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nextBioPharmDSP

Financiado

Cerrado

Next generation biopharmaceutical downstream process

The scope of the project is the optimization of downstream process (DSP) for the production of Biopharmaceuticals. Biopharmaceuticals have been successfully used as efficient therapeutic drugs for many pathophysiological condition... ver más

28/02/2019

LEK DD

11M€

Presupuesto del proyecto: 11M€

Líder del proyecto

LEK FARMACEVTSKA DRUZBA DD No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 7 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2019-02-28

BIOTEC-4-2014: Downstream processes unlocking biot...

I+D

Cerrada hace 10 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

7 Participantes

LEK DD

2.63M€ | Lider

NSYS

367.66K€ | Participante

NIC

660.38K€ | Participante

KIT

1.50M€ | Participante

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Duración del proyecto: 48 meses Fecha Inicio: 2015-02-11
Fecha Fin: 2019-02-28

Líder del proyecto

LEK FARMACEVTSKA DRUZBA DD No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 11M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto The scope of the project is the optimization of downstream process (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 (PAT).

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