Search results for " method"
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 …
Article
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…
Article
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
NTA offers a non-invasive method to quickly analyze size distribution, identify aggregates, and calculate the concentration of particles (20). It is to be noted that enveloped, pleomorphic VLPs typica…
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The Importance of Partnering for Bioanalytical Studies
…al studies?
Kernstock (ICON): For any regulated bioanalytical study to occur, a validated method is required. FDA has issued guidance documents detailing the scope of bioanalytical method valid…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
The process typically involves performing 100% spray coverage testing, rinse recovery testing, specific or non-specific analytical method qualification, surface sampling and recovery testing of the sa…
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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 …
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
…ectors for gene therapy, and highlights a holistic risk-mitigation approach of testing and clearance methodologies to help prevent contamination events.
Viral safety strategy and regulatory
…
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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
…
Article
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…