Search results for " serum"
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
To study the effects of glycan structure on the clearance of an Fc receptor fusion protein, an affinity extraction method was developed that could specifically recover the drug from cynomolgus monkey …
Article
Milestones and Moderate Progress in 2012 Drug Approvals
The sugar chains are devoid of sialic acid caps, which can negatively influence their serum half-life.
Elelyso is a recombinant human glucocerebrosidase used as a replacement therapy to treat Ga…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…