According to the contract manufacturing organization (CMO), the new facility enables the production of small batches from 100g to approximately 1,000g. The facility is able to provide compounds with various potencies and containment degrees.
"The setup in the new facility of CordenPharma Plankstadt is very flexible – it allows for operations to take place at three different levels of containment," said Jason Bertola, director, global highly potent and oncology platform, CordenPharma International.
"Basically, it progresses from an open system for non-highly potent compounds, to a semi-closed system (sliding glass pane) to a fully enclosed system for OEL below 1mg/m3. The containment systems can be connected by Rapid Transfer Port (RTP) to allow the transfer in and out of the individual barriers safely," he told us.
As Bertola explained, the production of small technical batches was a gap in CordenPharma's service offering and the new facility addresses this gap. "This area is non-GMP and designed for development work," he added.
The addition follows a series of investments made during the past year, including expanded capacity and capabilities at its Boulder, Colorado facility in the US.
The company has also recently implemented a program to address corporate and quality systems, organization structure and infrastructure, and includes a process to involve customers in improving transparency.