Vaccines save millions of lives every year and improve the quality of life for countless others. Unlike monoclonal antibodies, a greater diversity of molecular size exists for vaccine products, which makes a downstream process hard to template. In the case of conjugated polysaccharide vaccines, this is further complicated by the fact that a large number of strains and serotypes need to be conjugated into a multivalent vaccine to provide thorough immunity, and each serotype can behave differently during processing. One of the most critical purification steps in a conjugated polysaccharide vaccine process is the removal of unconjugated polysaccharide from the feed stream, which is typically performed via tangential flow filtration (TFF). A continuing challenge for the TFF step is that membranes are available in a limited set of nominal molecular weight cutoffs. This limited availability of specific pore size membranes often leads to yield sacrifices in order to maintain the required purity, which potentially impacts the reliability of vaccine supply. An advancement in the mPES membrane manufacturing process can enable better uniformity and improved control of the membrane pore size. This provides the capability of producing a custom TFF membrane best suited for a given process stream and therefore, enhance yield, purity, efficiency, and economics in new or existing vaccine processes.
In this webinar, we will discuss:
- Current process development challenges for conjugate polysaccharide vaccines (CPV)
- How a custom membrane technology can be developed and implemented
- How an industrial process yield and efficiency were improved with use of custom membranes in a case study