A lyophilisation suite is in the works, with closed RABS filling line technology, 2 to 3 freeze-driers up to 30 sqm each and automated load and unloading systems
Legacy Pharmaceuticals have announced a long-term expansion strategy to address the global growth in demand for lyophilisation in vials. The 5-year plan builds on Legacy’s existing core fill finish competencies in lyophilisation, and liquid and powder vials.
As a first step, the CMO of sterile/aseptic pharmaceutical products in ampoules and vials, has already started a project to add customised lyophilisation in vials for an ongoing customer project, with an anticipated start date of mid-2020.
Mike Danzi, CEO of Legacy Pharmaceuticals, explained that Legacy is also planning to build a lyophilisation suite with closed RABS filling line technology, 2 to 3 freeze-driers up to 30 sqm each and automated load and unloading systems.
Lyophilisation in vials is a trend in the industry that continues to grow due to the increase of biologicals. Already the share of injectable/infusible lyophilised drugs approved has risen from 11.9% in 1999 to over 50% and is still predicted to increase. Main product types include cell and cell-based therapies, small molecule drugs, diagnostics and biologics, including peptides, recombinant proteins and vaccines.
Danzi said: “By 2020, global pharma companies estimate lyophilised drugs will represent 30-40% of their pipeline. However, the manufacturing capacity our industry needs does not exist at the moment, and it cannot be built overnight. Decisions need to be taken now, which is why we are announcing this expansion strategy and committing to increasing our capacity.”
The company estimates the construction timeframe will be about 24-30 months and are now looking to open discussions with existing and new customers interested to retain capacity in this strategic project.