Core services include fill-finish capabilities to produce clinical investigational lots, engineering lots, process validation lots, and commercial-scale lots. Fill-finish activities include analytical testing development, scale-up, formulation, filling, finishing, process optimization, process validation, labeling, packaging, and distribution. Nanotherapeutics has established small-scale fill-finish infrastructure to support pre-clinical batches, but the process of transforming bulk drug substance to Final finished product/dosage form such as vials and pre-filled syringes, for large-scale clinical and commercial supply is outsourced to cGMP compliant CMOs.
Therapeutics against chemical, biological, radiological and nuclear (CBRN) warfare agents are required to support the Armed Forces across a range of military operations. As such, Nanotherapeutics is developing and fielding systems with the Department of Defense (DoD) that provide treatment for exposure to chemical, biological, radiological and nuclear (CBRN) agents. In particular, a core competency related to fill/finish is the development of auto-injector devices for delivery of specific nerve agent antidotes following nerve agent exposure. The fill/finish capabilities are used to support the filling of the auto-injector drug container (glass syringe/cartridge) with the specific nerve agent drug. Nanotherapeutics currently has on-going government contracts related to this effort.