The pharmaceutical industry is witnessing unprecedented demand for sterile injectable products, particularly those with complex formulations and specialized delivery requirements. As molecules become more sophisticated and viscosities climb, the need for CDMOs with deep technical expertise and flexible capabilities has never been greater.
Lifecore Injectables CDMO has built its reputation by tackling the challenges others can’t or won’t take on. As a U.S.-based Contract Development and Manufacturing Organization with a 40+ year quality and regulatory track record, Lifecore specializes in the development, fill/finish, and commercialization of sterile injectables across the full product lifecycle, from pre-clinical through commercial stages.
A Partner for Straightforward to Highly Complex Formulations
What sets Lifecore Injectables apart is its willingness to engage with complexity head-on. With more than 20 commercial products in its portfolio, the company provides comprehensive end-to-end services for organizations of all sizes. Whether a client needs support for a straightforward formulation or faces technical challenges involving highly viscous products exceeding 100,000 centipoise, Lifecore’s team approaches each project with creative problem-solving and collaborative partnership.
The company’s process development and fill/finish capabilities span syringes, vials, and cartridges. Lifecore’s proven quality management system supports a diverse range of product types, including drugs, biologics, medical devices, and combination products, providing clients with a single partner capable of navigating complex regulatory pathways.
Flexibility Where It Matters Most
One of Lifecore Injectables’ defining characteristics is its flexibility in onboarding customer processes, methods, and equipment. Rather than forcing products into rigid manufacturing frameworks, the company works collaboratively to accommodate unique requirements and solve technical challenges as they arise.
Supporting this flexibility is extensive on-site testing infrastructure, including microbiological, analytical, and physical testing capabilities with redundant laboratories. The company also conducts ICH-compliant stability studies and offers a range of labeling, packaging, and serialization options to meet diverse market requirements.
Leadership in Pharmaceutical-Grade Sodium Hyaluronate
Beyond injectable fill/finish services, Lifecore is recognized as a leading producer of pharmaceutical-grade, non-animal-sourced sodium hyaluronate. Used as both an active pharmaceutical ingredient and excipient, Lifecore’s sodium hyaluronate portfolio includes research-grade and pharmaceutical-grade materials, hydrogels, and custom modifications backed by U.S. DMF approval, EP certification, and JP compliance.
Core Capabilities at a Glance
- Process development, fill, and finish of sterile injectables for syringes, vials, and cartridges
- Deep experience with precise process control for parameters such as shear, light, oxygen, and reaction timing.
- Specialized expertise in sterile filtration and filling of highly viscous formulations (exceeding 100,000 cP)
- Proven quality management system supporting drugs, biologics, medical devices, and combination products
- Flexible onboarding of customer processes, methods, and equipment
- Comprehensive on-site testing with redundant laboratory infrastructure
A Philosophy of Partnership
Lifecore Injectables’ corporate message “Bring it” reflects a genuine commitment to taking on the difficult manufacturing challenges that define modern injectable development.
“We recently introduced our new corporate message of ‘Bring it’ to highlight our attitude and expertise on complex products and processes. Virtually all injectables involve some level of complexity, and we collaborate with customers to overcome challenges together. It is not uncommon for prospects to contact us because they have not found another injectables CDMO that is willing or able to address their challenges.”
Mark DaFonseca, Chief Commercial Officer at Lifecore
For pharmaceutical and biotech companies navigating the complexities of injectable development and manufacturing, Lifecore offers a combination of technical depth, regulatory experience, and flexible partnership that helps move challenging products from concept through commercialization.
Lifecore Injectables CDMO is the brand name for services provided by the legal entity Lifecore Biomedical, LLC (or its affiliates).
