The plant – in Tredegar, Wales, – is now completed and is currently undergoing tests before it opens its doors in Spring 2013. It will produce solid oral dose film coated and hard gelatin filled capsules.
We caught up with the firm’s director of business development Rob Jones at this month’s CPhI, who told us Penn is currently speaking with some Big Pharma firms about developmental highly-potent (HP) drug products.
“Naturally we’re entering dialogues with some of the bigger players who’ve got active pipelines we can see generating HP molecules. And the level of interest is very high – even six months before we open.”
Jones also told us he expects business will continue to grow as the number of high potency drug products being developed continues to increase.
“Clearly the R&D (research and development) side of the business is having to look deeper and deeper into research libraries,” he said. “Molecules perhaps discarded in the past are now being brought back to the front and a number of those are highly potent. There is an equally big drive into oncology and naturally that’s throwing up molecules that are potent too.”
As for outsourcing HP production, Jones sees a bright future because the molecules are “difficult to handle” and require a specialist. And with only certain providers offering contained facilities – rather than simply kitting out operators in suits – Penn believes its new facility will have the edge.
“We have a long history of handling HP molecules and having dedicated containment resources, but we have now decided to design and construct something from scratch. We were able to agree with the board to have a specific investment in a purpose designed facility that will be using the latest contained engineering,” Jones said.
Earlier this month the facility passed its FDA cGMP (current good manufacturing practice) and pre-approval inspections, meaning it can manufacture products for the US.
In a statement, CEO Richard Yarwood said: “We are extremely pleased with this successful inspection which confirms Penn’s commitment to meeting the highest quality standards. We will continue to invest in improving our quality systems to provide even greater assurances to our customers.”