Late-Stage Clinical Supply
"The combination of the J.POD® facility design and our standardized platform are enabling us to seamlessly transfer work around the globe as needed by our customers. For example, we can be manufacturing late-phase clinical material at our J.POD in the US, and we can then quickly transfer that process for commercialization to the J.POD facility in France.
Our unique continuous manufacturing platform technology can also de-risk supply by producing huge quantities of antibody mass in fewer batches and at smaller scale than traditional batch manufacturing. This allows our partners to save time, energy, and resources all along the path to commercialization, rather than being forced to increase bioreactor size (scale-up) or bioreactor quantity (scale-out) as their CMC progresses.”
Kevin Ingham, Manufacturing Operations and Site Head, Redmond, US
Late-Stage Clinical & Ph III Supply
We possess the capability to provide support for late-stage clinical programs, regardless of whether an intensified process has been developed beforehand. By leveraging existing cell lines and transitioning from fed-batch to perfusion and fully continuous modes, we mitigate the scaling-up risks while reaping the benefits of lower commercial COGS and a more adaptable supply chain.
- Fed-batch process assessment and conversion to continuous mode
- Process characterization, validation & PPQ campaigns
- Ph III DS manufacturing
- 500/1000L scale enabling up to 50 kg batch
- One J.POD facility offers a mass output of up to 2,000 kg/year
- Stability studies
- Regulatory support/ Market launch assistance
Continuous manufacturing emerges as the ideal solution for molecules, especially those with uncertain future indications or potentially facing increasing mass demand over time, offering unparalleled flexibility to meet evolving needs.
No Scale-up From Late-State Clinical to Commercial Supply
Our continuous bioprocessing platform inherently avoids the typical challenges encountered with traditional process scale-up strategies. This encompasses the scale-up of bioreactors and potential technology transfer to larger-scale manufacturing facilities.
Flexible Ph III Supply Chain
We can adapt the duration of our manufacturing process to match supply demand and meet from low needs (ADCs, orphan indications) to high mass outputs (>>500kg) in our own J.POD network.
Additional trains can be added into an existing facility
- Maximum flexibility for build out of facilities
- Limited CAPEX at the beginning
- Fully adjustable to clinical and market needs
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