Unsure your filling needs will be fulfilled? Have a complex injectable product or process? We say, “Bring it.”
Lifecore is a U.S.-based Contract Development and Manufacturing Organization specializing in the development, fill/finish, and commercialization of sterile injectables.
With a 40+ year regulatory track record and 20+ commercial products, Lifecore offers end-to-end services with experience spanning straightforward to complex formulations. We support organizations of all sizes across pre-clinical, clinical, and commercial stages.
Lifecore is also a leading producer of pharmaceutical-grade, non-animal-sourced sodium hyaluronate which is used as an API and excipient.
Why Choose Lifecore?
We don’t have limitations on what we’re willing to consider. We’re flexible when onboarding customer processes, methods, and equipment at our facilities.
Lifecore has extensive tools and know-how to support demanding requirements, including:
- Sterile API additions
- Range of filtration options including PUPSIT and TFF (sterile & non-sterile)
- Containment and isolators for high-potency compounds
- Flammable and organic liquid handling
- Bubble-free filling
- Low particulate and residue levels
- Controls for shear, light, temperature, oxygen sensitivity, and precise timing of conjugation and other reaction steps
- Vacuum and vent tube stoppering
- Low-viscocity (<100 cps) and high-viscocity solutions (>150,000 cps)
- Long-acting injectables
- Polymers, emulsions, & suspensions
Process Development & Fill/Finish Services
- Development, fill and finish of sterile injectables
- Syringes & vials
- Expertise in highly viscous (exceeding 100,000 cP) and complex formulations
- Proven QMS supports drugs, biologics, medical devices, and combination products
Additional Services
- Extensive on-site microbiological, analytical, and physical testing with redundant labs
- ICH stability studies
- Range of labeling, packaging, and serialization options
Sodium Hyaluronate
- Research-grade, pharmaceutical-grade, hydrogels, and custom modifications
- Broad range of average molecular weights for use in R&D, animal/tox studies, clinical studies, and commercial applications
- US DMF approved, EP-certified, and JP-compliant
For more information – Bring It – CDMO | Sodium Hyaluronate Producer | Sterile Injectable CDMO | Lifecore
Videos
Lifecore Injectables CDMO Capabilities Tour
A HOME for Your Molecule
https://www.lifecore.com/a-home-for-your-molecule/
60 Years of Helping Patients
Technical Feature
High-Throughput Sterile Filtration of Highly Viscous Pharmaceutical Formulations
https://www.lifecore.com/high-throughput-sterile-filtration-of-highly-viscous-pharmaceutical-formulations/
