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Biopharm purification equipment independently developed by Hanbon includes Chromatography columns, Chromatography system, In-line buffer dilution system, Filtration system, Single-use system, etc. The device software meets the requirements of GLP/GMP regulations and FDA 21CFR part 11 requirements and has a complete IQ/OQ/PQ verification file system that can provide document support for user GMP/FDA certification.
Resin matrix: the finer and more uniform the particle size, the higher the resolution, but also the higher the backpressure (with the exception of the Source matrix);
Physical stability: new generation resins are more robust and can withstand high flow rates while maintaining a stable column bed volume and structure, eliminating the need for frequent column loading operations and improving reproducibility;
hemical stability: the new generation of resins can withstand extreme pH, high salinity, pro-solvents and organic solvents, facilitating the development of separation conditions and in-situ cleaning (CIP), greatly extending resin life and improving reproducibility.
Different packing materials can be used for different sample separations, requiring different columns and systems to be used with them.
Antibody drugs (mono-, di-, poly-, and ADCs) are novel therapeutics with high efficiency, low toxicity, and low side effects, and are widely used in cancer, autoimmune diseases, infectious diseases, and other fields. Antibody-drug purification protocols need to be optimized and adjusted according to specific antibody types and requirements, and downstream links usually include the following steps:
Cell harvesting and fragmentation
Affinity chromatography
Ion exchange chromatography
Size exclusion chromatography
Regeneration and concentration
Hanbon's chromatography systems, filtration systems, in-line dosing systems, and other products are inextricably linked to the separation and purification of antibody drugs and are essential tools for the preparation of high-quality antibody drugs, both in the process development and production stages.
Vaccines are an effective means of preventing infectious diseases. In the process of vaccine preparation, viruses or bacteria need to be produced first by cell culture, etc., and then inactivated and lysed to obtain the vaccine stock solution. Next, the vaccine stock solution needs to be isolated and purified to obtain a high-purity vaccine product. In this process, Hanbon's chromatography system and ultrafiltration system can be used to separate and purify the target proteins in the vaccine stock solution to obtain a high-purity vaccine product. Specifically, affinity chromatography, ion exchange chromatography, and gel chromatography can be used to remove impurities from the vaccine raw material solution to obtain high purity vaccine products.
