The utilization of Pall’s patented single-pass TFF (SPTFF) technologies is a key enabler of continuous bioprocessing initiatives. The integration and optimization of a prototype inline diafiltration (ILDF) module with the Cadence™ inline concentrator (ILC) with sterile filtration is key to development of a fully continuous, streamlined final formulation process platform. Coupling this continuous final formulation processes allows for further optimization and reduction of module/device flushing as well as reduction of in-process buffer consumption compared to independent operation. The implementation of this continuous final formulation train (ILDF/ILC/0.2µm) successfully achieved &gt; 3-log (&gt; 99.9%) primary buffer species impurity removal and ≥ 20x concentration factor while delivering a 0.2µm filtered monoclonal antibody. Such simplified process flow with a single concentration and diafiltration step could be of great value to low-to-mid-range formulation targets and subsequent delivery strategies. In addition to intravenous administration applications [1], low-to-mid range concentrations deliver a decreased glide force in subcutaneous injections, lowering site pain and increasing patient compliance [2]. References [1] Shire, S. (2015). Challenges in the intravenous (IV) administration of monoclonal antibodies (mAbs). In Monoclonal Antibodies (pp 121-127). Waltham, MA: Woodhead Publishing. [2] Goswami, S.; Wang, W.; Arakawa, T.; Ohtake, S. Developments and Challenges for mAb-Based Therapeutics. Antibodies 2013, 2, 452-500.

Optimization and integration of single-pass, continuous final formulation technologies for mAb purification

253rd National Meeting (2017)

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