Compliance
A proven regulatory track record, with extensive experience supporting global submissions and maintaining compliance across FDA, EMA, and other international regulatory frameworks.
Sterile Fill-Finish & Lyophilization
We support the full product lifecycle with 14 automated fill-finish lines that seamlessly scale across sterile dosage forms, including vials, cartridges, prefilled syringes, and autoinjectors, delivering flexible batch sizes and configurations from early development through commercial supply.
Flexible. Proven.
Partner with us for industry-leading sterile fill-finish and lyophilization, supported by a flexible manufacturing platform and proven regulatory success, ensuring efficient, high-quality drug product delivery while minimizing loss, maximizing yield, and accelerating your path to market.
Formulation and temperature control
All formulation processes are in controlled ISO 7/Grade C environments, where we tailor the approach to your molecule's specific needs using glass carboys, stainless-steel vessels, or single-use biobags. For heat-sensitive products or APIs, we provide advanced thermal control to maintain product stability and temperatures between 2°C and 50°C during formulation and filling, using temperature-control units and jacketed vessels.
Precision all the way
We specialize in aseptic processing for complex and novel drug products, including polymer and lipid nanoparticles. When a product cannot be terminally sterilized or sterile filtered, our ISO 5 formulation suites enable the development and qualification of a fully aseptic process.
Our in-house analytical experts support smooth, compliant method development and optimization, method transfer, and method qualification and validation, providing integrated oversight that mitigates risk and safeguards quality at every stage of your product's journey.
We complete our end-to-end offering with robust packaging and device assembly capabilities, including custom packaging design and development, drug-device assembly and testing, and advanced injectable packaging solutions. Delivering flexible, innovative options for both conventional and specialty injectable products, we ensure patient needs are at the center of every package.
We are inspired by tomorrow
Scalability
Scalable, flexible infrastructure designed to adapt seamlessly from clinical development through commercial production, supporting changing volumes, formats, and market needs.
Expertise
Deep expertise in sterile manufacturing, built on decades of technical know-how, specialized facilities, and rigorous process control for complex and high-value therapies.
Integrity
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 sterile fill-finish & lyophilization services.