Clinical Trial Production and Supply
Using our in-house manufacturing facilities and equipment, we have the ability to manufacture your drug product and medical devices for use in development studies and clinical trials.
In addition to our extensive development manufacturing facilities, we have separate GMP manufacturing facilities for dry powder inhalers (DPIs), pMDIs and nebulizer medical devices, and we have further capability to handle biological molecules.
A dedicated manufacturing team operates our GMP manufacturing facilities and equipment, which are relevant-to-commercial scale and meet all required EHS, quality and regulatory standards.
We have the ability to manufacture and deliver your commercial products and devices. This includes manufacturing DPI, pMDI and nebulizer components and finished devices for both clinical trials and commercial scale.
With GMP spray drying, powder blending and filling, as well as DPI device assembly, choose Phillips Medisize as your partner for dry powder development programs—from early development through all clinical phases of development to small-scale commercialization.
Spray Drying
With development and GMP spray drying capabilities providing batches from 1 g to 10 kg, you can be confident in scale-up with comprehensive process understanding and controls.
Powder Blending
Our powder blending capabilities offer flexibility based on the needs of your formulation up to 30 kg batch size:
- High shear
- Low shear (tumble blending)
- Mechanofusion
Capsule and Blister Filling
Volumetric, dosator and fill-to-weight technology
Device Assembly
Semi-automated device assembly up to 1 million devices per year
Case Study
Substitutable DPI Manufacturing
Opportunity
For a substitutable DPI drug product for the US market, we manufactured the drug product for a partner through the entire drug product development cycle: from laboratory-scale batches for development to pilot-scale clinical batches to commercially representative bio-equivalence batches.
Solution
The bio-equivalence batches were manufactured at a 30 kg blend scale, with each blend being filled into over 30,000 blister strips and assembled into inhalers using components molded from multi-cavity tools that had been installed at a contract manufacturing organization. The FDA reviewed the manufacture of these batches and was satisfied that the manufacturing equipment, processes and controls were fully representative of those used subsequently at the partner’s commercial manufacturing site.
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