Search results for " system" in Articles / App Notes
Article
USP Publishes Monoclonal Antibody Guidelines
While this standard is not to be used for identification or to assign content, it has been developed to establish IgG system suitability. The material is an IgG1, 2mg/vial lyophilized presentation, wh…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Additionally, as Brown points out, LO “can only measure particle size via an indirect measurement of volume converted to size based on assumption of spherical shape,” so imaging systems must also be u…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Recent years have seen much greater adoption of single-use chromatography, including both systems with separate consumables and pre-packed columns. Interestingly, our customers normally purchase a sin…
Article
Continued Process Verification for Biopharma Manufacturing
Some elements of CPV overlap with existing GMP systems such as the generation of data for batch release (BR) decisions, annual product review (APR), and change control.
In general, the nature and …
Article
FDA Urged to Preserve Biosimilar Naming Conventions
“The organizations who know the most about healthcare delivery agree: departing from the currently accepted INN system will not benefit patients,” said Neas. “Instead, it will upset the very systems n…
Article
Trends in BioPharma Approvals in 2013
In terms of expression systems used, a total of eight of the products approved are expressed in mammalian cell lines (seven in CHO cells, one in Sp20), six are produced in yeast-based systems, four in…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Trend one: Outsourcing is growing across all production systems
Before looking at the finer details of the outsourcing landscape, it’s worth taking a broader view and data from BioPlan’s studies c…
Article
Biotechnology Innovation and Growth in Israel
The infrastructure of Israel’s healthcare system has come under scrutiny in recent years as the Israeli government continues to rein in its healthcare expenditures. Even though Israel’s economy has re…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical manufacturers’ change-control systems are designed to ensure that any changes to raw materials, product contact materials, manufacturing methods, product tests, and production equipment…
Article
Choose your Optimal Wavelength for Chromatography
With a variety of platforms available, from the easy-to-use ӒKTA start™, to the compact ӒKTA go™, flexible ÄKTA pure™ and security of ӒKTA avant™ through to the bioprocess-scale systems – the …