Dr. Sharon Williams, Product and Downstream Process Development Manager, ProMetic BioSciences Ltd Escherichia coli is a Gram-negative bacteria that is a popular host organism for the expression of recombinant protein biotherapeutics. Lysis of the outer membrane of Gram-negative bacteria, a requirement to release internalized target biomolecules, also releases substantial quantities of lipopolysaccharides (LPS), also known as endotoxin, into the process solution.
By Christine Park, Quality Architech
Document control is always an interesting topic for discussion. It seems like a simple topic and area for compliance, but I often run into companies with document control systems that are overly complicated and difficult to manage.
By Kathryn Martin Remington, Ph.D., Principal Scientist for Clearance Services, BioReliance
A viral clearance study is designed to experimentally demonstrate the virus reduction that could be achieved by selected steps in a biopharmaceutical manufacturing process in the unlikely event that process intermediates were to be contaminated by an infectious virus.
By Ed Miseta, Editor, Outsourced Pharma
Ask anyone involved with antibody drug conjugates (ADCs), and they will tell you this is an exciting time to be in the market. While there are some concerns about possible regulatory guidance that will eventually be crafted to address this relatively new market, two recent FDA approvals (Adcetris and Kadcyla), and several more products in clinical trials, has the future looking bright. Partnerships, such as the ones between Seattle Genetics and Spirogen, Celgene and Sutro Biopharma, and the acquisition of MedImmune by AstraZeneca, have been instrumental in advancing ADCs, and will continue to drive the technology going forward.