How to Reduce Buffer Consumption in the Downstream Purification of Monoclonal Antibodies
In this article, we analyze the growing industry need to reduce buffer consumption in the purification of proteins and monoclonal antibodies in order to make processes more efficient and capable of reducing the bottleneck in downstream processing.
Significance of buffers in downstream processing
Buffers are an important component of downstream processing. They are responsible for maintaining purification conditions, governing a protein’s state required for chromatography and stabilizing a protein whilst preserving its functional features. In downstream processing, they are especially important in protecting proteins from pH variations.
Buffers can feature in different stages of the purification process, including protein capture, polishing and filtration. They make up the largest element by volume in the downstream processing of biopharmaceuticals.
In upstream processing, developments have made it much easier to acquire higher titers using the same facilities and equipment. But this increase in titers is placing more strain on downstream purification steps, resulting in the need for higher capacity buffer and resin.
Selecting a buffer
There are important characteristics to consider when selecting a buffer. The function and configuration of the solution must be tailored to the specific stage of your purification process. A single purification stage may require multiple buffers with each buffer requiring a dedicated composition.
Why reducing buffer consumption is important
In the manufacturing of protein-based pharmaceuticals, the buffer solutions required to purify continually increasing upstream titers have a very low pH, resulting in a more concentrated elution pool for improved resin capacity in order to meet the demands of processing. This has, however, highlighted the operational challenges for biopharmaceutical companies in the preparation and storage of these large quantities of buffer solutions, and now, the industry is emphasizing the need to reduce the facility footprint and labour involved in maintaining the buffers, whilst significantly reducing their manufacturing costs. Making steps to improve this part of the process is imperative to reducing the bottleneck on downstream processing.
What are the requirements for reduced buffer consumption?
High capacity resins are vital to the purification process as they allow for better yield within the same manufacturing footprint, removing the need for increased buffer storage. The more you are able to utilize the full capacity of your Protein A resin, the more productive your process will be.
How SMART Cycling can help you
In order to assist our partners in reducing key bottlenecks associated with the downstream processing of monoclonal antibodies, we developed the Praesto® SMART cycling model.
SMART cycling is designed to be flexible, offering different process models which each address key pain points for our customers – productivity, cost efficiency and time in facility.
It incorporates a unique, ultra-high capacity Protein A resin, Praesto Jetted A50, and demonstrates how making minor adjustments to your existing process can have major, positive impacts on key parameters in your process.
Click here to view the different process models in full, complete with data tables.
Whatever your goal, contact us today for fast, reliable advice from our mAb purification specialists.