Scientific Posters
Points to Consider in the Development of Activity and Potency Assays for Enzyme Biotherapeutics
The ability of enzymes to remain active outside their source organism makes them an ideal candidate for biotherapeutics.
Qualification of a Neurology 2-Plex B (Nf-L, GFAP) Quanterix Simoa® Assay Using a Novel Approach
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…
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.
Toxicokinetics of Pirfenidone in Dogs Following Inhalation in a Nebulized Aerosol Formulation
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.
Design Of Total Anti-Vegf Assay Provides Simple Data Interpretation Of Anti-Vegf Therapeutic Study
Vascular Endothelial Growth Factor (VEGF) is an angiogenic factor associated with an array of diseases, including several cancers and retinopathy, making this protein both a…
Determination of Mifepristone in Human Plasma by Automated On-Line SPE Combined with MS/MS
Mifepristone is a synthetic steroid compound that has been studied in Phase II clinical trials for many medical uses, including: oral contraception, uterine fibroids, endometriosis
Embryo-Fetal Developmental Toxicokinetic Study of CBX129801, a Bio-active C-peptide for Potential Replacement Therapy in Type 1 Diabetic Nephropathy, in Rats and Rabbits After Subcutaneous Injections
To evaluate the maternal toxicokinetics and fetal exposures of CBX129801 in studies which assessed the developmental toxicity, after subcutaneous injection for 4 doses to pregnant…