Search results for " control" in Articles / App Notes
Article
A Q&A With Jeff Carter on Trends in Single-Use Technologies
This will help to address one of the industry’s top concerns – that single-use materials need to be effectively controlled and characterized so as to properly understand their potential impact on proc…
Article
Framing Biopharma Success in 2016
The goal is to educate FDA staff about the new technologies in advance of chemistry, manufacturing, and controls (CMC) submission, thereby expediting the approval process.
Quality warning signs
…
Article
Biopharma in 2015: A Year for Approvals and Innovations
…ent inoculum propagation in perfusion culture using WAVE Bioreactor™ systems
The Use of Dynamic Control in Periodic Counter-Current Chromatography
Purification Strategies to Process 5 g/L Titer…
Article
Biacore Concentration and Ligand-Binding Analyses
During development and in quality control, a range of analytical technologies are used to characterize biotherapeutic drugs in terms of their structural integrity and activity. In this white
paper, …
Article
GMP Challenges for Advanced Therapy Medicinal Products
“Manipulation of cells and use of recombinant nucleic acids may bear unknown risks, which may not be solvable through standardization or quality control,” Salmikangas added.
A major problem area wi…
Article
Selecting the Right Viral Clearance Technology
Taking a holistic approach is the most effective means of achieving viral control, according to Riske. “While traditionally viral clearance has been achieved during the downstream processing of biopha…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Smart Bioprocessing has been chosen as the theme to emphasize the importance of understanding and controlling the origin of impurities, the impact of the production sources considered for the process,…
Article
The Metrics of Quality Culture
Quality systems metrics might look at change control, investigation root-cause trends, and release-testing cycle times.
There is no set requirement on which metrics a company should track to measu…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
Moreover, the company failed to put in place intra-campaign controls aimed at verifying that during a production campaign the level of potential degradation residues in the equipment was maintained to…
Article
Breakthrough Drugs Raise Development and Production Challenges
Effective communication with contract manufacturers is crucial, as is a transparent presentation in the application of design evolution and a rationale for commercial manufacturing process and control…