In the future, thanks to the continuous manufacturing approach, every project will have its own customized technology and/or manufacturing solution, however in the meantime, current and medium-term pharmaceutical projects need to take advantage of existing multipurpose manufacturing solutions.
The golden rule to easily advance a project, from research through clinical supply and finally to launch and commercial manufacturing, is to be able to place it in the most appropriate manufacturing solution. This means using the most suitable technology (using the right equipment) and the most suitable manufacturing solution (working with the right CDMO).
When clients approach us, this is the classical question: “I need spray-drying capabilities for my project: whom could you recommend?” Instead of answering, we start asking several questions just to have a clear picture of our client’s needs.
“Is your powder for medical food or for pharma? What is the potency of your product? How is it classified? Is your powder for an inhalation application or for an oral solid product? Is it a Drug Substance or a Pharmaceutical Intermediate? Are you at development scale, clinical supply or registration? What is your theoretical commercial forecasted volume? Do you need upstream or downstream activities? What kind of analytical characterization do you need? etc.”
25+ years of experience in the particle-engineering field allow Oriento to provide the most suitable matching between project requirements and appropriate manufacturing site. An internal extensive know-how accumulated over decades allows us to provide directions leading to the most suitable solutions as well as back-up sites within the proprietary database (which includes more than 40 partners), assessing strength and weakness of each solution.
For most of the different solutions needed, Oriento can grant a privileged access thanks to a multiyear collaboration with most of these sites. In case the client desires it, project management and/or Person-In-Plant (PIP) for the spray-drying step can also be offered.