Lyophilization

Lyophilization

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.

Lyophilization Details:

  • Container Sizes: Client Directed
  • Capacity: Client Directed – up to 35,000 10 mL vials
  • Operations: Manual, Semi-Automated, or Automated – all
  • Components: Client Specified
  • Fully isolated filling environments
  • Lyo development and optimization services
Filling LineScaleVial Size
Semi-Automated LineClinical up to 3,500 10R2 mL - 100 mL
Automated LineClinical or Commercial up to 35,000 10R2 mL - 100 mL

Upcoming Webinar:

Wednesday, October 19th | 1PM EST

Reducing loss in fill finish for high-value drug products