High Potency Products
AMRI has special capabilities in high value-added areas of pharmaceutical development and manufacturing, including High Potency Manufacturing.
Cytotoxic and other highly potent compounds present a number of potential challenges in their production and handling. AMRI has extensive experience in the cGMP production of these types of compounds, from grams to hundreds of kilograms per year.
State-of-the-art high potency manufacturing suites include:
- cGMP-compliant glove box isolators
- Reactors capable of handling materials with OELs under 1 ug/m3
- Manufacturing capabilities up to 1200 liter reaction scale with batch sizes of 50-100 kilograms