[SCAN] Overcoming the challenges in biopharmaceuticals manufacturing: A model-based approach for downstream process development

Scan Seminar

Title: Overcoming the challenges in biopharmaceuticals manufacturing: A model-based approach for downstream process development

Speaker: Ricardo Silva

From: Engineering Cellular Applications Lab, ITQB

Abstract
The new generation of biopharmaceutical products present major engineering challenges for large-scale production. Demands for high-production yields, resolving power, efficiency, and the increasing regulatory requirements at the downstream processing, make this manufacturing step account for 50-80% of the total processing cost with a significant part attributed to chromatographic processes.
Optimization of downstream processing strategies is currently considered the central element in appropriate process design. The narrowing of the process design space is normally determined by the stringent product quality requirements dictated by regulatory agencies and the shortness of the time-to-market. Consequently, the design and development of a purification process for a new biopharmaceutical is mostly carried out empirically, relying heavily on heuristics-based expert knowledge and on numerous trial-and-error experiments, often resulting in overall suboptimal processes with low specific/volumetric productivities and low raw materials-to-product yields.
A new approach and increased research effort should be allocated not only to the fundamental and deterministic understanding of downstream processes and related subjects, but also on the development of applications towards a more efficient manufacturing. In this sense, moving away from single-column batch operation towards continuous, or semi-continuous, multicolumn chromatography will potentiate an increase in productivity and flexibility of downstream process with the added advantages of footprint and equipment scale reduction.