Delivery Platforms for Government Assets.
There is a belief that the technology involved in intensified chemistry is not very mature and therefore carries substantial risk.Some of the small-scale hardware has not been fully industrialised, the developing data collection, process and quality control approaches have not been fully tested with regulatory authorities..
Complicated supply chain.Pharmaceutical manufacturing of a single product through its lifecycle spans multiple functions and sites within each organisation and spans multiple organisations through product acquisitions and contract manufacturing.Thus, the breadth of what needs to be changed to deploy a new platform technology is significant.. Resistance to challenging accepted practice.
Regulatory and patient safety risks are always high up the agenda for the pharmaceutical industry.The unfamiliar and the new are assessed as having higher risk than the known.. How manufacturing sits versus perceived value creation in the pharmaceutical companies.
In reality, pharmaceutical value creation comes from the development or acquisition of promising NCEs, and their ability to commercialise them.
Manufacturing is complicated and costly and may be seen as a necessary inconvenience, rather than a potential strategic advantage..Information gathered through the project lifecycle is often focussed on that needed for construction, not necessarily that needed for operation..
Platforms solution.The digital record of data that sits behind the platform approach continues to add value throughout the operation of the asset and will facilitate increasingly data-driven use cases in the future including feedback loops and digital twins.. Data that feeds through to operation hand over and back into future design.
The bedrock of data that threads all the way through the platforms process, can feed into the circular economy; building a core set of information that can be re-utilised, creating feedback loops that can then inform the design of future assets.In this way, Platform design and how it integrates with the bespoke sections of assets, becomes self-optimising.. Design that future proofs compliance.