The new intermediate scale processing suite (ISPS), which has been constructed at its facility in Cincinnati in the US, will focus on helping drugmakers to scale-up processes according to US Food and Drug Administration (FDA) quality by design (QbD) principles.
The additional capacity will doubtless be a further boost for Patheon’s reputation for the successful development of commercial scale manufacturing processes. Earlier this month the Canadian firm and partner Procter & Gamble received the “most effective scale-up and technology transfer” prize at this year’s European Outsourcing Awards.
The centre piece of the new ISPS facility is an intermediate scale Diosna-P300 high shear granulation unit that is coupled with a Niro-MP4 fluid bed dryer that has solvent and high potency compound handling capabilities.
The unit can process active pharmaceutical ingredient (API) batches in the 35 to 115kg range that are sufficient for regulatory registration, validation and commercialisation.
Such quantities are also ideal for final product process development and will allow firms to strike a balance between creating sufficient quantities for multiple design iterations and the cost of producing the API in question.
Terry Novak, president of Patheon’s North American operations, commented that: “The ISPS provides us with another valuable service to address the unique needs of our customers.”
Novak added that because the capabilities offered by the dedicated unit enable experimental assessment of APIs at sub-commercial quantities it will cut overall development time and significantly reduce the cost of process scale-up.
QbD – scientific quality at every stage
The FDA’s QbD guidelines are intended to provide a scientifically robust, statistically sound approach to drug development from initial concept to commercial launch.
A key aspect of the agency’s plan is that drugmakers and contract manufacturers build up a detailed understanding of how a product’s attributes relate to its commercial performance. Such expertise will then serve as the basis for a more generalised development approach across the industry.
As a leading contract manufacturer Patheon’s adoption of the approach QbD, which was first announced by the FDA in 2002 and is still under industry consultation, suggests that the guidelines are compatible with current trends and developments in the contract manufacturing sector.