Search results for " efficiency"
Article
Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …
Article
Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
Article
Reducing Cross-Contamination Risks in Process Chromatography
Preparatory and post-processing steps such as column packing, validation of packed-bed efficiency, verification of endotoxin clearance, unpacking, cleaning of unpacked columns, etc., can also be elimi…
Article
Platform Technologies Improve Protein Expression
Improving efficiency, yield, and functionality
There are a large number of factors to be taken into account in the development of new platform technologies for protein expression ranging from the …
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
Article
Mixing dynamics in a large volume single use mixer
Large-volume mixers are mainly required in clinical three-scale and production-scale facilities where mixing efficiency is one of the key drivers of throughput efficiency. Upstream applications such …
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Generating a Fully Processed Antibody
High gene insertion efficiency
The ability to efficiently insert genes into cells makes balancing ratios of protein expression a much easier process and shortens timelines. Complex protein molecul…
Article
Platform Approach Speeds Process Development
… becomes an issue because the drug substance must be produced in large quantities with cost and time efficiency to meet clinical requirements and pave the way toward commercialization.
Within the…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…