Neosaxitoxin is a well characterized chemical entity, derived from a primary biotechnology process, developed in a facility dedicated exclusively to research, characterization, collection and purification of neosaxitoxin. This facilities complies with the Standards "cGMP's for Phase 1 Investigational drugs" of the USA-FDA, while maintaining a high level of productive development, and optimizing the production of active pharmaceutical ingredient (API).
Manufacturing is carried out through well-defined, standard and stable processes to obtain the API from the culture of cyanobacteria, thus complying with indications of the ICH Q7 "Good Manufacturing Practice Guidance for Active Pharmaceutical", which states that cGMP should be fulfilled from Proteus Working Cells in controlled environments.
Other standard processes at Proteus are the extraction and purification of Neosaxitoxin, which take place in classified areas. These intermediate stages are controlled by Proteus throughout different parts of the production process to obtain an API aqueous solution in 500mM glacial acetic acid with a final concentration of 0.002% Neosaxitoxin, which undergoes further quality control analysis to meet the specifications defined by the company.
In synthesis, the process consists of two phases:
1.- The mass production in controlled conditions of a cyanophyte clone, which is the synthesizer of the drug substance.
2.- Biotechnology and industrial production of the drug substance obtained from the cellular material (cell lysis) of the clone by solvent extraction, fractioning and biochemical purification, using biochemical preparations, which were designed by PROTEUS SA, thus generating a unique high-volume production capacity. This is a unique and pioneering initiative of its kind worldwide.
The intellectual property of the Collaboration Agreement is protected according to international regulations. This protection was started by, but it is not limited to:
1.- United States Patent Number 6,326,020
2.- Chilean Patent Number 722-2009
3.- Chilean Patent Number 723-2009
4.- International Patent Application Number PCT/IB2010/051187
5.- International Patent Application Number PCT/IB2010/051188
The intellectual property of the Project is granted by:
1.- Pabst Patent Group LLP. Available in: http://www.pabstpatent.com/2.- Clarke, Modet y Compañía Chile Limitada. Available in: http://www.clarkemodet.cl/