Search results for "extractables" in Articles / App Notes
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…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
At this time, one area that is not currently regulated in detail by the health authorities is extractables and leachables. “Biopharmaceutical manufacturers have to establish ‘in-house’ risk-based stra…
Article
CMOs Concerned With Cost of Single-Use Equipment
The top two concerns for each group, for example, were “breakage of bags and loss of production” and “leachables and extractables”, with the former the most widely held among biomanufacturers and the …
Article
Trends in Single-use Bioreactors
Ang (Eppendorf): Leachables and extractables have recently been a big concern for single-use processes, especially those using polymer film bags. Even with the growing concern, suppliers are slow to e…
Article
Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis
Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
By Mario DiPaola, …
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
…oxicological perspective, as degradation products of stabilizers will be part of the leachables and extractables profile of a material. A recent reported example showed that the oxidized form of the …
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…