Removing bottlenecks in downstream processing purification

Image of monoclonal antibody (mAb) like those used in biopharmaceutical manufacturing, pink background

In the production of monoclonal antibodies (mAbs), finding ways to remove bottlenecks and improve yields in downstream processing continues to be a key focus area for biopharma manufacturers. Downstream processing generally takes place over a period of a few weeks and involves many unit operations – from multiple chromatographic steps and filtration steps, and more than a dozen buffers and cleaning solutions as part of the process. In fact, about 60-80 percent of the total cost of producing a mAb can be attributed back to downstream processing[1].

A capture step is the first purification step where protein A has become the most widely used resin due to its highly specific nature, ease of implementation as a standard purification process, and strong regulatory track record[2] . It is well known that the cost of the protein A capture step is substantial, and that buffer preparation is an area for improvement to help improve both cost and efficiency.

In this article, we will highlight strategies to improve the productivity of the capture step through the selection of a high performance protein A resin and optimization of buffer preparation. Buffer preparation will be further discussed by comparing in-house buffer preparation and ready-to-use buffers, or buffer concentrates utilizing latest technologies and supply chain options.

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Authors

Dr. Jungmin Oh

Manager, New Product Development

In her current role, Jungmin leads product and process development projects with multiple biopharmaceutical industry partners, including customized product development for cell and gene therapy customers. She holds a MS and Ph.D. in chemical engineering, specializing in the optimization of a continuous chromatography system.

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.

Dr. Jonathan Fura

Manager, Research & Development

In his current role, Jonathan focuses on developing technologies that are utilized to advance the development and manufacturing of antibody-based biopharmaceuticals and diagnostics. Jonathan holds a Ph.D. in chemistry with a focus on developing immunomodulation therapeutic strategies.

Dr. Nandu Deorkar

Vice President, Research & Development – Biopharma Production

During his more than 25-year career in materials technology research & development, Dr Deorkar has worked on various aspects of chemical/polymer R&D, drug development, formulation, drug delivery technologies, process development, and technology transfer. Dr Deorkar earned his PhD in chemistry from the Indian Institute of Technology, Bombay, and his MBA from Fairleigh Dickinson University, New Jersey (USA).

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