Search results for " leachables"
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
Single-Use Technologies Prove Effective for Viral Vector Process Development
For instance, Cameau notes that leachables and extractables remain a concern any time single-use technologies are implemented. In addition, more understanding is needed regarding how the upstream manu…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
By: Pranav Vengsarkar and Nandu Deorkar
I…
Article
A Plastic Pipeline for Commercial Bioprocessing?
The potential for extractables and leachables contamination from the plastic materials is one argument against using single-use products. Efforts by industry groups to establish and standardize testin…
Article
A Q&A With Jeff Carter on Trends in Single-Use Technologies
There is a lot of discussion on standardization on Extractables & Leachables (E&L) studies. How do you see this is evolving?
There are two things that are happening in parallel. BPOG created a sta…
Article
Fluid Handling in Biopharma Facilities
Butler (AdvantaPure): Concerns include pH shift, evaporative and absorptive losses, loss of bag integrity due to handling, and leachables.
Peuker (Sartorius Stedim Biotech): Bigger volume means hig…
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Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
“The storage container environment plays a role too; studies in prefilled syringes show that silicone oil, leachables from the rubber stopper, and glass delamination can induce aggregates.” Denaturati…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
…a chemical and toxicological 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 oxidi…
Article
Extractables in Single-Use Systems Used in ADC Manufacturing, Part 2
We performed extractables studies on single-use chromatography and tangential flow filtration systems using common solvents in ADC manufacturing, DMA and DMSO. The low levels of extractables f…