Search results for " process"
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Increasing upstream titers can make the Protein A chromatography process step the rate-limiting step in downstream purification. Protein A chromatography columns are frequently too large, limiting the…
Article
Best Practices for Data Integrity
A thought process, for example, may be ‘Now we have production yield and quality data that are reliably collected, and we can trust their integrity. How might we leverage that data to minimize variabi…
Article
Biosimilars to Drive Modern Manufacturing Approaches
These efforts will be supported by a new agreement on policies for renewing the Biosimilar User Fee Act (BsUFA II), with provisions to streamline the biosimilar development and approval process (1). T…
Poster
Improve operational efficiency in biomanufacturing with comprehensive automation solutions
However, equipment used are often connected only by process; that is, the bioprocess material passing between each of them. Often this connection is discontinuous, meaning equipment is controlled on a…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Similar cell-culture media may be used simultaneously in one or few biological processes at a drug product manufacturing facility. As per Code of Federal Regulations (CFR) 211. 84, each media needs to…
Article
Optimization of Protein Expression in Escherichia Coli
Depending on the purpose of protein expression, these tags may be left in the final product or cleaved off with the use of specific proteases during the purification process.
Proteases such as Tev …
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
They are designed to improve downstream processing performance, ensure consistency of product, reduce cost, and reduce time between batch runs. Total suite, labor, and material costs decrease dramatic…
Article
Q&A with Industry Leaders: Rita Peters
One example is Cytiva’s acquisition of the HyClone line cell culture media, sera, and process liquids; Dharmacon RNAi gene modulation, products; and Sera-Mag magnetic beads. With the changes in compan…
Article
Predicting Progress in Protein Aggregation
As the development of biologic drugs based on antibodies and other protein/peptide molecules continues apace, the control and prevention of aggregation during manufacturing, downstream processing, for…
Article
Advancing QbD in the EU
In 2003, EMA set up a team to back activities in process analytical technology (PAT) in the EU. The agency has seen its PAT team as a key element in the implementation of QbD by encouraging process un…