Cristina Peixoto Keynote

Cristina Peixoto
Head of the Downstream Process Development Laboratory
Instituto de Biologia Experimental e Tecnológica (iBET), Portugal
peixoto@ibet.pt

Improving downstream process of new biopharmaceuticals using non - traditional chromatographic strategies

The advanced therapies in the biopharmaceutical industry has moved the spotlight into complex products such as virus based biopharmaceuticals or stem cells, holding great promise in a myriad of clinical targets. Currently, the challenge for a widespread application of these new biopharmaceuticals is the development of cost-effective bioprocesses while maintaining product's bioactivity and quality attributes. This presentation will focus on several case studies on downstream purification of cell and virus based products, supported by process innovation and the flexibility of old, but robust technologies.
Improvement of purification yields of virus based biopharmaceuticals can be achieved through the rational development of alternative strategies, combining different modes of operation, together with the recent developments of new chromatographic media and fundamental understanding of the adsorption phenomena as reported for the case of gene therapy medicinal and vaccination products. A particular focus will be given to the use of membrane chromatography for purification of new Influenza vaccine enabling to speed up the process by decreasing the number of DSP steps, to improve the scale-up and to reduce costs due to the removal of other traditional chromatographic steps.
Critical quality attributes of cell based medicinal products cannot be compromised by the processing route chosen. The use of the already established TFF technology has the potential to improve the purity of cell based products, with the evaluation of critical process parameters of cell concentration and washing being of paramount importance. The purity of such products can also be incremented with the use of negative mode expanded bed adsorption chromatography with a new multimodal prototype matrix based on core–shell bead technology as demonstrated for the case of human mesenchymal stem cells.
In summary, the advancement of the purification of complex biopharmaceutical entities, such as the ones here reported, can be described as an incremental process, but still with space for innovation.