Posters
Validation of a Flow Cytometric Assay to Detect Antibodies to a Novel Cell Therapy for Immunogenicity Assessment
To assess the toxicokinetics (TK) of CBX129801 in Sprague Dawley
Rats following once weekly subcutaneous injection for 26 doses.
Toxicokinetics of CBX129801, a Bio active C peptide for Potential Replacement Therapy in Type 1 Diabetic PeripheralNeuropathy, Following Subcutaneous Injection of CBX129801 in Rats in a 6-Month Study with a 7-Week Recovery Period
To assess the toxicokinetics (TK) of CBX129801 in Sprague Dawley
Rats following once weekly subcutaneous injection for 26 doses.
Proof-of-Concept of a Qualitative qPCR Assay for RCL Monitoring
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.
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…