Search results for "scale up"
Article
Science Focus Fuels Successful Process Development for Startups
Another issue for autologous cell therapies is the need to scale out, rather than scale up. When moving from preclinical to early clinical studies, the process must be scaled to work for one patient. …
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
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Article
Hybrid Bioprocessing: A Q&A with Andrew Sinclair
For the reasons discussed above, upstream scale out is often attractive as an option to scale up into SS. For downstream, it's less important and staying in a reusable SS format can often be cheaper w…
Article
Trends in Single-use Bioreactors
And although it is an increasingly less common need, single-use bioreactors do not scale up beyond 2000 L. However, end-users now are frequently choosing to scale out rather than up (multiple systems …
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
We also discuss scale up for processes where analytics intergrate with automation teams with the communications and networking teams. Balancing critical process parameters against competing requiremen…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
Scale up is another one where things go wrong. And like I said, a lot of times, that runs in with a tech transfer as well. When you get it up to a commercial scale, you’re starting to do big…
Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Modeling and miniaturization were two key take-home messages from the 4th High Throughput Process Development (HTPD) conference organized in October 2017 in Toledo, Spain. The conference brought tog…
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…