Capabilities
CAPABILITIES
What We Do
LyoVial supports your product from first feasibility run through pilot-scale delivery. Each stage is documented so it can transfer cleanly to your own operation or to your next-stage manufacturer.
Formulation & Lyo Cycle Development
We work from your existing liquid formulation, or help develop one, and design a freeze-drying cycle around it. This includes excipient and cryoprotectant selection, freezing and drying parameter development, and characterization of the dried cake.
- Formulation review and excipient selection
- Freeze-thaw and thermal characterization
- Cycle design: freezing, primary drying, secondary drying
- Small feasibility runs to confirm cake appearance, reconstitution, and stability before committing to a locked process
Scale-Up & Technology Transfer
Once a cycle is set at feasibility scale, we scale it to pilot batch size. Every parameter is documented as it moves from a handful of vials to a full pilot run, so the process transfers cleanly to your own production line or to a larger manufacturer later.
- Process parameter documentation at each scale
- Batch records suitable for technology transfer
- Support through the transition from feasibility to pilot batch
Pilot-Batch Vial Lyophilization
Production in glass vials, sized for R&D use, product launches, validation studies, and early commercial supply. We are set up for small and mid-size pilot runs, not large-scale commercial manufacturing.
- Glass vial formats to suit your product
- Batch sizes suited to R&D, launch, and validation quantities
- Consistent, documented process from run to run
A Note on Scale
We intentionally stay at the pilot batch level. If your project has outgrown pilot-scale production, we can still support formulation and cycle development, and we'll help you think through what a scale-up partner will need from that work.