A Customer-Centric, Outcomes-Focused Partner

Unilife serves the long-term requirements of pharmaceutical companies under value-adding relationships for high-quality drug-device combination products. We have brought together a market-leading combination of products, partners and people within a customer-centric business structure to minimize risk and maximize opportunities for you to enhance patient care and differentiate your therapies from the competition. In addition to retaining proprietary ownership of our technologies and related processes, we maintain overall responsibility for the entire drug delivery system that we develop and manufacture for supply to you for filling and final packaging with target biologics.

Innovation

We have forged an unparalleled reputation for the creation of innovative technological solutions that fit within a standard industry footprint. Every product that we create addresses critical, unmet customer and market needs, and represents a paradigm shift within its device segment. To minimize customer risk or disruption to their normal processes, our products also leverage well-characterized component materials sourced from well-known suppliers and are designed for seamless integration with standard filling and packaging systems.

Customization

All product configurations across our portfolio of platform-based technologies are based upon a modular system that is designed to allow the customization of one element without creating a need to redesign the others. This provides customers with a modern, flexible and easily scalable technology platform that can be efficiently tailored to specific drug, patient or brand requirements with minimum risk or incremental cost. In addition to standard customization options relating to size, look, shape and materials, a number of advanced customization options are available within each category.

Industrialization

Our primary drug containers are designed with industry standard borosilicate type 1 glass and well characterized lubrication oils and elastomers for long-term drug containment integrity and sterility assurance. We work with our customers to source component materials and sub-assembly components from preferred industry suppliers. Products are also designed for seamless integration with standard filling and final packaging processes and equipment.  

Quality and Regulatory

We are an FDA-registered medical device manufacturer with a Quality Management System that is compliant to ISO 13485, 21 CFR 210/211 and 21CFR820 and has been successfully audited by regulatory agencies, notified bodies, independent consultants and various pharmaceutical companies. To support the production, supply and use of high-quality products, we adhere to stringent procedures for identification and traceability, calibration and maintenance, product acceptance, labeling, packaging, and records control. Our team has significant experience in regulatory submissions including 510(k) and Device Master Files.

Production and Supply

Our business is structured to provide pharmaceutical customers with long-term continuity for production and supply to minimize risk and maximize choice during the clinical development, approval and commercial marketing of the drug-device combination. Partnerships are in place with a range of global industry leaders that are regularly utilized by pharmaceutical companies for contract manufacturing, elastomers, glass tubing, injection molding, equipment automation, contract filling, electronics and sterilization.

Technical and Filling Support

We provide customers with broad access to the deep scientific knowledge of our project teams and associated technical services across areas including compatibility and stability testing, fill-finish line validation, human factor studies, formulation modeling, regulatory submission and clinical study plans. Support is available for small or large scale filling operations including filling, stoppering, inspection, material handling and process validation. We also provide access to industry leading CMOs and filling equipment manufacturers.