Trends in Single-Use Biomanufacturing - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Trends in Single-Use Biomanufacturing

Pharmaceutical Technology Europe
Volume 26, Issue 8, pp. 40
PharmTech Europe 25th Anniversary
DSGpro/Getty Images;
Art direction: Dan Ward

Single-Use Technology—From Evolution to Revolution

Single-use technologies continue to evolve rapidly as more biopharmaceutical companies embrace the concept and start implementing single-use systems in their bioprocesses.

Single-use technologies have gained broad acceptance in biomanufacturing within the past few years, supporting flexible and cost-effective clinical production. Beyond this, first market productions in disposable equipment (e.g., Shire, Protalix) have already been approved in Europe and the United States. Currently, two thirds of all new bioprocesses are operated using single-use equipment. 1000-L single-use bioreactors (SUBs) represent the common standard; however, 2000-L SUBs are on the advance. In general, an optimistic growth market in the double-digit range is predicted (1).

Pharmaceutical Technology Europe
25th Anniversary Issue

Single-Use Systems: Enabling the Future of Biologics Manufacturing

Single-Use: Game-Changing Technology for the Biopharmaceutical Industry

What makes single-use facilities attractive, on the one hand, is the fact that implementation is cheaper and faster. The initial investment is approximately 40% lower in comparison to a stainless-steel facility at the same scale. Furthermore, the project lead time for implementation is reduced by at least eight months. On the other hand, the reduced risk of contamination in addition to the lower maintenance and energy costs result in higher process safety and operation efficiency. Finally, single-use facilities offer a high degree of flexibility in terms of product changeover and can be tailored to process scale.

In the near future, single-use facilities will be reshaped toward an even more modular design to meet increasing and varying demands. Further technological developments of single-use equipment, in particular centrifuges, process sensors, chromatography and membrane adsorbers, as well as new materials, will help to resolve operational limitations and address process and patient safety issues associated with leachables and extractables.

Cytotoxic leachables are particularly undesirable. For this reason, a screening with mammalian cell cultures in addition to the extractable studies established by the manufacturer is recommended (2). For depletion of the leachables, a risk-based approach that incorporates both manufacturer’s data and process data can be used. This approach guarantees that depletion is carried out within defined limits so that patient safety is ensured at all times.

1. E. Langer, R. Rader, Innovation in Stainless-Steel Bioprocessing, Life Science Leader, 31 Oct. 2013.
2. R. Eibl et al., Recommendation for Leachables Studies—Standardized cell culture test for the early identification of critical films.

Dethardt Müller
Dethardt Müller

About the Author
Dethardt Müller, is vice-president, Technology Development, at Rentschler Biotechnologie GmbH.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology Europe,
Click here