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Revolutionising Downstream Processing of Monoclonal Antibodies by Continuous Template-Assisted Membrane Crystallization

Objective

Separation and purification of biopharmaceuticals is today one of the most time and cost intense Downstream Processing (DSP) operations in the manufacture of commercial products. Separation and purification of proteins is usually achieved chromatographically, with all of its disadvantages including high buffer requirements, large footprint, reuse and storage of resin studies as well as costs. Traditional DSP based on batch chromatography contribute ca. 66% of the total production cost of anti-cancer monoclonal antibodies (mAbs). Largely contributing to this is the cost of chromatography media; for instance, the cost of 1 L of protein A resin with binding capacity of 20-70 g mAb is about 25000 Eur. By a visionary and ambitious combination of the emerging Continuous Manufacturing Paradigm with innovative Membrane Crystallization Technology and the selective nanotemplate-recognitions directly from the fermentation broth, the AMECRYS Network aims to develop a new Continuous Template-Assisted Membrane Crystallizer in order to revolutionize the DSP platform for mAbs production, thus achieving unprecedented purification and manufacturing efficiencies. Major research challenges will include: i) the synthesis of 3D-nanotemplates with specific molecular recognition ability towards mAbs from complex solutions; ii) the development of tailored macroporous fluoropolymer membranes for advanced control of selective heterogeneous nucleation; iii) the design of multilevel microfluidic devices for high-throughput mAb crystallization screening in a wide range of conditions under continuous flow (“pharma-on-a-chip” concept); iv) technology scale-up to a L-scale continuous prototype designed with recognition of QS/GMP compliance for biopharmaceuticals. The replacement of chromatography with a single membrane-crystallization unit will lead to >60% CapEx and O&M costs decrease, 30-fold footprint reduction and high-purity solid formulation of mAbs with preserved biological activity.

Call for proposal

H2020-FETOPEN-2014-2015-RIA
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Coordinator

CONSIGLIO NAZIONALE DELLE RICERCHE
Address
Piazzale Aldo Moro 7
00185 Roma
Italy
Activity type
Research Organisations
EU contribution
€ 608 073,75

Participants (8)

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE
United Kingdom
EU contribution
€ 368 125
Address
South Kensington Campus Exhibition Road
SW7 2AZ London
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DELLA CALABRIA
Italy
EU contribution
€ 375 000
Address
Via Pietro Bucci 7/11/B
87036 Arcavacata Di Rende
Activity type
Higher or Secondary Education Establishments
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
EU contribution
€ 274 115
Address
Rue Michel Ange 3
75794 Paris
Activity type
Other
UNIVERSITE LIBRE DE BRUXELLES
Belgium
EU contribution
€ 299 375
Address
Avenue Franklin Roosevelt 50
1050 Bruxelles
Activity type
Higher or Secondary Education Establishments
UNIVERSITY OF STRATHCLYDE
United Kingdom
EU contribution
€ 335 500
Address
Richmond Street 16
G1 1XQ Glasgow
Activity type
Higher or Secondary Education Establishments
CENTRE FOR PROCESS INNOVATION LIMITED LBG
United Kingdom
EU contribution
€ 705 015,46
Address
Wilton Centre Wilton
TS10 4RF Redcar Cleveland
Activity type
Research Organisations
GVS SPA
Italy
EU contribution
€ 291 250
Address
Via Roma 50
40069 Zola Predosa
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED
United Kingdom
EU contribution
€ 277 359,54
Address
Belasis Avenue
TS23 1LH Billingham
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)