Search results for "extractables"
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
“In addition to leachable and extractables, there is also risk for nutrient loss by adsorption onto the plastic surface. These concerns can be addressed by screening these materials for compatibility …
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
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
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Paring Down Impurities in Downstream Processing
Myriad choices confront manufacturers before they even consider optimizing downstream processes. Each decision directly influences what final options will be available on arriving at the final…