Search results for " comparability"
Article
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…
Article
Good Manufacturing Practices: Challenges with Compliance
Specifically, the ability to use comparability data to implement new technologies with limited regulatory burden would be helpful to ultimately improve the quality of products. While there are some pr…
Article
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options. …
Article
Flexible Facilities for Viral Vector Manufacturing
Single-use and modular systems will meet demand for rapid implementation at different scales.
By Jennifer Markarian
Industry experts have noted that there are limitations in the…
Poster
Comparison of Three Different Screening Techniques for Predicting Step Elution Conditions for a Cation Exchanger
Screening of chromatographic conditions can be done in several ways, such as 96-well plates, mini-columns, and tips. It is important that the screening can give an indication of the optimal conditio…
Article
Increasing Productivity in Hydrophobic Interaction Chromatography (HIC) Using Capto™ Resins
In this study, the hydrophobicities of newer-generation Capto™ HIC resins were compared to Sepharose™ High Performance and Sepharose Fast Flow HIC resins. An application example is also present…
Article
Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…
Article
Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges.
By Cynthia A. Challener
sdecoret/Stock.Adobe.com
Pr…
Article
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
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Article
Nurturing Knowledge from Disparate Data Streams
The same issues exist for biosimilar comparability studies, Rodríguez-Mendieta notes. “Results have to be considered holistically, which remains a considerable challenge, as the data can be somewhat c…