Legacy Pharmaceuticals, a global contract manufacturer of sterile/aseptic pharmaceutical products in ampoules and vials, has unveiled their long-term expansion strategy to address the global growth in demand for lyophilization in vials. The 5-year plan builds on Legacy’s existing core fill-finish competencies in lyophilization, and liquid and powder vials. As a first step Legacy has already started a project to add customized lyophilization in vials for an ongoing customer project, with an anticipated start date of mid-2020.
 
Lyophilization in vials is a trend in the industry that continues to grow due to the increase of biologicals. Already the share of injectable/infusible lyophilized 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.
 
“By 2020, global pharma companies estimate lyophilized drugs will represent 30-40% of their pipeline,” said Mike Danzi, chief executive officer, Legacy Pharmaceuticals. “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.”
 
Legacy is planning to build a lyophilization suite with closed RABS filling line technology, 2 to 3 freeze-driers up to 30 square meters in scale each and automated load and unloading systems. Construction will take 24-30 months.
 
“We are now looking to open discussions with existing and new customers interested to retain capacity in this strategic project,” said Mr. Danzi.