Search results for " leachables" in Articles / App Notes
Article
Unifying Continuous Biomanufacturing Operations
Also, Klutz and team admitted the single-use equipment they used in the paper was meant for fed-batch, so no analysis of extractables and leachables was conducted; this analysis would typically be a n…
Article
Extractables Studies for Single Use Systems Used in ADC Manufacturing, Part 1
The use of organic solvents in the ADC process might , however, raise questions about potential leachables from the plastic and elastomeric materials of single‑use components. To address those conce…
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
To assist the adoption of single-use systems, industry organizations, such as the BioPhorum Operations Group and Bio-Process Systems Alliance, are addressing concerns about extractables and leachables…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
There were also new, related challenges, such as an increased sensitivity of animal-component-free cultures to toxic contaminants, metabolic waste products, or leachables from polymers used in single-…
Article
Design and Qualification of Single-Use Systems
BPSA, Component Quality Test Matrices, Gamma Irradiation and Sterilization, Extractables and Leachables, Particulates, Quality Agreement Template, www.bpsalliance.org
8. PDA, Technical Report No. …
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Testing of plastic components for extractables and leachables, as well as performance and consistency from multiple suppliers, was a popular topic. The need for harmonized standards was emphasized, bu…
Article
Using Single-Use Technologies in Downstream Processing
Challenges of SUS in Downstream Processing
BioPharm: What specific challenges do manufacturers face when using single-use systems in downstream processing?
Mehta: Extractables and leachables a…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Iss…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
…re have historically been concerns regarding the evaluation of plastics in terms of extractables and leachables. “These concerns have, however, been successfully addressed by single-use suppliers thr…