Contract manufacturing organisation (CMO) Recipharm commenced negotiations to make LIDDS’ Liproca Depot in April 2015, and began developing a process for the commercial production the modified-release cancer candidate later that year.
And yesterday Recipharm announced a dedicated manufacturing line adapted for GMP production has been established at its facility in Solna, Sweden.
“This was a very challenging project as it required the purchase, installation and qualification of several pieces of equipment,” Torkel Gren, general manager of the facility told in-Pharmatechnologist.com.
“Some of this equipment has not been used in the pharma industry before. Recipharm has experience in setting up new types of technology for GMP manufacture so this was a project that we were well suited for.”
In total seven pieces of new equipment have been installed to make Liproca Depot, Gren revealed though he could not comment on either the cost of the project or which company footed the bill.
Liproca Depot comprises of a modified-release formulation of 2-hydroxyflutamid, prepared as a paste, delivered in a pre-filled container/syringe, which also acts as mixing equipment of the paste prior to injection.
Using LIDDS’ NanoZolid technology, the local administration could offer advantages over current prostate cancer treatments including fewer side effects, reduced dosing frequency and improved patient compliance.
The manufacturing process consists of three main stages: nanocrystal activation with heat, micronisation and drug dispersion, and drug encapsulation by hydration and isotatic pressure.
According to Gren, line could be used for future LIDDS’ pharmaceutical formulations based on the NanoZolid technology.