There are challenges in the development and manufacturing of cytotoxic and highly potent compounds. It is extremely critical to have safety procedures in place and train all employees when dealing with the handling, storage and contaimination of highly potent compounds, especially with Safebridge Categories 3 and 4 compounds. Agno Pharma has in-house expertise and capabilities to provide our client high value-added services in this area. We have cGMP-compliant glove box isolators and dedicated high potency suites with reactors up to 100L.The other scientific challenge in developing highly potent compound is in developing analytical methods to detect the presence of potential genotoxic impurities (PGIs), which generally have specifications in the low ppm range. Agno Pharma has the analytical expertise, experience and instrumentation in overcoming this scientific challenge.
