Process Development & Technical Transfer

Developing robust and reproducible manufacturing processes with comprehensive process understanding and controls is critical to the success of your development programme.

We can scale-up from laboratory through to commercial scale, enabling a seamless transfer to commercial manufacturing sites.

We also have strong installation engineering capability to install and qualify manufacturing equipment and offer post-installation technical support.

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Case Study

pMDI process development

The manufacturing process development for flutiform® pMDI product started on a very small scale of 6L and was progressed through scale-up to a pre-commercial batch size in our 270L pilot scale GMP pMDI filling plant. This allowed for the smooth transfer to our selected contract manufacturing organisation (CMO), where the commercial process was successfully implemented and validated. Our CMO has supplied worldwide markets since 2012 without any interruption and is currently evaluating and is currently evaluating further upscaling to improve the efficiency of flutiform® manufacture.

Other available services

Product Manufacturing

See how our in-house manufacturing facilities and equipment can support your programme

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Explore our dry powder and liquid formulation capability

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Regulatory Services

All formulation, device, and development services are supported by our regulatory group

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Device Platforms

See how our DPI, pMDI and nebuliser technologies can support your novel or generic programme

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