Alternative buffer management strategies to achieve downstream process improvements

There has been significant change across the biomanufacturing industry over the last couple of decades, as increased complexity of biologics and a growing focus on smaller patient populations have led to a greater need for cost control and process efficiency.

As productivity has improved as a result, so too have titers and other areas of process development. These advancements in science and technology offer exciting promise in drug development; however, they also create challenges for those still utilizing legacy processes and systems.

For example, while buffer preparation and management can be carried out in multiple ways, an established approach is to manufacture buffers in house with the use of water-for-Injection (WFI) to hydrate powders in stainless-steel or single-use tanks. Although this method is established and ideal for large volumes, it requires significant infrastructure, including the footprint needed for large tanks and for warehouse space for holding as well as weighing and dispensing areas for raw materials.

There are other approaches to this critical bioprocessing step, although each call on capabilities and expertise that may not exist at some companies and/or are difficult to obtain. Understanding not only the alternative buffer management strategies available but also what resources are needed to execute them can help ensure you have the tools necessary to remain competitive in today’s growing bioprocessing industry.

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Author

Dr. Pranav Vengsarkar

Manager, Research & Development – Biopharma Production

Pranav Vengsarkar, Ph.D., is Manager, Process Development at Avantor, focused on product and process development for new cGMP products and excipients, and development and design of single-use raw material delivery systems. Pranav holds a Bachelor of Chemical Engineering degree from ICT, Mumbai and a Ph.D. in Chemical Engineering from Auburn University.

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Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.