Application of one-time mixing technology in low pH incubation virus inactivation process
The perfect interpretation of the excellent performance of one-time mixing technology --Application in low pH incubation virus inactivation process
"Mixed" is an ordinary noun that can't be ordinary. Everyone can hear it everywhere in life. The fragrant coffee, the refreshing and refreshing drink, these well-known drinks in life are made by mixing different ingredients. The mixing process is done by a stir bar. However, in the professional large-scale biopharmaceutical industry production field, especially in the low-pH hatching virus inactivation process with high-risk and high-tech operation difficulty, how do we carry out effective mixing while ensuring the safety of the process, Sedoli The one-time mixing technology will give you the perfect solution.
At present, virus removal and inactivation have become an indispensable process step in the production process of biological products. The guidelines for quality control techniques for human monoclonal antibodies published by SFDA also recommend the addition of virus removal/inactivation methods. Taking the antibody production process as an example, in addition to the recovery rate and purity, the virus must be effectively inactivated and eliminated in the purification process of the antibody. Generally, the most effective virus removal/inactivation methods include: low pH, heating, S /D (solvent / detergent), membrane filtration, etc. In the design of antibody process, the typical design is to add a virus inactivation process after Protein A affinity chromatography, and this step is to elute the sample at low pH, so it is eliminated by low pH incubation. Live viruses are the easiest and quickest way.
In view of the current stage and scale of domestic monoclonal antibodies, it is relatively common to use conventional systems to perform low pH inactivation steps, such as glass bottles with magnetic stirring rotors or simple stainless steel tanks. Although the traditional method is relatively simple, it inevitably produces the following problems:
1. Poor mixing effect or excessive shear force, resulting in long adjustment process or large antibody loss;
2. The pH is detected offline, the speed is slow, and the data cannot be fed back in time; it is easy to adjust to expose the antibody to a poor environment for a long time, resulting in an increase or even precipitation of the polymer or the charge isomer;
3. The risk of introducing a bioburden into a system that is sampled or opened multiple times;
4. Tank cleaning/cleaning verification and risk of cross-contamination.
Faced with the problems brought by the traditional methods, the launch of the new disposable mixing system avoids the above risks. Moreover, its on-line detection of pH and ultra-clean, low-shear mixing characteristics makes the entire low-pH incubation virus The speed and yield of inactivation are greatly improved, and it is a safe and efficient mixing method. Sartorius uses a series of experimental comparisons to illustrate the advantages of the new disposable mixing technology in low pH virus inactivation.
The new disposable mixing system features a unique cube structure design and low shear paddle design, combined with a disposable pH electrode for real-time in-line pH monitoring, which greatly reduces cross-contamination, particle release, and biology in a low pH incubation virus inactivation process. Risk of load introduction, rapid and efficient mixing and precise pH adjustment and control, reducing the exposure time of biological products in adverse environments, minimizing the loss of effective active protein components and the production of precipitates, polymers and isomers, To meet the needs of safe and efficient production of high-value biological products, the concept of one-time system design has improved the safety and efficiency of the entire process, while effectively reducing the cost of investment in fixed equipment.
Sartorius' new disposable mixing system consists of a magnetic hybrid system and a magnetic levitation system, both of which offer a choice of 50L-1000L in different sizes to meet the needs of the process from R&D, pilot to production. In addition, the hybrid system can be integrated with the FlexAct automation platform (pictured, FlexAct VI) for fully automated control of low pH incubation virus inactivation, making the entire process faster, safer and more efficient.
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