Search results for " control" in Articles / App Notes
Article
Ensuring the Biological Integrity of Raw Materials
Protocols for control of contamination in raw materials rely on cleaning and decontamination procedures combined with rigorous testing. These procedures are effective for most agents, but some organis…
Article
Evaluating E&L Studies for Single-Use Systems
…will occur; and the probability of detecting the leached substances through in-process manufacturing controls.
The risk analysis of each product contact material used in the process takes into ac…
Article
High-Throughput Process Development Handbook
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. Employing high-throughp…
Article
Process Chromatography Selection for Downstream Processing Applications
Also, the ability to use concentrated buffer components and mixing them in-line under controlled conditions (in-line conditioning) has simplified the chromatographic operation. Other simplifications a…
Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Demand for custom formulations and packaging have increased, as has customer demand for quality control reports.
Several suppliers reported facility expansions to increase capacity for these vital…
Article
Innovative Therapies Require Modern Manufacturing Systems
The development of new antibiotics gained from several spending provisions: in addition to $100 million to NIH for that purpose, the Centers for Disease Control and Prevention (CDC) received $160 mill…
Article
Antibody Production in Microbial Hosts
Further, mAb production in microbial hosts such as bacterial cells completely abrogates the nuisance of glycosylation control and speeds up production timelines, further simplifying bioprocessing. The…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Cell lines are cultured, passaged, and processed in and among laboratories with widely varying quality control (QC) procedures, while sharing cell lines is endemic--particularly in academia. For these…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
QC is quality control.
Regulations evolve
Cell therapy is still a new area for regulators, and, as Preti says, some guidelines are clear and others aren’t. “Development by design is need…