Collaboration looks to crystallization as alternative to multi-step chromatography

A European Union funded project to improve downstream processing is on track for completion by October 2020, says collaborator Fujifilm Diosynth Biotechnologies.

The AMECRYS research project, funded through a €3.5 million ($4 million) grant through the European Union’s Horizon 2020 program, has brought together industry with government and academic institutes to develop alternatives to multi-step batch chromatography platforms.

One of the collaborators is biologics contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies, which has reached a milestone in the project through the successful tech transfer of expression and purification of model monoclonal antibodies (MAbs) to the UK’s Centre for Process Innovation (CPI) – a government funded institute established to support the UK process manufacturing industry.

The AMECRYS research project is funded through a €3.5 million ($4 million) grant through the European Union’s Horizon 2020 program. Image: iStock/Rawpixel

“The aim of the project is to support new ideas and innovations that can improve downstream processing which has the potential to reduce production costs – which can also reduce the cost of life-changing therapeutics,” a Fujifilm spokesperson told BioProcess Insider.

“Current downstream processing relies on complex, inefficient and expensive separation stages, traditionally operated in batch-mode and primarily based on chromatography.”

Instead, the collaboration has looked at preparative crystallization as a cost effective and easily scalable purification alternative for the recovery of target products directly from clarified fermentation broths.

“The idea is to replace the multi-step process of chromatography-based platform with a single continuous membrane-crystallization unit in MAbs downstream processing – resulting in decreases across capital expenditure, operating costs and footprint.”

Collaboration

The project, which began in October 2016, is on track for completion in October 2020.

Along with the CPI and Fujifilm, the AMECRYS network involves public research organizations Consiglio Nazionale delle Ricerche and Centre National de la Recherche Scientifique, academic Institutions Imperial College London, Università del la Calabria, University of Strathclyde and Université Libre de Bruxelles, and life sciences filtration firm GVS S.p.A.

As part of a European Commission (EC) newsletter from September this year, Fujifilm explained why it joined the collaboration:

“As a contract development and manufacturing organization, Fujifilm Diosynth Biotechnologies is always interested in any innovative new technologies which have the possibility of improving our current production processes, or reducing the costs for our clients.”

“The membrane-based crystallization technique AMECRYS is employing has the possibility of resulting in a prototype disruptive technology for which FDB may become an early-adopter.”