Lyospheres: Enabling Flexibility for Lyophilized Products

15:35 - 16:10

Currently, pharmaceutical products that are labile are lyophilized (freeze dried) to maintain their stability and potency.  Traditional lyophilized products require the liquid product to be filled into the final container prior to freeze drying, limiting the drug product to a specific formulation, target potency, and volume.  Lyospheres, which are small, freeze-dried beads that contain the active material and excipients, are dispensed into vials and potentially allow for a  more innovative and flexible approach for achieving final drug product images.  Lyospheres are first generated from a bulk drug substance batch using “straight through processing” which is independent of the bulk potency.  Following the drying process, the lyospheres are tested for potency and based on their result, titrated into the final drug product vial, minimizing overages.  In the case of vaccines, individual lyospheres may be generated from a variety of vaccine bulk drug substances and combined into a single image to form a multi-vaccine product.  This could allow new combinations of vaccine products and enable the ability to “mix and match” products.  In addition, by changing the amount of lyospheres per vial, the supply chain could have flexibility to have both single- and multi-dose images.  Another benefit of lyospheres is with regards to potentially improving thermal stability profiles for products.  By generating individual lyospheres for different components, an “optimized” formulation could be developed for each component without compromising stability of other components.  In conclusion, lyosphere technology represents a potential flexible way of making lyophilized drug products in the future.

Brian K. Meyer, Principal Scientist New Technologies, Vaccine Drug Product Development, Bioprocess Research and Development, Merck