Search results for "extractables"
Article
Quality by Design and Extractable and Leachable Testing
Extractables of concern are highlighted and targeted in the leachable study. Not all extractables are leachables, but because it is not always clear which components could leach out under storage cond…
Article
Extractables Studies for Single‑Use Systems Used in ADC Manufacturing
To address those concerns, extractables studies were
performed on disposable chromatography column housings and disposable flow paths provided by Cytiva. The extractables studies were performed wi…
Article
Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious. In this environment, BPOG has published a proposal for such a standard appr…
Article
Evaluating E&L Studies for Single-Use Systems
Suppliers are advised by the BioPhorum Operations Group (BPOG) and Bio-Process Systems Alliance (BPSA) to provide comprehensive extractables test data. Many companies have now adopted the BPOG extract…
Article
Advancing Single-Use Technology Through Collaboration
Concerns such as extractables and leachables, visible particulate contaminants, and system integrity may prevent some manufacturers from more widespread adoption of single-use technology. Industry gro…
Article
Best Practices in Qualification of Single-Use Systems
For buffer filtration and storage, the SUS should be sterile, not present any concerns for extractables/leachables, and not leak. For the SUS in fill and finish, it should be sterile, not present any …
Article
Use of Multivariate Data Analysis in Bioprocessing
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
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 …
Article
Design and Qualification of Single-Use Systems
…ces document, along with supplemental BPSA guides with specific recommendations on qualification of extractables, sterilization, and particulates testing (7). Additional tests for SUS qualification h…
Article
Aseptic Processing: Keeping it Safe
New product contact materials or components are generally tested for extractables under exaggerated-use conditions of solution composition, temperature, and time of contact, says Singh. “Preferably, t…