Search results for " identity"
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Article
Analysis of mRNA Therapeutics and Vaccines
Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.
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Virus-like Particles as Therapeutic Moieties of the Future
The identity of individual capsid proteins can be confirmed using Western blotting in conjunction with SDS–PAGE (1).
Reverse phase–high-performance liquid chromatography (RP–HPLC) is a frequently …
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
By: Pranav Vengsarkar and Nandu Deorkar
I…
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Mapping a Route for Cell and Gene Therapy Process Development
“A big challenge with allogeneic applications is making sure the identity and the quality of the final product is controlled within the design parameters of the process. Lack of adequate process chara…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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Automating the Biomanufacturing Process
As automation in biomanufacturing becomes more important, so does the need to integrate process data.
By Feliza Mirasol
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Biomanufacturing proc…
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Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
This update of a 2008 advisory describes how manufacturers should provide sufficient CMC information to assure the safety, identity, quality, purity, and strength/potency of investigational gene thera…
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Ensuring Viral Safety of Viral Vaccines and Vectors
MCBs should be tested for identity (phenotypic and genotypic, if recombinant) and purity. While FDA, the European Medicines Agency, and the World Health Organization guidelines differ, testing must de…