Who We Are
We’re a Minnesota, USA–based injectables CDMO with acknowledged technical grit—scientific and engineering pathfinders who thoughtfully meet challenges head‑on and develop robust, efficient processes that scale.
Backed by 40+ years of global regulatory success, we deliver consistent quality, reliability, and patient safety you can count on.
60
years supporting
patients
patients
40+
year global
regulatory track
record
regulatory track
record
20+
commercial
products
products
What Can We Do?
Proven QMS can support drugs, biologics, medical devices, and combination products:
- Biologics (mAbs, peptides, proteins)
- Small molecules
- Hydrogels, with option to incorporate Lifecore-manufactured hyaluronic acid as an API or excipient
- Microparticles/nanoparticles (lipid/mRNA)
- Biopolymers & synthetic polymers
- Long-acting injectables
- Emulsions/suspensions
Extensive Tools & Know-How
- Filtration: PUPSIT, TFF (sterile & non-sterile applications), sterile filtration (150,000 cps requiring up to 850 psi)
- Sterile powder API additions
- Containment and isolators for high-potency compounds
- Flammable & organic liquid handling
- Low-viscosity (<100 cps) & high-viscosity solutions (>150,000 cps)
- Homogenization including high-shear mixing (>20,000 rpm)
- Bubble-free filling
- Low particulate & residue levels
- Controls for shear, light, temperature, oxygen sensitivity
- Precise timing control of conjugation and other reaction steps
- Vacuum & vent stoppering
- Single-use, glass, & 316L stainless steel components
Capabilities & Experience
Single Site for Clinical to Commercial Services
- Formulation and process development
- Fill finish for vials, syringes, and cartridges
- Extensive on-site testing, method development, and stability
- Packaging
downloadable Content
Lifecore Capabilities Overview Flyer
Lifecore
Complex injectable product or process?
