Search results for " impurities" in Articles / App Notes
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Have the end in mind
Such things as formulation issues, dosage potency, impurities, residuals, and microbial assurance need to be thought out clearly from the start, Hampson says, as well as indic…
Article
USP Stresses Pharmacopeial Standards at CPhI China
The USP requirements for elemental impurities, FDA’s metrics program, and the generic-drug market were also discussed.
USP stressed the need for compliance with global regulations and standards du…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
Improving PAT for Biologics
The increased use of PAT for upstream processes is driven by the fact that most of the critical quality attributes of a product, the product yield, and the quantities of process-related impurities are…
Article
Trends in Single-use Bioreactors
• The issues of extractables and/or leachables and the potentially negative impact these impurities can have on specific processes
• The need for additional warehousing and associated logistics to…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…
Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
“This characterization should include the determination of physicochemical and immunochemical properties, biological activity, purity, impurities, and quantity of the mAb, in line with ICH Q6B guideli…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
…molecular weight (MW) species, and the formation of degradation products, such as protein clips, and impurities. Today, SEC is predominantly used to measure aggregation, because the determination of …
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Furthermore, the use of bioreactors ensures a closed, sterile, controlled environment, and thus the risk of potential impurities is reduced. As a result, Novartis’ Flucelvax vaccine does not contain a…