From Discovery to Production: Challenges and Novel Methodologies for Next Generation Biomanufacturing

TL;DR

This paper discusses the challenges and innovative methodologies in biomanufacturing, emphasizing the shift towards flexible, continuous production processes supported by operations research to accelerate drug development and manufacturing.

Contribution

It introduces new operational research methods for designing and controlling next-generation biomanufacturing processes, addressing current industry challenges.

Findings

Identification of key technical challenges in modern biomanufacturing

Proposal of novel process modeling and control approaches

Insights into enabling flexible and rapid drug production

Abstract

The increasingly pressing demand of novel drugs (e.g., gene therapies for personalized cancer care, ever evolving vaccines) with unprecedented levels of personalization, has put a remarkable pressure on the traditionally long time required by the pharma R&D and manufacturing to go from design to production of new products. The revolution has already brought important changes in the technologies used within the industry. In fact, practitioners are increasingly moving away from the classical paradigm of large-scale batch production to continuous biomanufacturing with flexible and modular design, which is further supported by the recent technology advance in single-use equipment. In contrast to long design processes, low product variability (one-fits-all), and highly rigid systems, modern pharma players are answering the question: can we bring design and process control up to the speed that novel production technologies give us to quickly set up a flexible production run? In this tutorial, we present key challenges and potential solutions from the world of operations research that can support answering such question. We first present technical challenges and novel methods for the design of next generation drugs, followed by the process modeling and control approaches to successfully and efficiently manufacture them.