Microsize Contract Manufacturing & Development (CDMO) Profile
Microsize was created from a growing demand for solubility and bioavailability enhancements utilizing Solubility Characterization technologies that accelerate Speed-to-Market & Optimization.
Microsize was spun out of the Lonza network in 2022 and is now the largest, independent CDMO in the U.S. specializing in solubility enhancement and particle size reduction for the Pharma industry, from small-scale, pre-clinical development to full-scale cGMP commercial manufacturing. We are focused on the DS » DP interface.
With over 30 years of experience, Microsize has developed deep subject matter expertise around micronization and the associated analytical, quality, and containment systems critical to delivering the results required by the pharmaceutical industry across the spectrum of APIs & excipients, including HPAPIs, regulated and controlled substances and other difficult to handle materials.
Microsize has the experience, expertise, and domain knowledge to understand your specific process (CPPs) and optimize it to meet your critical quality (CQAs) and material (CMAs) attributes. We provide continuity of scale-up from lab to pilot to commercial with internal tech transfer through commercialization. And we can customize the micronization and milling technology as needed to augment our inventory of jet mills (1†– 30â€), turbo screen air classifiers, vibratory/micro feeders, and continuous blending technology. This ensures that scale, phase, and material-appropriate solutions are utilized for your projects and campaigns, thereby optimizing the quality, throughput, and associated costs.
CDMO Services:
Small Molecule Drug Substance Manufacturing (API); Drug Product Formulation (FDF); Research & Development; Analytical Development Solids
Year Founded: 1994
Head Office: Quakertown, US
Number of Facilities: 1
Facility locations: North America
Website: Visit the Microsize website
Linkedin: Connect on Linkedin
Current Capacity: We have ample capacity for process development as well as multi-metric ton cGMP commercial processing and building out additional capacity based on forecasted requirements…