Lyophilization Development

Lyophilization Development

Some drug products are too sensitive to remain in solution. Not only do our filling lines support lyophilization, but we can help develop your lyo cycle. We provide lyophilization optimization, scale-up services, and tech transfer. We use differential scanning calorimetry (DSC) and freeze dry microscopy (FDM) to understand critical product temperatures and to develop and optimize your cycle and cake quality.

We have both a clinical-scale and commercial scale lyophilizer, capable of filling up to 3,500 10R vials and 35,000 10R vials respectively. We can develop your lyophilization formulation, lyo cycles based on thermal properties, and scale-up the lyo process when you move on in your clinical trials, and we also offer the unique ability to handle the development through commercialization to finalize your process for a successful commercial presentation.

Development Services:

  • Lyo cycle development & optimization
  • Cake quality optimization

Container Sizes:

  • All lyos are equipped for 2R, 6R, 10R, and 20R vials
  • All lyos capable of processing 50R and 100R vials

Lyophilizers:

  • Two lab-scale IMA lyophilizers for development
  • A Clinical-scale IMA Lyolizer affixed to BSM’s semi-automated filling line (approx. 3,000 10R vials/batch)
  • One IMA Lyomax Industrial lyophilizer affixed to BSM’s fully automated filling line (approx. 30,000 10R vials/batch)

Upcoming Webinar:

Wednesday, October 19th | 1PM EST

Reducing loss in fill finish for high-value drug products