Highly potent API (HPAPI) drug development is a growing segment in the pharmaceutical industry. The number of small molecule drug candidates that are highly potent continue to grow. Many of these are very specialized and require very small amounts of material which can cause a problem when looking for a development and/or manufacturing partner. Some CDMOs will not consider certain high potency projects based on the volume and the potential revenue. Flamma can be a viable option to consider.
While HPAPI manufacturing presents significant challenges for innovator companies, Flamma looks to work as a trusted partner to overcome the hurdles of development & manufacturing. Our Flamma USA site has a dedicated high potency suite. This cGMP kilo lab has an isolator with 3 separate lines an OEL of greater than 0.1μg/m3 along with a walk-in hood. Flamma USA also has a license for controlled drug substances (Schedule II to IV).
At Flamma Italy, we have the ability to handle materials with an OEL >1 μg/m3. Using our inverted basket centrifuge (with an ISO 8 discharging room) as well as various filter dryers, Flamma can be a nice alternative for customers looking for a trusted partner with the flexibility to move projects along.