Search results for " scale up" in Articles / App Notes
Article
Scaling a mAb Production Process to Xcellerex Bioreactors
This article discusses moving a monoclonal antibody (mAb) production process from a microscale bioreactor to the Xcellerex XDR single-use platform.
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Article
Being Thorough When Transferring Technology
By Susan Haigney
Editor's note: The following is an extended version of the article published in the print version of BioPharm International's March 2017 issue:
Tech transfer and scale up of b…
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Scaling strategies in STRs are well established though, and single-use options exist from the millilitre scale up to 6000 L (7).
Recent technological innovations provide substitute solutions. The …
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
“At Pall, we are increasingly seeing customers reaching out for help with process scale up using our scalable manufacturing platform,” Cameau comments. The company’s Accelerator Process Development Se…
Article
Mapping a Route for Cell and Gene Therapy Process Development
…ility of the cells) within the bioreactor is necessary to gather the data needed to enable effective scale up of upstream processes, Lamproye adds. In many cases, he notes that the need to develop, v…
Article
Tools for Continuous Bioprocessing Development
As a result, biopharmaceutical process development and scale up are rarely linear. Fundamental understanding of the cellular and biochemical processes involved is often sacrificed because it isn’t alw…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
“Balancing human ingenuity and adaptability against reducing opportunities for human error is a natural outcome of the scale up process, so opportunities for contamination are very limited at the manu…
Article
Using Digital Twins to Model Process Chromatography
BioPharm International spoke with Whitelock about how digital twins are used in biopharmaceutical process development, scale up, tech transfer, and manufacturing, particularly chromatographic polishin…
Article
Platform Approach Speeds Process Development
…velopment to identify optimal process parameters for highly productive processes, and strategies for scale up to clinical and commercial scales.
Depending on the development goals, different develo…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…