Some products are simply too sensitive and require lyophilization to maintain appropriate shelf-life and efficacy for their intended patient. BSM has a clean-in-place, steam-in-place lyo. We also have experience with lyophilizing products within a syringe which can reduce costly waste from hold-up volumes. All filling operations and transfer to the lyo are performed in permanently connected isolators.
In early 2022, we will be adding a third filling line that will increase our lyophilization capability to 35,000 10R vials.
| Filling Line | Scale | Vial Size |
|---|---|---|
| Semi-Automated Line | Clinical up to 3,500 10R | 2 mL - 100 mL |
| Automated Line | Clinical or Commercial up to 35,000 10R | 2 mL - 100 mL |
