Search results for " platform"
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Scalable Viral Vector Manufacturing
What are the main reasons for this rapid increase in viral vector manufacturing?
Viral vector platforms emerging at the crossroads of cell, gene therapy, and vaccines are becoming a promising ar…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
Specifically, Codiak is investigating the delivery of nucleic acids and engineering exosomes that, when combined with a platform production process, can become exosome drug therapeutics that are scala…
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Development of Purification for Challenging Fc-Fusion Proteins
Monoclonal antibody purification processes exist in different well-established platforms with extensive process performance histories for production of commercial mAbs (6-10), which typically consist …
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Unifying Continuous Biomanufacturing Operations
The two proposed platforms in that patent, however, used surge tanks, and in some embodiments of the invention, the use of a convective adsorption/desorption system was only semi-continuous (13). Whil…
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
An advantage in the area of mAbs is the possibility of using a purification platform approach. The typical platform process is generally comprised of an initial capture step with Protein A-chromatogra…
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Host-Cell Protein Measurement and Control
In late phase (Phase III or commercial), cell line-specific platform assay or upstream process-specific ELISA assay is often required to mitigate the risk associated with a more generic commercial ass…
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Continuous Manufacturing: A Changing Processing Paradigm
The platform flows a liquid culture medium from a perfusion bioreactor into a preliminary multi-column chromatography system (MCCS1), then the eluate of the MCCS1 containing the recombinant therapeuti…
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Challenges in Analytical Method Development and Validation
While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technologies for monoclonal antibody products, new molecules and drug conjugates pose additio…
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Top challenges in recombinant protein purification process development
But then there's also a good platform approach that can be used. So after your affinity step, you can use a combination of ion exchangers and the monoclonal antibodies will react quite similarly each …
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Given the reliability of platforms and the maturity of the industry’s understanding of quality, the most important business driver today is speed to market. One consequence of this emphasis on speed i…