Buffer management is a fundamental yet often neglected area of biopharmaceutical production. The demand for highly flexible multi-product systems is increasing and with it the need for appropriate media and buffer supply. Large-scale production and high-product titres due to optimised upstream processes correlate with enormous amounts of buffers needed in the downstream process. Buffer preparation can easily become a bottleneck. Innovative buffer supply strategies are more in demand than ever, not least because the conventional way of providing buffer solutions traditionally requires a large number of storage tanks, enormous space and a lot of personnel.
ZETA develops Buffer Inline Conditioning System
The Buffer Inline Conditioning System (BICS) developed by ZETA is an advanced and GMP-compliant technology for optimising buffer management. It enables on-demand production of high-quality buffers at the point of use. This innovative system integrates various processing steps – such as mixing, monitoring and adjusting the concentration of buffer solutions – into a streamlined and automated process.
ZETA’s BICS is tailored to the specific requirements of the particular production process and is seamlessly integrated into the production system with its upstream and downstream areas as an integral part of the overall production concept.
Buffer production: Traditional approach versus inline conditioning
ZETA’s BICS minimises the space required to store ready-to-use buffer solutions. This results in lower construction costs and more efficient use of building space. In addition, the on-demand provision of buffer solutions avoids overproduction and reduces waste. Time and cost savings are also achieved by streamlining operations and reducing the number of steps in buffer production. ZETA’s BICS greatly increases flexibility in process control, allowing manufacturers to quickly switch between many different buffer compositions as required.
How does the Buffer Inline Conditioning System work?
The task of the system is simple: to provide predefined buffers on demand by mixing a series of stock solutions and diluting them with water (WFI). However, the components it consists of – such as pumps, sensors and flowmeters – must be carefully selected and arranged to create a robust and flexible system that reliably delivers the required quantities of each buffer to a defined accuracy and quality.
The ZETA Buffer Inline Conditioning System is designed as a skid with all components housed in a stainless-steel frame. Mixing and metering modules ensure the consistency, homogeneity and accuracy of the buffer solutions produced. Real-time monitoring guarantees that the critical quality attributes (CQAs) are always met. The number and type of connectors are customised to the specific process requirements. They can be connected to all types and sizes of pipework: The 鈥榠nlet鈥� connections to stainless steel vessels, pipework or single-use equipment, the 鈥榦utlet鈥� connections to downstream process equipment.
Automation and connectivity
The system developed by ZETA is seamlessly integrated into the automation environment. The downstream systems (e.g. chromatography columns) communicate directly with the Buffer Inline Conditioning System and send requests for specific buffer formulations. The BICS responds by providing the buffer exactly as specified. This communication system ensures that the buffers are produced within the required specifications before they are used in the process. This results in a significant increase in accuracy and reproducibility!
A profound understanding of the process requirements is key
A thorough understanding of the biopharmaceutical production process and its requirements is key to developing an innovative buffer management strategy. Buffer compositions and their chemical components and concentrations need to be considered, as well as timing, production sequences and parallel processing steps. The aim is to ensure continuous and robust production. Production simulations using provide key insights and a solid scientific database. These are essential for the process design phase, determining equipment utilization and dimensioning process equipment and piping.
The future lies in Buffer Inline Conditioning
鈥淲e have developed an engineered product that is modular and easily scalable,” says , Corporate Head of Research and Development at ZETA, and looks to the near future: “The implementation of buffer inline conditioning systems leads to a significant reduction in the space required for production facilities. As a result, clean rooms and tank farms become smaller, leading to sustainable CAPEX and OPEX savings, and production becomes more flexible. Buffer preparation takes place in a completely closed and automated system – this means that one CNC area is sufficient for GMP-compliant buffer preparation.鈥�
Contact
Thomas Maischberger
Corporate Head of Research & Development
ZETA
thomas.maischberger@zeta.com
