Next-generation Biopharmaceutical Downstream Process
Laboratory of Catalysis and Chemical Reaction Engineering, National Institute of Chemistry is alongside with the Laboratory for Molecular Biology and Nanobiotechnology a research partner in Horizon 2020 (Biotechnology H2020-LEIT-BIO-2014-1)
Sub call of: H2020-BIOTEC-2014-2015
Main Pillar: Industrial Leadership
Topic: Downstream processes unlocking biotechnological transformations (BIOTEC-4-2014) Framework Programme-funded project with the acronym nextBioPharmDSP
Total project funding: 11 million eur
The underlying strategy for process development, which aligns the different molecular formats to the different unit operations and developed process schemes, will be established with the latest technology in terms of high throughput process development (HTPD) approaches together with enhanced model based process development. This enables modern quality by design (QbD) concepts and novel process analytical technology (PAT).
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Project abstract:
The scope of the project is the optimization of downstream processing (DSP) for the production of Biopharmaceuticals. Biopharmaceuticals have been successfully used as efficient therapeutic drugs for many pathophysiological conditions since the first recombinant product, insulin, was approved in 1982. Despite its efficacy, accessibility is still limited due to extremely high costs. In the production chain, capturing and purifying still represents a major bottleneck. Consequently, improvements in this area produce substantial cost reductions and expand patients’ accessibility to highly efficient drugs. Another aim of this action is to cope with the changing manufacturing demands, by lowering its environmental footprint and moving to more sustainable technologies. This proposal’s main objective is to implement a fully integrated manufacturing platform based on continuous chromatography in combination with disposable techniques for all unit operations of the DSP sequence for biosimilar monoclonal antibodies and derivatives thereof. The action encompasses the entire DSP sequence. We will implement alternative technologies for primary separation, such as flocculation or tangential flow filtration. The expected outcome is a reduction in the size and number of downstream unit operations and the elimination of centrifugation. Alternative approaches to the batch process for the capture step, such as continuous chromatography, will be evaluated in order to improve the efficiency and lower the need for expensive resin volume. Additionally precipitation utilization will be evaluated as an approach to replace protein A chromatography as capture step. A disposable continuous chromatography system will be developed together with novel analytical tools and sensors. Since single-use disposable systems can substitute the extensive use of resources (water) and significantly reduce the overall utility needs, the whole DSP sequence will be carried out on disposable technology.
This project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° [635557]