Low-pressure process chromatography could not have developed without immense efforts to resolve scale-up issues in both column design and matrix stability.
These articles encapsulate the past, present, and possible future of process-scale chromatography in biopharmaceutical production.
Biopharmaceutical processes typically require a significant investment in equipment-often a substantial obstacle for start-up companies. The risk of drug development failure is often high, further limiting access to the required capital. Flexibility and lower capital outlays are required not only by start-up companies, but also by research organizations with multiple product lines and by companies requiring quick capacity increases. Disposable technologies offer the highest potential for these companies to meet their business requirements. With lower capital requirements and increased flexibility, disposables are an important part of these companies' risk management strategy.
In a mere 30 years of development, a total of 23 MAbs and MAb-related proteins have been approved for medical treatments.
Revisiting simple, robust, and controllable technology is the only way to overcome these challenges.