Search results for " optimization" in Articles / App Notes
Article
Evolution of the Monoclonal Antibody Purification Platform
As shown below, while the primary recovery module is kept as part of the flow scheme, it requires optimization to work with increased solids density, media components, and other metabolites. On the ot…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
Article
Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
Life-sciences companies face more pressure than ever to reduce costs and increase eff…
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Essentials in Establishing and Using Design Space
Set point selection and robust optimization within the design space
Once the model has been generated, optimization of all set points to find the most robust (stable) area within the design sp…
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Regulatory Challenges in the QbD Paradigm
The inspection team would review documents that present and justify the control and optimization of such important aspects of product quality assurance.
The emphasis of inspection would be on i…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.
ABSTRACT
The use of small-interf…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Article
From Bottlenecks to Breakthroughs: Mastering Buffer Management
Unlock innovation in manufacturing by optimizing your buffer production.
Agenda
- Options to intensify buffer preparation from using pre-made buffers or buffer concentrates to impl…
Article
Recap: Chromatography + filtration virtual summit 2024
Did you miss the Chromatography + filtration virtual summit 2024? Don’t worry – here are the highlights and session recordings from the event on optimizing purification and filtration for mAbs…
Article
Alternative solutions to separate AAV full and empty capsids using anion exchange
Adeno-associated virus (AAV) is the main vector for gene therapy and there is need for scalable, cost-efficient, and robust chromatography-based purification. Key for a successful process are …