Search results for "doe"
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
What it does demonstrate, however, is that using the aforementioned QbD model, the CMO portion of the product commercialization is unlikely to ever be the bottleneck for a commercialization timeline. …
Article
Selected courses from cell culture and downstream process development to scale-up and manufacturing
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Bioreactor scaling
Filtration in bioprocessing
Purification of mAb variants
DoE in protein purification
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Article
Process Development for Viral Vectors
Scaling viral vector processes can be challenging, but it doesn't have to slow you down. Cytiva can help you own your process and gain valuable expertise. Download a case study from Fast Trak™…
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Developing a HIC polishing step for removal of mAb aggregates
It includes:
- The use of HTPD plates to select the optimal resin as well as running conditions
- The use of a design of experiments (DoE) to optimize the running conditions
- A Monte Carlo simul…
Article
Webinar: Optimizing a HIC step with HTPD
This workflow includes the use of high-throughput process development (HTPD) plates to facilitate the choice of resin and initial conditions for column chromatography, and a design of experiments (DoE…
Article
How Well Do You Know Process Development?
DoE. Process understanding. Check your mastery of these and other essential terms by taking this quick quiz.
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Article
Report from the 12th Plasma Product Biotechnology Forum
In this case study a normal DoE approach was deemed too challenging due to the high number of different starting materials resulting in an extremely high number of experiments. Such limitations were e…
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Accelerating VLP purification process development
The development of a purification strategy is a mainly experimental approach where parameters are optimized via Design-of-Experiment (DoE) studies. Dozens of experiments are needed to screen a process…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Ideally, you want everything smooth and running right down the middle of your intended process parameters, but if something doesn't go that way, it shows up in the trends of the process analytical tec…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
What does a quality unit entail? It's just not two guys and a bunch of standard operating procedures. There’s a lot more to it than that. I've seen that being a big stumbling block for some companies.…