By Gary Skarja, MilliporeSigma
There is unprecedented pressure on the biopharmaceutical industry to improve the performance of monoclonal antibody (mAb) development and manufacturing processes. There are several factors essential to addressing this challenge, including flexibility (in which product changeover time is reduced), quality (as defined by increased robustness and reliability), speed (in which production and product release are accelerated), and cost reductions in manufacturing and capital expenditure.
Improvements in processes and productivity can enable smaller and simpler facilities and lower costs, leading to several advantages, including the ability to:
- Improve competitiveness and long-term sustainability
- Enable business models for new biologics and novel therapies
- Supply developing countries with affordable biologics
- Reach emerging markets profitably
A key strategy for delivering higher productivity and enabling more flexible manufacturing processes is the adoption of single-use technologies. We’ve witnessed major improvements in upstream processes with single-use bioreactors and perfusion strategies that can deliver significantly higher titers. In parallel, single-use approaches are being incorporated in downstream processes, including clarification, tangential flow filtration, virus filtration, and final fill. Due to a lack of more productive and efficient alternatives, the use of low-throughput chromatography processes requiring large and expensive units has continued, preventing implementation of a fully single-use downstream flow path.