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Late Phase Development
Clinical batches on aseptic lines designed for changeover between programs.
Small clinical batches on aseptic lines
A 3,000-vial Phase I batch occupies the same changeover, cleaning and validation effort as a run fifty times larger, which is why small clinical batches are difficult to schedule on capacity built for commercial campaigns.
Our filling lines use single-use technologies and robotic operation, which cuts changeover between programs and reduces operational variability at the same time. The practical result is that a small clinical batch can be scheduled like any other.
Formulation optimization
Between the IND-enabling formulation and the one that will be validated, most programs make changes — to concentration, to excipient levels, sometimes to the container. Each change carries a stability obligation and a comparability question, and the aim is to make as few as possible while still arriving at a formulation that can be manufactured reliably.
Optimization runs against the filling format and the sterile filtration behavior, so that the formulation that emerges is one the line can run.
Process development and scale-up
In aseptic scale-up the challenge is consistency: filling accuracy, stopper and seal integrity, hold times and environmental control all have to hold at a larger batch size and over a longer run. Fully enclosed isolation systems and automated filling remove most of the human variability that otherwise appears at that point.
For lyophilized products, cycle development and scale-up run on the same equipment types used for commercial manufacture, which is what allows the cycle to transfer without redevelopment.
Clinical supply manufacturing
Five aseptic filling lines produce clinical trial material for programs from first-in-human through Phase III, in vials, prefilled syringes and cartridges, with drug substance arriving from an API site in the same network, without crossing a border.
Packaging, labeling and distribution are handled by the same organization, including specialty clinical labeling formats and EU batch certification.
Registration and validation batches
Registration batches are made under the process that will be validated. Across drug product campaigns to date, process performance qualification has a hundred per cent success record, including multiple Phase III and commercial programs.
Small batches, scheduled
A 3,000-vial Phase I run occupies the same changeover as one 50 times larger. Single-use systems and automated changeover are what make it a scheduling question at WuXi TIDES.