Why Leading Drug Developers Choose Microsize
Microsize is THE premier, US-based partner for GMP pharmaceutical micronization services. Our unique combination of attributes has led to our success:
DECADES OF EXPERIENCE
With nearly three decades of experience, Microsize has tackled an unparalleled number of challenges including hundreds of small molecule APIs, and a range of highly functional pharma excipients. We’ve processed millions of kilograms of APIs over more than 10,000 production campaigns. No one has solved more challenges than Microsize.
UNPARALLELED DEPTH OF EXPERTISE
At Microsize, we’re not just users of micronization and milling equipment; we actually design the technology we use, and it’s been implemented for decades from early development through NDA-approved commercial products. Many of the world’s leading pharmaceutical products sold today have had particle reduction performed by Microsize using our own proven micronization technology. We know micronization! Complementing our manufacturing is an experienced R&D team and a range of analytical equipment and services to ensure client success.
LARGEST US-BASED FOOTPRINT
Microsize has a footprint of over 100,000 sq ft comprising three adjacent facilities near Philadelphia, PA. Additional expansion space is available for products in the pipeline, future growth and/or client dedicated “remote factory” suites. Routinely FDA inspected for over three decades, the sites provide the appropriate controls expected by the pharma industry to ensure a fully integrated, uninterrupted processing from preclinical through commercial launch.
WORLD-CLASS CONTAINMENT TECHNOLOGIES
Microsize has been an early adopter of containment technologies for high potency active pharmaceutical ingredients (HPAPIs). By offering containment isolators in various sizes and configurations including rigid and flexible softwall, single-use configurations, Microsize is able to adapt to desired OEB band (1-5) and batch size to provide the safety and throughput necessary for client success.
HIGH TOUCH, LOW BUREAUCRACY
A signature of Microsize is our focus on enhancing the client experience. We know speed and timely communication are of utmost importance. At Microsize, we bring the best of both worlds – Providing the high customer-touch, flexibility and nimbleness of a smaller organization, COMBINED WITH the world-class facilities, quality systems, and capabilities you’d come to expect from a larger global CDMO.
FAQs
Q: What makes Microsize unique among pharmaceutical CDMOs?
A: Microsize combines over 30 years of experience, specialized micronization and classification technologies, and one of the largest US-based micronization footprints to handle even the most challenging poorly soluble and highly potent compounds.
Q: How large are Microsize’s facilities?
A: Microsize operates three FDA-inspected facilities totaling over 100,000 square feet, supporting scalable, high-quality micronization from small development batches to large commercial campaigns.
Q: What containment technologies does Microsize offer?
A: Our facilities are equipped with containment isolators in various sizes and configurations for safe handling of high-potency APIs (HPAPIs), including both hard-wall and single-use systems.
Q: How does Microsize ensure efficiency and client focus?
A: We prioritize high-touch, low-bureaucracy service, streamlining processes while maintaining strong client relationships.