Indena opens kilo lab for highly potent APIs 15th February 2018
Indena, a Milan, Italy-headquartered contract manufacturing organization for the identification, development, and production of active pharmaceutical ingredients (API) derived from plants, has opened a new kilo lab for highly potent APIs (HPAPIs), including natural, semisynthetic, and totally synthetic compounds.
The new kilo lab is designed to handle the production of toxic substances with an occupational exposure limit of 20 ng/cubic meter. Indena says this level of confinement also allows for handling toxins, such as maytansine derivatives, which can be used for antibody-drug-conjugate manufacturing.
Indena says the new plant is able to produce clinical or industrial batches and performs full synthesis, and the company can now handle products and processes from small-scale good laboratory practice batches for toxicology, cGMP batches for clinical trials, to large-scale commercial manufacturing.
The validation of the first total synthetic HPAPI is currently ongoing in the new kilo lab, says Indena.