Search results for "cleaning"
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
• Parameters for sterilization processes and cleaning process and the preparation of process intermediates can be included in the primary process assessment. Alternatively, they can be treated as inde…
Article
Trends in Downstream Bioprocessing
…ography materials
• Lack of single-use (disposable) options
• Cost of membranes
• Cleaning and validation costs
• Time for operations.
In addition, while many firms would like to …
Article
The use of Xcellerex™ mixing system as slurry tank when packing chromatography columns
The single-use system eliminates the hassle of time-consuming and costly steamin-place, clean-in-place, and cleaning validation procedures. The result is an efficient processing and rapid batch-to-ba…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
…urities such as DNA and some HCPs were captured on the resin (and later removed by regeneration and cleaning steps). After anion exchange, the flow-through fraction containing the antibody was passed…
Article
The Lifecycle Change of Process Validation and Analytical Testing
Read More About Process Validation in this PDA Tech Report for Biocleaning Cleaning Validation.
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.
ABSTRACT
The use of small-interf…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
The benefits of a two-column purification process include reduced capital, footprint, quality systems, validation, cleaning, development costs, solutions, and water consumption. The HTS method has als…