Search results for " pharmacokinetics"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…lycan analysis using fluorescent labels, which can be used to detect the effects of glycosylation on pharmacokinetics and immunogenicity. In some cases, new approaches to sample preparation have redu…
Article
ADC Development Robust Despite Lackluster Performance
… 15--a three to four-fold increase in DAR compared to traditional ADC constructs--and still maintain pharmacokinetics and drug-like properties within an acceptable range, as demonstrated in animal mo…
Article
N-Glycan Analysis of Biotherapeutic Proteins
…f glycosylation in biotherapeutics, particularly on mAbs, in which the N-glycan structure can affect pharmacokinetics, pharmacodynamics, and immunogenicity (5). The impact of glycosylation on protein…
Article
Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
Article
Establishing Acceptance Criteria for Analytical Methods
Generally, to control the quality of a product and to manage drug safety and efficacy, there are two key elements: cinical trials evaluting the pharmacokinetics (PK) response to drug product and dose …
Article
Biosimilars: Making the Switch Comes with Challenges
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
By Sean Milmo
The use o…
Article
Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
By Cynthia A. Challener
Biopharmaceutical manufacturing involves a series o…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
…al characteristics of the biosimilar, it is necessary to demonstrate that the pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of the biosimilar are also comparable to those of the br…