Search results for " cell"
Article
E. coli growth and Dab expression in single-use and stainless steel fermentors
This application note describes the performance of the Xcellerex™ single-use XDR-50 MO stirred-tank fermentor in an E. coli domain antibody (Dab) production process developed for a stainless steel …
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Purifying these biological products once produced by cells requires a reliable and optimized chromatography process. An advantage in the area of mAbs is the possibility of using a purification platfor…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
Mammalian cultures do not tend to be intensive; they do not have high oxygen demand and do not grow in very high cell densities, Bird explains. In addition, the culture growth takes place over a long …
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Ensuring the Quality of Biologicals
Biologicals are those products derived from biological sources such as tissues and cell extracts, fermentation using micro-organisms, plasma, plants, or those produced by recombinant DNA technology. T…
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Modular Manufacturing Platforms for Biologics
The level of segregation between processing areas should be determined using a risk-based approach and should consider air handling, viral processing, live organism zones, and cell cultivation and cel…
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Technologies and Practices Must Evolve to Meet Demand
…and large-molecule therapies, and vaccines; more than 18% indicated that their organizations develop cell- or gene-based therapies.
The respondents reported that they were involved in many phases…
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Ligand-Binding Assays and the Determination of Biosimilarity
Consequently, functional assays, such as ligand-binding assays (LBAs) and mechanism of action (MOA) cell-based assays (CBAs), must be developed to effectively assess biosimilars. In many cases, LBAs a…
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Challenges and Trends in Biopharma Facility Design
…en could become cloneable facility platforms or enter into new production needs, for example for the cell therapeutic and personalized medicine market.
Kranjac (Cytiva): Beyond monoclonal antibod…
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Raw Material Variability
Raw materials have a wide definition: cell-culture media; excipients; chemical additives; detergents; manufacturing process agents, for example, anti-foam agents or even product contact materials like…
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Bioprocessing Advances in Vaccine Manufacture
These advances include:
•Single-use systems (SUS)/disposable bioprocessing systems
•Modular/transportable bioprocessing facilities
•Novel expression systems/improved cell lines
…