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.
The Department of Health & Human Services (HHS) has awarded Nanotherapeutics a contract requirement to establish a Fill and Finish Manufacturing Network (FFMN) to provide filling and finishing capabilities as core services for influenza vaccine products and other public health emergency pharmaceutical products. This will help to address national security concerns and to augment public health needs on a cost-effective, reliable, and sustainable basis. The FFMN will connect HHS industrial partners with needed technical and regulatory expertise including facilitating interactions with FDA's new regulatory science initiative. Establishing the FFMN with multiple capabilities and differing manufacturing platforms will allow for maximum flexibility and adaptability to respond to changes in technology and/or disease threats.
Core services may be provided to support the filling and finishing of products including sterile injectable drug, biopharmaceuticals, monoclonal antibodies, recombinant proteins, antitoxins, bacterial or viral vector-based products, and attenuated/killed virus vaccines used to prevent and/or treat, but not limited to, pandemic influenza. These or other candidate products could be filled and finished using technology platforms including, but not limited to, powders, liquid or lyophilized vials, single dose or multi-dose, prefilled syringes or sprayers, single packed dose or multi-packed doses.
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.