Search results for " process" in Articles / App Notes
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
“This means several things, including how the materials and personnel will flow throughout the facility (unidirectional) and how unit operations (individual processing steps) will be combined to build…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Particularly for Fc-fusion proteins, these improvements have resulted in a new set of starting conditions for downstream processing, including elevated levels of high molecular weight species (HMWs; u…
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Taking a “Development-by-Design” Approach to Cell Therapies
This has been traced to problems with manufacturing and failure to understand process requirements earlier in the development process. Table I outlines manufacturing issues.
As a growing number of…
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Tools for Continuous Bioprocessing Development
Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations…
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Trends in Single-use Bioreactors
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McNeil (Thermo Fisher Scientific): We have seen several advancements in single-use sensors and process analytical technologies to use with single-use bioreactors. In addition, there are improve…
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Eliminating Residual Impurities Starts with a Strategic Plan
It also allows the development of an optimal process with a suitable control strategy and test methods in a timely fashion.
The implementation of a risk-based strategy for the testing of residua…
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New Therapies Present Scaling Challenges
For a gene therapy, some aspects of its manufacturing process can use a scale-up strategy similar to a mAb, but other aspects of its manufacture cannot be easily be scaled up.
The cell therapy ch…
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Q&As with Industry Leaders
Jeanne Linke Northrop, BioPharm International
Nora Ketterer, Manager, Modeling Services, Cytiva
Top Tips for Successful Development of Antibody Chromatography Processes
Jeanne L…
Article
Reconciling Sensor Communication Gaps
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors and probes. Single-use systems …
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Best Practices in Qualification of Single-Use Systems
When end users actually implement SUS in cGMP biomanufacturing processes, however, there are still many challenges including the following:
• Lack of thorough understanding of new materials (e.g.,…