In October 2013, Aesica announced plans to invest £500,000 ($680,000) into a prefilled syringe facility in Nottingham, UK. However, in an exclusive interview at last week’s CPhI in Paris, the firm said regulatory issues have led to a decline in aseptic capabilities within the UK with Aesica itself exiting the field following an audit last year.
“We had a very small aseptic capability in Nottingham, literally a single room doing some limited aseptic work in order to support clinical trials,” Ian Muir Managing Director Finished Dose told in-Pharmatechnologist.com.
However, an audit by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) at the end of last year pulled the firm up on isolator requirements, Muir revealed, leading to Aesica abandoning its aseptic services and repositioning the suite for potent API manufacture in an isolated type environment.
“At the time we made the decision, we looked at the competitive space and decided we were very small in that space. There were other people clearly in that space and therefore it didn’t appear like a good market opportunity.”
However, since then SCM Pharma – a CDMO with significant sterile injectables capacity – lost its cGMP license, entered administration and had its assets acquired by its main customer, Shire, while the MHRA also issued a statement of non-compliance at Moorfields Pharmaceuticals facility in London.
“Aesica’s situation was a little bit different to SCM where the sterile offering was a core part of their business,” Muir said, adding “the dynamics and the commercial reality [of exiting aseptic manufacture] are quite different.”
However, such pull-outs have left a gap in the UK’s sterile landscape, he continued.
“What we hear now from the market is there has been a situation where there is limited capability about early stage development steriles in the UK. [Aesica is] not in it anymore but the market has gone from a position where there were quite a number of players to very few.”
Core is Key
For firms looking to enter the “lucrative” steriles space, whether in the UK or globally, it is essential to be fully focused as “clearly it is a complex area and if you are going to do it you have to do it perfectly,” Muir said.
“You can’t half do it so if you’re going to be a player in sterile field you have to be in it in a significant way… it has to be a core competency otherwise it doesn’t get the drive and attention it needs.
“If you look at the people known for doing it well, the Vetters of this world, that’s all they do. It’s their core business and they do it well.”
Late last month, it was announced that Aesica was set to be bought by the publically listed firm Consort Medical. As the deal is yet to be finalised and Aesica is in a lock-up period, Muir was unable to comment fully on the deal but did offer some insight into the £230m acquisition.
“There are some areas where we have a common overlap but essentially they are two businesses within the healthcare space,” he told us. “There is very limited crossover at this stage and they [Consort] are clearly much more of a device company.”