How Buffer Prep Alleviates Rising Pressure

September 21, 2022

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Buffer preparation is often seen as the ‘forgotten procedure’ in a bioprocessing platform, yet it is one of the most resource intensive and demanding activities, and one which can cause serious bottlenecks leading to delays, and any errors having a critical impact on the batch. Yet it doesn’t have to be like this.

 

Buffer plays a major role throughout a typical processes, ranging across multiple product recovery, purification, titration and formulation steps such as diafiltration and formulation . So, integrating an efficient process when it comes to buffer preparation and supply is paramount. Process buffers play a dual role, both protecting proteins from possible fluctuations in pH and being critical to the performance and effectiveness of unit operations such as chromatographic purification.

 

The demand for product is increasing and facilities are being asked to produce more with less. This leads to a need to streamline processes and make best use of available space. Traditional buffer preparation, storage and supply is a logistical challenge often managed by ensuring buffer stocks are available well in advance, often a week before being required to ensure availability and the necessary QC testing. Yet, by making this in advance, this adds significant storage pressures often resulting in buffers being stored in corridors and other awkward locations. This challenge is amplified by facilities that make several different products at one time and for clinical-scale processes where more than 10,000 L of buffers per batch are common.

 

Producing such vast amounts of buffer also presents health and safety risks. The preparation of large volumes takes a significant amount of labor and the weight of ready-made buffer presents a risk to staff moving the buffer from storage to production. For facilities utilizing single-use technology this carries a burden of a large number of consumables and for processes still leveraging reusable vessels and mixing, the cleaning, cleaning validation and equipment preparation present significant logistical, operator resource and space burdens.

 

There are multiple solutions to the challenge depending upon the specific facility needs and preferences. These range from outsourcing buffer supply to in-line buffer conditioning to make buffers on demand from stock solutions of acids, bases and salts using an automated process.  Options also include simply adopting single-use preparation and mixing solutions and in-line buffer dilution minimizing preparation and storage volumes via concentrated stock buffers.

 

Implementing a flexible, automated buffer management system can significantly reduce these pressures and balance the benefits of automation with the need for process flexibility. Systems that can provide ‘just in time’ process buffers, direct to multiple unit operations simultaneously can significantly improve the entire process buffer workflow.

 

When compared to traditional buffer supply methods, in-line dilution from buffer concentrates, can deliver significant floor space savings, automating the process also reduces labor costs and releases resources for more value adding processes. Such systems also reduce single-use consumables and ultimately reduce the cost of buffer production.

 

Taking action to alleviate buffer supply pressure provides many benefits in a bioprocessing platform. It can simplify buffer preparation, storage, and supply logistics. In turn it saves you money, time, and, through automation and control, provides a safer method of supplying your platform with the buffer needed. Compliance is simplified and, with full traceability and batch reporting, flexible automation integrates with your process today and safeguards compatibility as your process evolves.

 

 

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