Highly effective vaccines against diseases caused by N. meningitidis, S. pneumoniae, and H. influenza can be produced by chemical conjugation of the capsular polysaccharide from these bacteria to an immunogenic protein such as tetanus toxoid, CRM197 or diphtheria toxoid. The conjugation process typically involves a polysaccharide activation step in preparation for covalent linkage to the immunogenic protein. Tangential Flow Filtration (TFF) is widely used for buffer exchange and purification of activated and conjugated polysaccharides against reaction byproducts or residuals. Over the past decade, single-use TFF technologies have emerged to reduce system preparation time, promote fast and flexible product change over, and ultimately shorten process development and manufacturing time/cost. The primary objective of this work was to evaluate a novel, gamma-sterilized Pellicon® single-use TFF capsule against traditional reusable Pellicon® cassettes with respect to performance, flush requirement, product recovery, and ease-of-use; whereas the secondary objective was to assess the scalability of Pellicon® TFF cassettes and capsule for the purification of activated polysaccharides. In particular, the performance of a recently developed Pellicon® single-use TFF capsule was compared against the traditional Pellicon® cassette by assessing TFF process performance (such as flux, residuals clearance, and yield) and post-purification product attributes (such as concentration and mass-weighted average molecular weight). Good scaling was shown by comparing process performance and product attributes across different scales and formats (88 cm2 vs 1100 cm2 cassettes and 1000 cm2 capsule). Similar TFF process performance and post-purification product attributes were observed for the single-use capsule compared to the reusable TFF cassettes. In addition, the capsule requires a smaller flush than the cassette, and it is easier to use since it does not require a compression holder or pre-sanitization. The results provide insight into the application of the single-use TFF capsule and scalability of TFF processes for the purification of activated polysaccharides used in conjugate vaccine manufacturing.

Evaluation of single-use TFF Technology for purification of activated polysaccharides used in conjugate vaccine manufacturing

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.