Search results for "validation"
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Viral Clearance: 7 Chromatography Column Considerations
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging.
Here are seven things to conside…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
By Feliza Mirasol
ARTMOIS/STOCK.ADOBE.COM
Biopharmaceutical manufactu…
Article
Fundamentals of Viral Clearance Studies with a Focus on Chromatography
These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatog…
Article
New HiScale™ 10/40 for Scale-Down Studies
Cytiva is pleased to announced the new HiScale™ 10/40.
HiScale 10/40 column is especially suitable for scale-down studies used in, for example, viral clearance evaluation in downstream processing. …
Article
Automating the Biomanufacturing Process
“RTR entails higher up-front cost for the equipment and start-up/validation, but allows batches to be released much faster with less human intervention,” Lebl says.
The need for integration betwee…
Article
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
…
Article
Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
By Cynthia A. Challener
…
Article
Achieving Process Balance with Perfusion Bioreactors
“Users can eliminate most of the cleaning and validation steps that are associated with stainless-steel systems, saving both time and cost. They can also realize economic benefits with the reduction o…
Article
A Plastic Pipeline for Commercial Bioprocessing?
…onfigurations, faster changeover times, the reduction or elimination of cleaning steps and cleaning validation, and a lower risk of cross contamination are recognized as benefits of single-use system…