Micron Technologies’ laboratories provide cGMP analytical testing to the pharmaceutical and biotechnology industries on a contract basis. Our dedicated staff can help expand, as well as support, the in-house capabilities of our customers.
Using validated, state of the art equipment, our laboratory offers the following services:
Material characterization: The physical characteristics of a drug substance can have a significant influence on the efficacy of a final drug product. Understanding a compound’s particle size, particle shape, crystalline phase, amorphous content, density, and other characteristics is a key step in the chemical development process. Micron Technologies’ laboratories provide a wide assortment of material characterization techniques and can support milling operations with effective, real-time data on your active ingredient.
Stability testing: Understanding the effects of temperature and humidity on drug purity and performance is crucial to developing a consistent product. At Micron Technologies, we offer ICH compliant testing and sample storage to support our customers’ drug substance and drug product stability needs.
Product release testing: When a product is ready to go to market, we’ll provide the necessary release testing to ensure it is cGMP compliant.
Method development and
validation: As a global leader in drug substance micronization, we analyze thousands of samples per month. With an emphasis on material characterization techniques such as particle size analysis, surface area analysis and x-ray powder diffraction, we offer a wealth of experience in method development and validation for these techniques.
Personalized project management is provided for each analytical testing project resulting in:
- Rapid turnaround
- Additional expertise for customer teams
- Trusted results
