Evaluation of single‐use tangential flow filtration technology for purification of activated polysaccharides used in conjugate vaccine manufacturing

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.

Microparticle RSV Vaccines Presenting the G Protein CX3C Chemokine Motif in the Context of TLR Signaling Induce Protective Th1 Immune Responses and Prevent Pulmonary Eosinophilia Post-Challenge

“…DP sequences are detailed in Table 1. LbL-MP were fabricated as previously described by alternately layering poly-l-glutamic acid (PGA, negative charge) and poly-l-lysine (PLL, positive charge) on 3 µm diameter CaCO 3 cores to build up a seven-layer base film prior to addition of DP [41]; layering was accomplished manually by centrifugation or in an automated process using tangential flow filtration, a scalable process that is used in the biopharmaceutical industry for the purification of numerous biomolecules [42,43]. All LbL-MP passed the following release specifications before being used in the reported studies: DP content by amino acid analysis (>200 µg/mL bulk, or >133 pg/particle); endotoxin levels by limulus amebocyte assay or recombinant factor C assay (<0.1 EU/µg DP); and size dispersity by dynamic light scattering (<10 µm diameter).…”