Publication

Article

BioPharm International

BioPharm International-06-15-2019
Volume2019 eBook
Issue 2
Pages: 20–23

Extractables and Leachables: Determining Risk in Single-Use Systems

Author(s):

As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.

Single-use systems (SUS) are increasingly becoming the norm in biologics development and manufacturing. Approximately 85% of the pre-commercial biopharmaceutical sector use SUS, and they are increasingly being adopted for commercial manufacturing. SUS have significant advantages but are not without drawbacks. A 2018 survey showed that 73.3% of biologics insiders listed contamination from extractables and leachables to be a major problem.

Read this article in BioPharm International's Single-Use Systems 2019 eBook.

Article Details

BioPharm International
eBook: Single-Use Systems 2019
Vol. 32
June 2019
Pages: 20–23

 

Citation

When referring to this article, please cite it as A. Nixdorf, "Extractables and Leachables: Determining Risk in Single-Use Systems," BioPharm International Single-Use Systems eBook (June 2019).

Newsletter

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Related Videos
Behind the Headlines, Episode 23: Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet
© 2025 MJH Life Sciences

All rights reserved.