End-to-End
From manufacture
to trial
The client’s
roadblock
The client was developing a novel inhaled therapy and required a partner capable of delivering both GMP manufacture and full clinical trial support.
The program presented multiple challenges, including the manufacture of a complex inhaled dosage form, coordination of regulated clinical trial supplies, and execution of a first of its kind clinical study in a specialised therapeutic area. Managing multiple vendors risked misalignment between formulation performance, manufacturing execution, and clinical outcomes.
How we
found a way
We delivered an integrated CDMO and CRO solution, managing the program from late stage development
through to clinical execution. Our team undertook GMP manufacture of the inhaled therapy, addressing
formulation stability and ensuring consistent, compliant clinical trial supply.
In parallel, we supported trial design and delivery, contributing to protocol development, regulatory and ethics submissions, site coordination, and trial management.
By combining formulation knowledge, manufacturing control, and clinical oversight within a single organisation, we ensured close alignment between the product’s performance characteristics and the clinical objectives of the study.
This integrated approach reduced handovers, improved decision making, and allowed potential issues to be identified and resolved early, enabling the clinical trial to progress smoothly from manufacture through execution without delay and providing the client with a clear pathway for ongoing clinical development.
Go with ABINITIO
Whether you need us for the whole path, or just one part, we deliver what matters most: progress.
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