Insight I Sino Bioengineering

To ensure correct working order and control over the different functional elements, the facility is overseen by two high-level, interdependent, but separate, control systems. These a……

The importance of the design and installation of systems for supplying utilities that do not come into contact with products (e.g., heating steam, control air, coolants) is often und……

Large quantities of waste will be generated from the biopharmaceutical facility during production. The vast majority of this waste emanates from the production process, but waste als……

Biopharmaceutical clean rooms typically house processes and equipment requiring utilities such as water, electricity, and compressed air. The sources of these utilities are usually l……

The HVAC system is fundamental to achieving the control of the environmental conditions within the biopharmaceutical facility. This is to provide workers with a comfortable working e……

Single-use systems have, in the last decade, become a fully accepted component in biopharmaceutical production. Their uptake has been predominantly in the use of buffer and cell cult……

Instead of the huge, 10-ton, or even higher, annual production scale facilities for one single biopharmaceutical product, it seems more likely that many current and most future facil……

A significant issue in complying with cGMP regulations is the decision that the designer needs to make concerning the balance between physical facility solutions and procedural solut……

Segregation practices form the fundamental design strategy for the prevention of cross- contamination and protection of quality of the final bulk and intermediate products throughout……

Once the production capacity of the facility is determined, the overarching boundaries and constraints of the facility design are fixed. Regardless of the differing variables effecti……

The decision to design and build a new facility or expand an existing one almost always comes down to the business drivers of additional revenue and market share. For the biopharmace……

The first biopharmaceutical facilities for large-scale cultivation of recombinant micro-organisms were designed and commissioned decades ago . The relatively meager competitive lands……

During process scale-up, scale-independent variables including temperature, pH, dissolved oxygen setpoint and feeding strategy can be readily maintained stably. Nevertheless, scale-r……

Monoclonal antibodies (mAbs) are predominantly produced using Chinese hamster ovary (CHO) cells in large-scale bioreactors. Process development commences at small scales including sh……

In modern biopharmaceuticals, fermentation serves as a cornerstone for manufacturing diverse therapeutic products owing to its versatility and high efficiency. It enables large-scale……

Intelligentization and scale-up simulation of bioreactors serve as pivotal breakthrough points to overcome core bottlenecks in the industrialization of biomanufacturing. Essentially,……