When biopharmaceutical innovation meets the demand for sustainability, single-use membrane chromatography emerges as a game-changing solution in the quest for efficient and eco-friendly bioprocessing. At Bora Biologics, our Purification Process Development team is harnessing single-use membrane chromatography to innovate downstream processing.

We have recently evaluated affinity and anion exchange (AEX) membrane chromatography as viable alternatives to traditional packed-bed column chromatography. These membrane technologies offer significant advantages in process speed, facility flexibility, and sustainability.

Affinity membrane chromatography has demonstrated excellent recovery and effective host cell protein (HCP) reduction. Its capacity to operate at extremely high flow rates makes it ideal for high-throughput purification, significantly reducing processing times—making it a compelling option for small to mid-scale protein purification. However, scaling up membrane-based Protein A chromatography to manufacturing scale necessitates careful consideration of yield and buffer consumption to ensure operational feasibility.

Among the AEX membranes evaluated, one showed remarkable performance, achieving a 10–15-fold increase in productivity and over a 40-fold reduction in process time compared to conventional Q columns. While it requires approximately five-fold higher buffer volumes, this can be effectively managed through concentrated buffer strategies. The trade-off between speed and simplicity positions it as a strong candidate for high-throughput workflows and single-use applications.

As we further explore membrane chromatography across varying process scales and formats, we see significant potential for platform-specific implementations that enhance operational agility and promote sustainable manufacturing.

One of the standout benefits of membrane chromatography is its alignment with sustainable manufacturing principles. The single-use format minimizes the need for cleaning validation, reduces water and chemical consumption, and simplifies setup and changeover, making it especially advantageous for multiproduct facilities and rapid development pipelines.

As we optimize and expand our membrane platform, we remain committed to delivering faster, greener, and more flexible purification strategies to support the next generation of biologics.

About the Author
Lynn Hsiao is a Lead Scientist at Bora Biologics, bringing over 10 years of experience in protein purification and CMC development. Since joining the company in 2013, Lynn has built an extensive track record in purification process development, viral clearance studies, and technical transfer from R&D to CDMO settings. Having managed more than 10 purification projects, Lynn has successfully delivered Phase I clinical materials and supported numerous regulatory submissions. Her expertise encompasses chromatographic operations, process optimization, and interdepartmental collaboration, along with a strong ability to coordinate CRO partnerships for viral clearance. Lynn holds a Master’s degree and is a certified Project Management Professional (PMP), equipping her with the skills to drive projects effectively and ensure quality outcomes in the biopharmaceutical sector.