Search results for " techniques" in Articles / App Notes
Article
Bioprocessing Advances in Vaccine Manufacture
In the BioPlan study, vendors were asked if they provide sufficiently scalable single-use disposables and techniques. Overall, 53% of the industry considers scale to be a significant adoption restrict…
Article
Essentials in Establishing and Using Design Space
Design space is established through proper characterization techniques and is often an extrapolation of the response surface. Two-dimensional contour and three-dimensional surface plots are typically …
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
What this means is that there will, obviously, be extensive characterization of the biosimilar product using what the FDA refers to as state-of-the-art analytical techniques.” Levine adds that human c…
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PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Subsequent downstream purification has been accomplished using standard chromatographic techniques (36).
VIRAL VECTORS
Using viral vectors as BioTx for gene therapy offers many exciting oppor…
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Evaluating the Use of Continuous Chromatography
Advances in process analytical technologies and modeling techniques, however, may provide solutions to improving chromatography control for industrial-scale manufacturing (3). These advances offer opp…
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A Closer Look at Affinity Ligands
BioPharm: Why are affinity ligands preferred for biologics purification over other downstream purification techniques?
Elliot (BioCina): Affinity ligands can produce a very high purification facto…
Article
Discovering the unknown: How does in silico process development change PD scientists’ work?
Jeanne Linke Northrop: What should be kept in mind when someone is starting to work with mechanistic models, and, in general, in silico process development techniques?
Nora Ketterer: For new…
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Report from the 6th International HTPD Conference
Once again, the challenge of high throughput analytical techniques and assays was highlighted. Several analytical assays for AAV require high concentration of viral particles and therefore requires la…
Article
Top challenges in recombinant protein purification process development
So they have to use a combination of different techniques, and especially in this first step, they're not going to get the purity of this level.
Another challenge that they face is this slow devel…