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Evaluation of single-use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing |
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| Authors: | Seyed Pouria Motevalian Jonathan Steen Janine De Leon Verl Sriskanda Ivette Carino Amar S. Prashad Brenda Carrillo Conde Bo Arve |
| Affiliation: | 1. Bioprocess Research and Development, Pfizer Inc., Andover, Massachusetts, USA;2. Ultrafiltration Research and Development, MilliporeSigma, Bedford, Massachusetts, USA Contribution: Conceptualization (equal), Formal analysis (lead), Methodology (equal), Resources (equal), Supervision (equal), Validation (lead), Visualization (equal), Writing - original draft (supporting), Writing - review & editing (supporting);3. Bioprocess Research and Development, Pfizer Inc., Andover, Massachusetts, USA Contribution: Data curation (equal), Investigation (equal), Writing - original draft (supporting);4. Analytical Research and Development, Pfizer Inc., Andover, Massachusetts, USA Contribution: Data curation (equal), Formal analysis (supporting), Investigation (equal);5. Bioprocess Research and Development, Pfizer Inc., Andover, Massachusetts, USA Contribution: Data curation (equal), Investigation (equal);6. Bioprocess Research and Development, Pfizer Inc., Andover, Massachusetts, USA Contribution: Conceptualization (equal), Supervision (equal);7. Bioprocess Research and Development, Pfizer Inc., Chesterfield, Missouri, USA Contribution: Resources (equal), Supervision (equal);8. Bioprocess Research and Development, Pfizer Inc., Chesterfield, Missouri, USA Contribution: Conceptualization (equal), Supervision (equal) |
| Abstract: | Over the past decade, single-use tangential flow filtration (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. In this study, the performance of a recently developed Pellicon® single-use TFF capsule was compared against traditional Pellicon® cassettes 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. Additionally, similar TFF process performance and post-purification product attributes were observed for the single-use capsule compared to the reusable TFF cassettes. 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 conjugate vaccines. |
| Keywords: | scale up single use TFF vaccines |