Fast and Furious: Cell-Free Biomanufacturing Approaches

Prevailing biologics manufacturing technologies are ill-suited to rapidly respond to biothreats and/or rapid fluctuations in product demand. A typical manufacturing campaign starting from a cell bank to a finished vial can take several weeks, during which time enormous casualties may be sustained. In addition, distribution logistics during a time of potential travel restrictions and quarantines would result in additional barriers to delivering the therapeutic/vaccine in a timely fashion.

We propose that these limitations can be overcome using cell-free biomanufacturing. Case studies will be presented for a rapid response to a radiological incident, where large quantities of GCSF will need to be therapeutically administered. Currently, GCSF is stored in the Strategic National Stockpile, but faces constant expiration and replenishment requirements. In contrast, we show how a cell-free approach can be used to overcome these limitations.

Other biologics/vaccine candidates, scale-up possibilities and regulatory barriers will be discussed.