Quality-by-Design: from molecule to intestine
Systems-based Pharmaceutics (SbP) is a holistic approach to the development and optimization of drug manufacture and drug delivery.
It has the potential to transform pharmaceutical process development and design, leading to significantly accelerated development, improved R&D efficiency, reduced cost and risk and many other benefits.
A key target is the reduction of the number of iterations that are currently required between product design and manufacturing process design, subsequent manufacturing steps, bioavailability targets and drug product and process development.
The SbP approach allows organizations to capture and deploy knowledge in a more efficient and consistent manner than at present, and thus address the limitations resulting from the 'silo thinking' that is prevalent in many companies.
It also helps identify the weakest link in the product-design-to-drug-delivery chain and hence the optimal targets for further R&D investment.
SbP implements a systems-based modeling approach that is well-proven in many sectors including chemicals, consumer goods, and clean energy.
This applies high-fidelity mathematic models of a manufacturing process, validated against experimental data, to explore the design and operational decision space rapidly and effectively. The approach enables companies to make globally optimal design and operating decisions based on delivering the required key performance indicators (KPIs).
In the pharmaceutical context, a systems-based approach considers the entire manufacture-to-delivery system drug substance manufacturing, drug product manufacturing, absorption, pharmacokinetics, pharmacodynamics as a single related system. By considering all key effects simultaneously, it is possible to relate manufacturing decisions directly to drug delivery (KPIs).
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