Not Just Disposable Bags! An Analysis Of The One-Step Process For Single-Use Prokaryotic Cell Cultivation

In the world of bioproducts, aseptic risk management and control are of utmost importance, particularly in the production of gene cell therapy products. The National Medical Products Administration has recently issued guidelines emphasizing the use of single-use techniques to prevent cross-contamination. To address the challenges of aseptic control and cross-contamination, a one-step process for single-use prokaryotic cell cultivation (plasmid) production is emergin as a promising solution.

While this one-step process offers advantages, such as preventing contamination, there also are challenges in production stability, controllability, and compliance due to manual connections between different steps in single-use production. To overcome these challenges, OBiO Tech has developed an automation control logic and software that ensures repeatable and stable production control.

Moreover, the output of the single-use process system is comparable to that of stainless steel systems, and the faster turnover rate of the single-use system increases production capacity. OBiO Tech's Lingang Industrial Base is constructing a comprehensive and flexible prokaryotic cell cultivation (plasmid) production platform. This platform offers solutions for various plasmid products and bacterial preparation products.

The platform includes a one-step process for single-use method production line, a triple-tank production line, and a stainless steel system production line. By effectively separating live microbe areas from non-live microbe areas, the platform accelerates the product conversion rate.

Aseptic risk management and control play a crucial role in the production process of bioproducts. Learn how innovative solutions, such as the one-step process for single-use production and automation control logic, ensure stable and efficient production while preventing cross-contamination.