Search results for " leachables"
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Single-use systems involve a greater reliance on the quality and robustness of the vendor’s supply chain, and concerns about potential problems caused by extractables and leachables, especially during…
Article
Achieving Process Balance with Perfusion Bioreactors
It has also developed a biocontainer film that is both robust and flexible and offers a low and defined leachables profile. Adams notes that the company’s single-use bioreactors for perfusion also inc…
Article
Biopharma Seeks Balance
For example, industry groups championed efforts to address technical issues related to materials specifications and extractables and leachables, helping to accelerate the adoption of single-use system…
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
Article
Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
By Feliza Mirasol
zli…
Article
Process Development: What May Lie Ahead in 2018?
This article, Evaluating E&L Studies for Single-Use Systems, was one of the site’s most-read articles of 2017, as was a blog on how Cytiva aligned its extractables and leachables testing with the Biop…
Article
Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
…
Article
The New World of Biopharmaceutical Manufacturing
Top concerns are the potential for breakage of bags/loss of production materials and leachables and extractables (L&E) issues. Part of this persistent concern for L&E issues is the increased use of di…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …