qPCR assays for RCL monitoring are a rapid method to detect and usually quantify lentiviral genes, such as the envelope gene vesicular stomatitis virus G…
In-Cell ELISA Assays to Assess Drug Relative Potency Using the Cytation Imaging Reader for Sample Analysis
Potency assays are crucial characterization tools for almost all biotherapeutics during clinical and pre-clinical development for quality control and market authorization purposes.
The ability of enzymes to remain active outside their source organism makes them an ideal candidate for biotherapeutics.
Biomarkers associated with neurodegenerative diseases and traumatic brain injuries, including Nf-L (Neurofilament light) and GFAP (Glial fibrillary acidic protein) have been identified as potential prognostic…
Clinical trials requiring analysis of more than one biomarker can greatly benefit from implementation of multiplex biomarker panels.
Potency Assay Development for Gene Therapy Products – Approaches and Points to Consider in Data Processing
Gene therapies – including AAVs, engineered viruses and polymer formulated oligonucleotides/plasmids – are among the highest growth area in biopharmaceuticals.
To assess the toxicokinetics (TK) exposure of pirfenidone (AP01) during a 28-day oronasal dog inhalation toxicity study
Comparison of the Pharmacokinetics of Four Different Dose- Frequency Combinations of AMZ001 (Diclofenac Gel 3.06%) with Voltaren® (Diclofenac Gel 1%) in Healthy Subjects in a Phase 1 Study
To evaluate how the steady state levels of AMZ001 applied one or two times daily compare to Voltaren® applied four times daily in healthy subjects.
Efficient and Economical Preclinical Pharmacokinetic Analyses for Human Therapeutic Antibodies and Constructs, Using a Validated Human Immunoglobulin Immunoassay in Plasma of Mice, Rats, and Monkeys
This work was conducted to develop and validate (fit-for-purpose, FFP) an efficient means for pharmacokinetic (PK) analyses of large molecule drugs composed in part, or…
Pirfenidone and its Metabolites 5-Carboxy-Pirfenidone and 5-Hydroxy-Pirfenidone Toxicokinetics in Rats Following Inhalation of a Nebulized Aerosol Formulation
To assess the toxicokinetics (TK) of pirfenidone (AP01) and its main metabolites 5-carboxy-pirfenidone and 5-hydroxy-pirfenidone during a 26-week oronasal rat inhalation toxicity study.