DOWNSTREAM PROCESSING

Purification approaches and platforms for next generation therapeutics 

Complex molecular formats of biologics are becoming increasingly common invaccines, cancer and immunotherapies. New approaches to purification, downstream technologies andfacility design can facilitate the purification of these complex molecules while also making operations more cost effective. We will be comparing various case studies and new technologies for specific applications,and managing more complex modalities. From cell and gene therapies to ADCs and blood factors we willbe looking at how to optimise bioprocess for every application.

Advances in chromatography and novel purification methods 

The major cost factor in purification is using “protein A” affinity chromatography where tens of thousands of litres of culture volume have to be processed annually. About 80% of the production costs fall upon purification. However, new purification methods are finally coming into play.

PAT, Process modelling, monitoring and control 

In the past decade, the FDA’s process analytical technology (PAT) and Quality-by-Design (QbD) initiatives have been major drivers for developing well-understood, robust processes for assuring reproducible pharmaceutical product safety and efficacy. As a result of these factors, industry trends are moving toward the implementation of automated PAT strategies that are designed to bring analytics closer to the operation, eliminate gaps in real-time process monitoring, and develop a more rapid, deeper understanding of the bioprocess.

Pioneers speaking on this topic include