Catalent Micron Technologies – The First Name in Micronization™
Catalent Micron Technologies is a leading international provider of particle size reduction and analytical services. We deliver first-class pharmaceutical contract micronization , milling and analytical services combining quality, speed-of-response and industry-leading expertise.
Catalent Micron Technologies has more than 25 years experience handling pharmaceutical materials and is a leader in air jet milling micronization. We are capable of processing both R&D and commercial volumes alike and are equipped with state-of-the-art systems to ensure total product containment and quality. We can provide tailored solutions for your molecule incorporating salt form optimization, pre-formulation services as well as formulation of your micronized materials into optimal inhaled or oral dose form through clinical and commercial supply.
Particle Size Reduction Technology Advantage
Proven, dependable, and extremely versatile, micronization is the most efficient, cost effective way to achieve top quality particle size reduction results. Offering a range of technologies for routine, challenging and highly potent compounds, our team offers pharmaceutical micronization methods and services that enhance and advance your compound, with:
- Proven – leading know-how and established processes – used for decades and well understood by regulators
- Versatile – effective particle size reduction services across a wide range of oral and inhaled products
- Scalable – enabling optimization and control of particle size and distribution, from R&D to commercial scale
- Dependable – producing high yields that consistently exceed alternate particle size technologies
- Precise – using critical process parameters to support regulatory submission expectations
Complex Micronization, Milling and Particle Size Analysis
Catalent Micron Technologies is the preferred solution provider for the most complex, specialized requirements in pharmaceutical micronization, we have the expertise to handle your toughest particle size specifications.
Full range of capabilities in particle size reduction including:
- Mechanical milling
- Cryogenic milling
- Highly potent and cytotoxic compounds
- Comprehensive analytical services
Bioavailability Solutions Toolkit
Catalent can now support your R&D teams earlier in the development cycle with a set of bioavailability solutions unrivaled in the industry.
From API optimization, particle size optimization and formulation services, to drug delivery technology selection and final dose form design services; Catalent can help you at the earliest stages of the drug development process. Our team can provide end-to-end solutions to accelerate your programs to clinic and to market, utilizing our broadest expertise, best technologies and rigorous science, including:
- Optiform® API screening and optimization platform
- FormProRx™ selection tool for optimal finished dose
- Preformulation/Formulation expertise including:
- Clinical packaging and integrated clinical supply solutions
- Global clinical and commercial manufacturing capabilities
- Highly potent and cytotoxic drug handling
Micronization Quality by Design (QbD)
Catalent Micron Technologies understands the challenges in technology transfer and lean manufacturing and will provide expertise in milling/micronization to assist our clients with their Quality by Design (QbD) initiatives. We develop screening and optimization Design of Experiment (DOE) protocols and conduct well-defined milling/micronization runs. We also provide insightful risk assessment to custom develop the optimal design space for our client's product. Our QbD offerings are part of a dedicated approach to customer support, to fuel continuous process improvements, cost savings, and regulatory flexibility.
Catalent Micron Technologies operates two state-of-the-art cGMP facilities, and employs approximately 100 people across its 84,000 sq. ft. facility in Malvern, PA and its 19,000 sq. ft. facility in Dartford, U.K. Both facilities have successfully passed all required regulatory inspections and their quality systems have been successfully audited by more than 200 pharmaceutical companies worldwide.