On October 23, Almac announced a successful inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) at its facility in Loughborough, UK.
At the CPhI Pre-Connect Congress in Frankfurt – held the same day – Almac’s EU head of business development Brian Eastwood said the contract development and manufacturing organisation (CDMO) is looking to enter the steriles space at a niche, small-scale, and told delegates the new Loughborough-based facility has the capabilities required.
“We will eventually move into the steriles market, and this particular facility also has a steriles manufacturing suite onsite,” he told delegates at the CPhI Pre-Connect Congress in Frankfurt.
The ex-AstraZeneca site is “a big facility,” with a lot available for good manufacturing practice (GMP) production, he added.
Spokesperson Kerry Lyle has since told us Almac’s move into the sterile injectables market is a “long term strategic growth area for Almac and one which we are reviewing in terms of market size and client requirements.”
“Unfortunately we are unable to provide any specific details regarding this area at present."
She added the successful MHRA inspection at the Charnwood, Loughborough site will enable Almac to develop, manufacture and pack non-potent, solid oral drug products for clinical trials and commercial supply.
A growing market?
“Solid oral dose forms still represent a big portion of outsourcing, although the outsourcing of steriles is on the increase," Eastwood told delegates.
Steriles facilities are under stress from regulatory authorities, he continued, adding that good quality, contract manufacturing organisations (CMOs) in the space are limited.
“What we’re gathering [from our clients] is that there are not that many good quality CMOs in that field that can perform development and GMP manufacturing,” said Eastwood. “There is good potential for growth."