Bio-Fermentation in the Pharmaceutical Industry

When referring to fermentation in the industrial process sphere, most people’s thoughts may automatically jump to the food & beverage industry. They may think of wine or cheeses or bread; familiar delicacies that fermentation is often associated with. What most people may not immediately think of when referring to fermentation, however, is the pharmaceutical industry.

Fermentation, or ‘bio-fermentation’ in the pharmaceutical industry, refers to the process of harvesting pharmaceutical, therapeutic material from biologic material. Bacteria, enzymes, proteins, cells, fungi, and plant material all play large roles in the manufacturing of pharmaceuticals. The harvested material from these cell cultures produces a wide range of products, including antibiotics, hormones, vaccines, and other medicines.

The Challenge

A type of broth typically houses the biologic material extracted for fermentation. The broth travels from various tanks, separators, and purifiers, undergoing temperature and molecular changes as it makes its way through the process. Measuring pH and dissolved oxygen are essential measurements in the bio-fermentation process. The intended molecular reactions that produce the extricable material are heavily dependent on both pH and dissolved oxygen (DO) values. The solution’s pH must be a precise value, based on the reactive nature of the desired protein or cell culture being extracted. Additionally, the broth must sustain certain DO values to support the microorganisms and their role in the fermentation process. This means operators must frequently implement dosing agents to maintain these variables at their optimal levels.

Cellular fermentation requires precise conditions in a sterile environment. Creating an environment suitable for the proper molecular reactions involves many steps. However, due to the pharmaceutical nature of the extracted material, maintaining sterility in this process is essential. Manually handling probes and other instrumentation risks compromising sterility. Frequent calibrations and manual cleanings can threaten sterility. Additionally, bio-fermentation is a drawn out process. Weeks of operation may be necessary to obtain the desired reaction and purification. Sensors, transmitters, and holders must maintain their function for extended periods of time to achieve efficient and sterile fermentation.

The Solution

Introducing automated systems to the bio-fermentation process enables operators to maximize process efficiency and sterility. The Uniclean 900 cleaning and diagnostics system is ideal for the dissolved oxygen needs of bio-fermentation. When paired with the Protos transmitter and a Sensogate or Ceramat pneumatic retractable holder, the Uniclean 900 is the ideal engineered solution for the automatic retraction, cleaning, and insertion of inline process sensors. Coupling the SE 740 DO sensor with the Uniclean allows operators to decrease their reliance on manual cleanings and boost process sterility and performance.

For pH measurements, the durability of the SE 555 and automated cleaning, retraction, and calibration capabilities of the Unical 9000 are ideal for sterility and consistency. Implementing automated pH and DO systems in the fermentation process for the pharmaceutical industry can provide a significant return on investment for customers.

Customer ROI

Reduced Contamination Risk: Automation reduces the need for manual interventions, decreasing the risk of contamination. A closed system maintains sterile operations more effectively, ensuring product safety.

Optimized Fermentation Conditions: Automated pH and DO systems ensure optimal conditions for microbial growth and product formation. Consistent maintenance of optimal pH and DO levels can lead to higher yields and faster production times.

Resource Efficiency: Precise control of pH and DO levels reduces the consumption of expensive reagents and raw materials. Efficient use of resources results in cost savings over time.

Optimize the Use of Personnel: Automation not only reduces the risk of human error but allows operators to delegate personnel to other crucial duties more effectively.

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Bio-Fermentation in the Pharmaceutical Industry