AFMPS OK for NextPharma's sterile product development centre
The facility, in Braine l’Alleud outside Brussels, was officially approved by the AFMPS earlier today after what managing director Sean Marett said had been a successful inspection programme.
“We are delighted to report that following on from this successful inspection we will immediately commence GMP manufacture for existing customers and finalise preparations for those new customers with whom we are in late-stage discussions.”
While Marett did not provide specifics on the new customers, he did add that the contract talks are focused around the manufacture of a developmental drug in a project starting sometime this year.
This type of work is likely to be the main focus of operations at the plant, which has the capacity to support services for a full range of development projects from pre-formulation through to Phase III clinical trials.
It also houses analytical laboratories for analytical development and testing as well as full lyophilisation capabilities for trial materials that can be scaled-up to full commercial production.
One stop solution
The broad range of capabilities at the new plant are in keeping with growing industry demand for full service outsourcers and fit with the expansion strategy NextPharma recently employed at its facility in San Diego, US.
In October, the firm added clinical trial support services to the manufacturing and lyophilisation capabilities already based at the US site.
At the time, Marett told Outsourcing-pharma that “There has been a clear trend over the last few years for companies to look for the ‘one-stop solution ’approach to outsourcing services.
“With a single interface we offer our clients an integrated full service approach to development of drug dosage forms,” Marett continued, stressing the benefits that the approach can provide customers in terms of costs and timings.
