Search results for "Recovery"
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Downstream Processing for Cell-Based Therapies
Using TFF and EBC, Cunha and colleagues showed high protein clearance (98%), high recovery of viable hMSCs (70%) with no impact on cell viability (95%) or other CQAs (morphology, immunophenotype, prol…
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Microbiological Testing: Time is of the Essence
In addition, the many different matrices of the different in-process samples lead to challenges with recovery of different organisms depending on the process step,” he explains.
Next-gen therapies …
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Accuracy was determined by calculating the percent recovery of glucose spiked in CDS culture medium at concentrations ranging from ~50% to ~150% of the glucose concentration in each medium. The spike …
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Productivity
The productivity, expressed as amount of product per unit of time and unit of chromatography media, is determined by the breakthrough capacity of the chromatography media, the recover…
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Host-Cell Protein Measurement and Control
FDA expects “Whenever possible, contaminants introduced by the recovery and purification process should be below detectable levels using a highly sensitive analytical method” (7). The European Medicin…
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Bracing for a Future Wave of Advanced Therapies
FDA Approves Omidubicel to Reduce Time to Neutrophil Recovery and Infection in Patients with Hematologic Malignancies. Press Release, April 17, 2023.
3. FDA. FDA Approves First Topical Gene Ther…
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A deep dive into optimizing AAV capture and polishing to maximize both yield and purity
The affinity capture step maximizes recovery and efficiently removes impurities.
Join this webinar to:
• Learn how to optimize affinity capture
• Discover critical parameters that enhance f…
Article
Digitalization: The Route to Biopharma 4.0
Data-driven models have been used for predicting product recovery and optimization (8). Recently, a hybrid modeling approach, combining both mechanistic modeling and data-driven modeling, has been sho…
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High-concentration monoclonal antibody drugs: manufacturing challenges
Solutions that maintain quality, maximize process yield and product recovery are available and can be introduced to adapt an existing manufacturing platform to the new process requirements.
Downloa…
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Developing a HIC polishing step for removal of mAb aggregates
…on to identify the robust conditions to reach the objectives in aggregation removal and the monomer recovery.
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