Offering 100,000 sq ft of commercial oral solid dose manufacturing.
Our facilities have partnered with the FDA to showcase and provide training for FDA Consumer Safety Officers and FDA Medical Product Analysts pharmaceutical new and novel technology. This has been conducted both virtually and on-site.
Download the Irvine Site Flyer here to learn more about the available equipment and capabilities at this site.
Commercial Manufacturing of Pharmaceutical Drug Product
We manage the entire product lifecycle: Preclinical,
clinical and commercial development and manufacturing with analytical services and end-to-end supply chain.
We handle high barrier to entry and reproducibility: Our two locations in Irvine, CA are offer commercial scale manufacturing of tablets, capsules including parallel formulation, process, and analytical and development support services in-house.
We scale-up clinical to commercial supply: With decades of expertise in ASD, SDD and HME, our U.S. facilities deliver pharmaceutical drug product from scale-up to commercial supply.
Commercial Oral Solid Dose Development and Manufacturing Services include:
Amorphous solid dispersion (ASD) of oral solid dosage forms (OSD)
Hot Melt Extrusion (HME)
Spray Dried Dispersion (SDD)
Multi-Layer Tablets
Dual-Bead Encapsulation
Multi-Pellet/Dose Capsule Filling
Multi-Particulate Systems
Modified, Controlled and Sustained Release
API - Polymer Bead Layering
Dry Granulation
Spray Granulation
Precision Coating
Solvent Coating
Functional Coating
Roller Compaction
Commercial Manufacturing in Irvine, California
Potency Capability: OHC 3 out of 4 (OEL: 0.03 ug/m³ – 10 ug/m³)
Number of Commercial Products: 5+
Number of Employees: 110+
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