Integrated
Integrated sterile development and manufacturing services spanning formulation, process development, scale-up, and commercial production within a single, coordinated network.
Sterile Manufacturing
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.
Engineering the future
With more than 25 years of sterile fill–finish and lyophilization expertise, we provide integrated development and manufacturing solutions for complex sterile injectables. Our global capabilities support small- and large-molecule products from early clinical phases through commercial supply.
Core capabilities
We specialize in a broad range of formulation types, from nanoparticles and mRNA to monoclonal antibodies (mAbs), proteins and peptides, oligonucleotides, and other biologics and highly potent compounds. We support these products across multiple sterile delivery formats, including vials and bottles, prefilled syringes (PFS), autoinjectors, pens, and on-body delivery systems.
- Pre-filled syringes & Advanced delivery formats
- Sterile drug product development
- Sterile manufacturing & Fill-finish
- GMP analytical testing
Precision that protects
Our fill-finish operations meet the highest standards of quality and sterility, ensuring product safety and regulatory compliance and delivering key advantages, including enhanced sterility and reduced contamination risk, accurate pre-measured dosing for improved safety, greater ease of use for healthcare providers and patients, suitability for self-administration and at-home care, and reduced drug waste with improved product integrity.
Every step. Sterility.
Our formulation development uses a Quality by Design (QbD) approach to deliver robust, scalable, and commercially viable processes for sterile drug products, featuring optimization for all parenteral routes of administration, solutions to solubility and stability challenges, custom lyophilization cycle development to support product stability and shelf-life, and seamless scale-up from clinical to commercial production.
We deliver high-performance sterile manufacturing solutions with the infrastructure and expertise to manage even the most complex products, including aseptic fill-finish for multiple dosage forms, specialized handling of biologics and highly potent compounds, clinical-to-commercial scale production, and regulatory expertise across global markets.
Our in-house GMP analytical laboratories streamline your supply chain and accelerate timelines through efficient method development and testing, including product-specific method development and validation, method transfer and optimization, stability testing and release analytics, and full compliance with global regulatory standards.
We are inspired by tomorrow
Capacity
Global capacity across North America and Europe, enabling flexible scale, regional supply strategies, and reliable support from early development through commercial launch.
Proven
A proven track record in supporting complex, high-value therapies, backed by deep technical expertise, regulatory experience, and consistent delivery for critical patient needs.
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 drug manufacturing services.