Uwe Gottschalk, PhD

As constant scale up grows out of favor in the biopharmaceutical industry, new-and old-approaches are required. The author reviews the state of downstream processing and considers potential solutions, including the streamlining of full processes and borrowed technologies

Uwe Gottschalk, vice-president of purification technologies, Sartorius Stedim Biotech, discusses specific challenges in protein purification.

The industry needs to embrace innovation to improve the efficiency and robustness of biopharmaceutical purification without driving up the cost of goods.

The author reviews the state of downstream processing, including a look at the streamlining of full processes and borrowed technologies.

This summary provides an introduction to our special issue on Separation and Purification.

An analysis of flow rate, load density, viral clearance, and cost.

A membrane adsorber in retention mode can be used efficiently in a commercial antibody manufacturing process.

STIC allows polishing to be carried out without an interstitial dilution step, which reduces process time and avoids additional buffer preparation and hold steps.

Results from a process developed for a commercial antibody.

To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors.

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.