Search results for " pharmacokinetics"
Article
Elucidating Biosimilars Characterization
These proteins would, therefore, require sample collection for many weeks to accurately define the pharmacokinetics and a washout period of some months between treatments with the originator product a…
Article
The Importance of Partnering for Bioanalytical Studies
…bioequivalence (BE) evaluation, and some nonclinical studies requiring concentration information for pharmacokinetics, toxicokinetics, or biomarkers. Bioanalytical work serves to supplement pivotal s…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Due to its bioprocess-associated variability and impact on safety, pharmacokinetics, and pharmacodynamics, glycosylation is widely regarded as a critical quality attribute (CQA) of TGPs (1).
In th…
Article
Antibody Production in Microbial Hosts
Yeast cells tend to hyperglycosylate the recombinant proteins (even at non-native positions), and this may result in altered pharmacokinetics, activation of complement system, and generation of anti-g…
Article
Reimagining Affordable Biosimilars
Exponential advances in new technologies and computing such as mathematical modeling of pharmacokinetics (PK) and pharmacodynamics (PD), organ-on-a-chip platforms, in-silico algorithms, and transgenic…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
On a therapeutic protein, the composition of these glycans can significantly impact the drug’s stability, pharmacokinetics, and biological activity. Thus, glycan structure is a critical quality attrib…
Article
Preclinical Evaluation of Product Related Impurities and Variants
This is followed by routine analysis using an array of tests (In vitro binding assays, in vitro potency assessment, pharmacokinetics, pharmacodynamics, toxicity assessment). The data from these studie…
Article
Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
Article
Emerging Therapies Test Existing Bioanalytical Methods
qPCR is used to quantify a viral genome in serum, tissue, or body fluids for the purpose of pharmacokinetics (PK), biodistribution, or vector shedding evaluations (3,4,6). It is also used to measure t…