Search results for " stability"
Article
Re-use of Protein A Resin: Fouling and Economics
The high selectivity is accompanied by reasonably good physiochemical stability. The Protein A ligand has been attached to a large variety of different base matrices such as cross-linked agarose, surf…
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Predicting Progress in Protein Aggregation
Other factors that have been used to develop these models include the unfolding kinetics and the thermal and colloidal stability of native proteins. The properties of the peptide segments of interest …
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Development of validated stability-indicating assay methods—critical review. J Pharm Biomed Anal. 2002;28:1011–40.
14. ICH. Q2(R1), Validation of analytical procedures: text and methodology. Genev…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
The first two chromatography steps were performed in the cold to maintain product stability.
Case study 2.
During development of an early-phase purification process for an acidic Fc-fusion pro…
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Address the complexity of protein characterization
… target binding, and describe how you can use these assays for assessment of drug potency (EC50) and stability.
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
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Moving Biosimilars Forward in a Hesitant Market
[Companies] have to establish more steps, and need to have much more stability data available to show that [the biosimilar] product is actually doing what it is supposed to do,” Bukhari explains.
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Dear lentivirus: We have not forgotten about you and how to improve your polishing recovery
Vector purification is very challenging due to low stability of these enveloped viruses, which are sensitive to low pH, high salt, temperature, shear forces, and other factors.
To maximize physica…
Article
Optimizing your Cell Culture Process to Improve Productivity
Cell Culture Process
In this video, Mary Szorik and Alicia Elwood at Cytiva, discuss the rationale for cell culture and analytical testing as well as the types of tests that can lead …
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Evolving demands of process development services
The final trend that is being seen and, in some ways is linked to the challenges of the pandemic, is the requirement of a partner who can ensure supply chain stability with a robust continuity busines…