Clinical Trial Manufacturing
A facility that was built for drug product development and CTM manufacturing.
Metrics Contract Services offers GMP manufacturing areas for development and clinical trial material manufacturing:
- Twelve manufacturing rooms
- Five suites for potent actives (OEL at or above 1mcg/m3 room air)
- Two suites for potent actives with 100% contained equipment (OEL at or above 30ng/m3 room air)
- Our manufacturing area can accommodate large CTM batches if needed
- All facilities are regularly inspected and meet DEA guidelines for Schedule II-V controlled substances
CTM and commercial batch capacity
- 450kg dry blend (one portion)
- 450kg wet granulation (three portions) by high shear granulation/FBD
Full analytical support for your drug product development and CTM manufacturing project is available, including custom analytical methods development and validation, release testing, stability studies and microbiology testing. Metrics Contract Services offers seamless scale-up services to commercial manufacture from your CTM batch. Technology transfer is a key scientific offering at Metrics Contract Services, and our experienced scientists and manufacturing staff will ensure your project is successfully transferred to your specifications.
Click below image for a detailed layout of the manufacturing facilities in our building.
To learn more about our manufacturing and packaging capabilities in Australia, visit Mayne Pharma.