Experience
25+ years of proven lyophilization expertise
Bulk Lyophilization
Our expertise extends to potent compounds and solvent-based formulations, all delivered with a steadfast commitment to GMP-quality standards and EHS best practices.
Trust in experience
With more than 25 years of experience, we're a trusted leader in large-scale bulk lyophilization, expertly managing the freeze-drying, harvesting, and packaging of medical devices, drug intermediates, and APIs.
We offer global scalability with flexible capacity to support projects of any size, accelerating timelines through optimized lyophilization cycles and providing fully integrated solutions from freeze-drying to fill-finish and final packaging.
Capacity
Global scalability with flexible capacity to support projects of any size
Efficiency
Accelerated project timelines through optimized lyophilization cycles
Continuity
Integrated solutions from freeze-drying to fill-finish and final packaging
Precision at scale
We offer flexible capacity across our global sites, from small-scale trays to lyophilizers accommodating up to 195 disposable Lyoguard® trays (260 ft²), with a proven ability to optimize and shorten lyophilization cycles for greater efficiency.
We ensure seamless transfer of bulk freeze-dried products or direct fill-finish into vials, prefilled syringes, or dropper bottles, eliminating complex tech transfers, while also providing pouch packaging for freeze-dried trays and custom harvesting solutions, including containment for potent compounds.
We bring deep expertise in handling organic solvent formulations, such as tert-butyl alcohol, acetonitrile, DMSO, and ethanol, supported by GMP-compliant process development and transfer, and close collaboration with Environmental Health and Safety teams to ensure safe, compliant solvent management.
We are inspired by tomorrow
Compliance
A proven regulatory track record, with extensive experience supporting global submissions and maintaining compliance across FDA, EMA, and other international regulatory frameworks.
Seamless
Scalable, flexible infrastructure designed to adapt seamlessly from clinical development through commercial production, supporting changing volumes, formats, and market needs.
Specialized
Deep expertise in sterile manufacturing, built on decades of technical know-how, specialized facilities, and rigorous process control for complex and high-value therapies.
Quality
A steadfast commitment to quality and patient-centricity, ensuring every decision, process, and product is guided by safety, reliability, and the ultimate impact on patients’ lives.
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 bulk lyophilization services.