Search results for " control"
Article
Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Platform Approach Speeds Process Development
Next, a variable number of cultivation parameter screening and optimization studies are performed in controlled bench-scale bioreactors including DoE approaches. Process fixation and process consolida…
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Continuous Processing for the Production of Biopharmaceuticals
The success of continuous manufacturing technologies relies highly on the utilization of real time analytical tools coupled with superior control strategy. The implementation of process analytical tec…
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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…