Biopharmaceuticals are large, complex medicinal drugs manufactured using biological sources, which can provide targeted treatment with fewer side effects compared to traditional pharmaceuticals, to give health benefit to patients suffering from conditions ranging from diabetes, cancer, cardiovascular disease, infections, and immune diseases. The scope of biopharmaceutical products includes therapeutic proteins, monoclonal antibodies (mAbs), vaccines, and cell & gene therapies.
The worldwide demand for biologic drugs is growing significantly driven by the increasing number and sales of recombinant mAbs, which is expected to reach globally the market of $179.56 billion in 2025, at a CAGR of 11.9%. To satisfy the requests for mAbs-based therapies, industrial production of mAbs have been optimized for higher titres by significant improvements in cell culture media and recombinant technologies in the upstream processing (USP). However, this development created a bottleneck in the following downstream (DSP) stage, which currently relies on complex and expensive separations, primarily based on protein A chromatography, usually operated in batch mode. There is an ongoing need to reduce the costs and the risks associated with mAbs development and manufacture in order to address new treatments and extend the availability of these medicines, against a background of tightening and restricted health care budgets. Therefore, the challenge now moves to rise access to such medicines through being able to isolate and purify them at target scale with reduced costs and environmental impact.
On these premises, the main objective of the AMECRYS project is the development of an innovative, continuous, downstream processing for mAbs purification, based on template-assisted membrane crystallization (TMC) as key-unit, leading to the complete replacement of the conventional multi-step batch protein A chromatography-based platform. The expected impact is the decrease of both Capex and O&M costs in mAbs purification, footprint reduction, increased flexibility and high-purity solid dosage formulation with preserved biological activity, which would lead to the generalized reduction of the manufacturing costs and the wider use for mAbs and other biologic drugs, with beneficial effects also in the development of personalized medicine and the treatment of rare diseases with orphan indications.
Following the successful completion of the AMECRYS project, the final objective of the project has been matched, with the construction of a demonstration prototype and its fully operability demonstrated, proving the capability of TMC to produce significant quantities of crystals containing mAb, that can be easily scaled further with comparable results and continuously operated.
