Aqueous Two-Phase Extraction

Aqueous two-phase extraction (ATPE) is a bio-friendly method to purify viral particles. The method has a large amount of variables that need to be controlled, making it incompatible with the currently tight process development timelines. We are working to understand some of the key variables in ATPE so that it can be implemented in viral manufacturing processes.

Continuous Manufacturing

Another reason to study ATPE is that it is extremely amenable to continuous manufacturing. Continuous viral therapy manufacturing could speed the time to market and also make processes more versatile to manufacture more than one type of viral therapy at each facility. We have shown that continuous manufacturing can give the same results as batch, allowing for a transition to continuous viral therapy manufacturing using ATPE.

Interaction of Osmolytes with Viral Particles

We are interested in how osmolytes interact with viral particles. Osmolytes are often used in protein therapeutic formulation to stabilize proteins. This most likely occurs because the protein dehydrates and then compacts. The entropic loss of compaction is compensated by the enthalpic loss of water binding. This balance is different for viruses because they are rigid and cannot take a loss in entropy to compact. We have found that viruses can flocculate in the presence of osmolytes. We are also looking at how osmolytes can modulate ATPE.