Search results for " methods"
Article
Managing Residual Impurities During Downstream Processing
Test chapters that contain validated methods and associated reference standards facilitate method adoption following verification that they are suitable for a new purpose. Stakeholders are encouraged …
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Prerequisites for modeling
With the recent advancement of efficient numerical methods, it is feasible to create a complex and detailed mechanistic model that is capable of describing mass transfer…
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Selecting the Right Viral Clearance Technology
The success of viral clearance depends on the selection of appropriate methods that ensure the removal or destruction of any viruses without affecting the target protein. Several factors must be consi…
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Virus-like Particles as Therapeutic Moieties of the Future
For the former, frequently, membrane vesicles decorated with surface proteins co-purify with VLPs, which can be identified using high resolution structural methods, such as cryo-electron microscopy (c…
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The Importance of Partnering for Bioanalytical Studies
It is critical that the data [are]generated via phase-appropriately validated methods (i.e., the methods are ‘fit-for-purpose’) and in many cases adhere to Code of Federal Regulations (CFR), 21, Part …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
If the components within the formulation rinse at similar rates, then either non-specific methods, such as conductivity or TOC, or specific methods, such as ultra high-performance liquid chromatograph…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
The synthesis and purification unit operations of the process utilize equipment with programmed methods allowing scientists to complete their respective tasks. Manual crossflow filtration (CFF) steps …
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Ensuring Viral Safety of Viral Vaccines and Vectors
These methods primarily target the cell-culture medium before its transfer to the bioreactor as well as raw materials of animal or human origin. Options include high temperature/short time (HTST), C s…
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Development of Purification for Challenging Fc-Fusion Proteins
Lastly, the methods described here can be applied to the purification process development of other chromatography resins.
Materials and Methods
Purification techniques
…
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Patenting Prospects for Cell-Based Therapies
The nature of such therapies, and recent patent law trends regarding natural products and methods relating to the practice of medicine, suggest these therapies may not be given the type of robust pate…