESSES | 2015 |
|
RU2679133C2 |
| STERILE CHROMATOGRAPHIC RESIN AND ITS APPLICATION IN PRODUCTION METHODS | 2019 |
|
RU2809157C2 |
| INTEGRATED CONTINUOUS PRODUCTION OF THERAPEUTIC PROTEIN-BASED MEDICINAL AGENTS | 2014 |
|
RU2768003C2 |
| CULTIVATION PROCESSES IN SEED FERMENTER SYSTEM AND THEIR APPLICATION METHODS | 2015 |
|
RU2786997C2 |
| METHOD OF CULTIVATION IN SYSTEM OF INOCULATING FERMENTORS (EMBODIMENTS) | 2015 |
|
RU2694327C2 |
| INTEGRATED CONTINUOUS MANUFACTURING OF THERAPEUTIC PROTEIN DRUG SUBSTANCES | 2014 |
|
RU2662929C2 |
| PRODUCT QUALITY ATTRIBUTE MEASUREMENT | 2020 |
|
RU2825307C1 |
| METHODS FOR PROCESSING FLUID CONTAINING RECOMBINANT THERAPEUTIC PROTEIN AND THEIR APPLICATION | 2017 |
|
RU2751506C2 |
