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ATMI Life Science
Dutch biopharmaceuticals producer OctoPlus has begun manufacturing operations at its new facility in Leiden, the Netherlands.
The unit, which is adjacent to OctoPlus’ existing manufacturing operations, more than doubles its production capacity and, according to the firm, will help it keep pace with growing customer demand.
Company spokesperson Rianne Roukema explained that the plant will produce everything from antibodies and peptides to traditional small molecules, with the focus being on injectable drugs and complex formulations.
Roukema told Outsourcing-pharma that the Leiden site will make drugs, including liposomal and controlled release microsphere formulations, for assessment in clinical trials but added that it does have limited capacity for commercial manufacture.
She suggested that the facility is “rather unique” explaining that “not many manufacturing facilities are capable of producing complex formulations on a small scale.”
Roukema confirmed the plant complies with Dutch and European authorities’ good manufacturing practice (GMP) guidelines and that it will also operate according to US Food and Drug Administration (FDA) standards.
Hi-tech focus to stave off Asian pressure
Octoplus’ focus on complex formulations is a growing trend among contract manufacturing organisations (CMOs) and development services companies on both sides of the Atlantic.
The rationale seems to be that in order to compete with regions like Asia where contract manufacture can be carried out more cheaply European and North American CMOs need to offer more specialised services to attract business.
Unlike many CMOs that have expanded into high-potency API production, the most recent example being US group Azopharma, OctoPlus is combining its formulation expertise with small-scale manufacturing capacity.
