Completed Materials & Manufacturing Chemistry

Improved downstream operation through formulation innovation

In plain English

AI plain-English summary

Making a biologic drug—like an antibody or enzyme—is a delicate, multi-step process, and the liquid buffers used to keep the protein stable during purification often fail, causing the drug to degrade and reducing the final yield. This project tackles a hidden bottleneck in manufacturing: the standard chemical solutions used in downstream processing (DSP) are not optimised for protein stability. Currently, drug makers accept significant product loss during these steps because no better buffer exists. The team—combining formulation chemists from Arecor with process engineers from Fujifilm Diosynth Biotechnologies and CPI—will design a new platform of formulations that keep proteins intact through the most damaging stages of purification. If successful, these improved formulations could cut production costs for all biologic medicines, lowering prices for healthcare providers. They may also make it possible to manufacture biotherapeutics that are currently too unstable to produce at scale. This is not fundamental science; it is applied process innovation aimed at a concrete industrial problem. The result would be a quieter, less visible improvement to the pharmaceutical supply chain—one that patients never see but that could make expensive treatments more affordable and more widely available.

View original technical description
The aim of this project is to provide new formulations that bring about a step change in biopharmaceutical yield and quality by improving product stability through the most protein degradation sensitive/impactful areas of downstream processing (DSP). This is a novel approach to improving process efficiency as currently protein products have comparatively limited stability in the existing default DSP buffers. To develop a new platform of formulations and formulation strategies this collaborative project will bring together the formulation expertise of Arecor with the DSP expertise at Fujifilm Diosynth Biotechnologies (FDB) and The Centre for Process Innovation (CPI). The platform of formulations and the formulations strategies developed can then be applied to reduce production cost of all biologics to pharma and ultimately cost to healthcare providers. These new formulations may also enable the production of biotherapeutics that are currently very difficult/impossible to manufacture.

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Related Research

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Bioprocessing of High Concentration Protein Solutions: Quality by Digital Design Approach
Development of predictive tools and formulations for improved stability and delivery

Original classification

Collaborative R&D

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