Proven
Proven expertise in lyophilization for biologics and sterile products
Lyophilization Cycle Development
We design robust, scalable lyophilization cycles for biologics, sterile injectables, and temperature-sensitive formulations, carefully balancing product quality, stability, and process efficiency to support reliable clinical development and successful commercial outcomes.
Lyophilization meets scale
We specialize in designing and optimizing lyophilization cycles tailored to your product, whether building a new process or enhancing an existing one. With one of the industry’s largest, fully scalable lyophilization capacities, we support everything from early development through commercial production.
Core capabilities
Supported by one of the industry's largest and fully scalable lyophilization capacities, our expertise spans early development through commercial production, enabling reliable scale-up, consistent performance, and confident delivery at every stage.
- End-to-End Cycle Development
- Thermal Characterization
- Freeze-Drying Microscopy
- Intentional Collapse Studies (ICS)
- Small-Scale Development
- Lyophilization Cycle Optimization
- Toxicology Batch Production
- Solvent-Based Lyophilization
Data-led lyophilization
Understanding your formulation’s thermal profile is the foundation of an effective lyophilization cycle. We apply modulated differential scanning calorimetry (mDSC) to define key thermal parameters, including glass transition (Tg’), eutectic temperature (Te), collapse temperature (Tc), and re-crystallization temperature (Tcry). Complementing this, freeze-drying microscopy (FDM) provides visual confirmation that strengthens the thermal analysis and helps optimize primary and secondary drying conditions.
To ensure product quality and process robustness, we conduct Intentional Collapse Studies during final development. These controlled stress tests help quantify the limits of your formulation, identify potential failure points, and refine cycle parameters. The result is a more resilient process that allows your product to consistently meet its Critical Quality Attributes (CQAs) at release.
When material availability is limited, we design tailored development plans that use placebos or minimal API during early feasibility and apply scalable methods for final confirmatory runs. This approach conserves valuable drug substance while maintaining full scientific rigor.
Cycle optimization
We fine-tune each cycle to achieve low residual moisture, optimal cake structure and appearance, efficient and reliable reconstitution, and reduced total cycle time. By optimizing these critical attributes, we deliver a cost-effective, scalable process that supports consistent performance throughout your product’s lifecycle.
Complex processes controlled
As part of your preclinical development, we will manufacture toxicology batches under either non-GMP or GMP conditions to support IND-enabling studies. Our approach ensures representative material, appropriate controls, and robust documentation, giving you the data package and confidence needed to advance toward first-in-human evaluation.
For processes involving organic solvents, we provide safe, compliant solutions using tert-butyl alcohol, acetonitrile, DMSO, or ethanol. Working closely with our Environmental Health & Safety (EHS) teams, we manage solvent use safely and efficiently within our GMP facilities.
We are inspired by tomorrow
Scalable
Scalable capacity from early development through commercial launch
Integrated
Integrated services across formulation, analytical development, manufacturing, and packaging
Global
Global network with centres of excellence and advanced facilities in North America and Europe
Sterile Development & Manufacturing
Evolution from tech-transfer to treatment, where intelligence, technology, and scalability meet quality, safety, and speed to market
Learn more about our sterile capabilities that deliver quality, innovation, and reliability from development through commercialization.
Contact us today to talk to our expert customer services team about how we can support you with lyophilization cycle development services.