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Next-generation biopharmaceutical downstream process

Objective

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).

Field of science

  • /natural sciences/biological sciences/biochemistry/biomolecules/proteins
  • /social sciences/economics and business/economics/production economics

Call for proposal

H2020-LEIT-BIO-2014-1
See other projects for this call

Funding Scheme

IA - Innovation action

Coordinator

LEK FARMACEVTSKA DRUZBA DD
Address
Verovskova Ulica 57
1526 Ljubljana
Slovenia
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 2 631 737,50

Participants (6)

MILLIPORE SAS
France
EU contribution
€ 1 700 499,50
Address
39 Route Industrielle De La Hardt
67120 Molsheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITAET FUER BODENKULTUR WIEN
Austria
EU contribution
€ 1 181 063
Address
Gregor Mendel Strasse 33
1180 Wien
Activity type
Higher or Secondary Education Establishments
Sandoz GmbH
Austria
EU contribution
€ 328 475
Address
Biochemiestraße 10
6250 Kundl
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
KARLSRUHER INSTITUT FUER TECHNOLOGIE
Germany
EU contribution
€ 1 496 625
Address
Kaiserstrasse 12
76131 Karlsruhe
Activity type
Higher or Secondary Education Establishments
KEMIJSKI INSTITUT
Slovenia
EU contribution
€ 660 375
Address
Hajdrihova 19
1000 Ljubljana
Activity type
Research Organisations
NATIONAL SYSTEMS SRL
Italy
EU contribution
€ 367 657,50
Address
Via Goito 60
21019 Somma Lombardo Va
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)