Search results for "cleaning"
Article
Process Chromatography: Continuous Optimization
Current protein A resins are also exposed to feeds with high concentrations of cell-culture nutrients yet are more sensitive to the high concentrations of sodium hydroxide needed for cleaning and sani…
Article
The New World of Biopharmaceutical Manufacturing
Advantages of single-use technology include greater flexibility, reduced resources for cleaning and cleaning validation, and faster turnaround between products and batches, resulting in reduced capita…
Article
Improving Process-Scale Chromatography
Most notably, significant reductions in the use of energy, water for injection (WFI), process water, clean steam, and cleaning chemicals are major drivers in favor of single-use technologies.
Pote…
Article
Defining Risk Assessment of Aseptic Processes
This is accomplished through proper building, equipment materials, and design; established and validated cleaning procedures; proper training for personnel; and continuous monitoring of the personnel …
Article
Selecting a Comprehensive Bioburden Reduction Plan
The identified risks and severity levels inform planning of raw material selection, facility design, process elements and conditions, cleaning and sanitization requirements, establishment of alert/act…
Article
Trends in Single-use Bioreactors
Especially in cell culture applications, vessel cleaning is very important to prevent the possibility of contamination. It’s not uncommon to have a standard operating procedure that calls for disassem…
Article
Best Practices in Adopting Single-Use Systems
The adoption of single-use systems in biopharmaceutical production originated with the desire to minimize cleaning and associated validation. Before long, bioprocessors recognized the value of flexibi…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
In addition, more cost-efficient cleaning procedures are necessary to extend the lifetime of chromatography resins and to reduce the cost for cleaning and validation. A team from Chugai Pharmaceutical…
Article
Alkaline stability of Fc and VH3 binding in protein A resins
In this study, we have looked at how different antibody binding sites of a protein A ligand are affected by cleaning in place (CIP). We evaluated NaOH incubation and the effect of performed CIP cycles…
Article
Maximum Output Starts with Optimized Upstream Processing
SU technologies are also being widely implemented for commercial as well as clinical production to minimize the time and costs associated with maintenance and cleaning of standard reusable equipment, …