Ubichem gains approval to supply cGMP radiolabelled API
The rise of microdosing has increased interest in radiolabelled compounds, prompting companies including PerkinElmer to bolster capabilities. Ubichem gained radiochemical capabilities through an acquisition in 2007 and since then has worked to enhance its offering.
József Répási, managing director of Ubichem, explained to Outsourcing-Pharma that the latest step in these efforts has been the expansion of current good manufacturing practices (cGMP) to the radiolabelling laboratories.
Equipment has been upgraded and installed to give the Ubichem isotope sysnethis group, which has extensive experience working with radiolabelled compounds, a site that is in compliance with cGMP.
Having taken these steps Ubichem had the site inspected by Hungarian authorities for the production of radiolabelled cGMP active pharmaceutical ingredients (API). Répási commented that the site has also been successfully audited by a client.
An agreement between the Hungarian authorities and the EU means the approval allows Ubichem to supply the European market. Répási said that there has been a definite increase in demand for radiolabelled APIs and Ubichem is now well equipped to serve this growth market.
Shipping
The shelf-life of radiolabelled APIs poses difficulties for shipping. To overcome these challenges Ubichem has outsourced shipping to a specialist company with more than 20 years of experience in the radiochemistry sector.
Répási explained that packaging compliant with API and radiolabelling guidelines is used. The radiolabelled APIs are then in shipped in dry ice at -78ºC to maximise shelf life.
Ubichem has sought to ship radiolabelled APIs to the US but the compounds’ shelf-life has limited penetration into the lucrative market, added Répási. Also, there is significant competition from US-based radiolabelled API producers. Japan also represents an opportunity.
