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

Need Development?

Unlock the full potential of your lyophilization process with our expert guidance. Whether you need development, optimization, or a seamless transfer, we are here to give you the best product and experience possible.

Our dedicated team ensures a water-free, high-quality cake in a fast cycle time.

Semi-Automated Filling Line

Semi-Automated Vial Filling & Lyophilization

Our semi-automated isolator-based fill and lyophilize up to 3,500 10R vials. This line is ideal for clinical-scale lyo projects.

Automated Filling Line

Automated Vial Filling & Lyophilization

Our automated filling line can lyophilize up to 35,000 10R vials, and the line will be fitted with a second lyophilizer to double capacity by 2025. This line features fully robotic and automated filling in isolators to offer the greatest sterility assurance achievable.

Download our Free Guide: Navigating the Fill Finish Process

Download our free guide! This document offers an introductory overview to the fill finish process, which teams are involved, and key differences in filling environments and equipment commonly employed at CDMOs.