Digital Learning
Scientific Posters
EBF, 2024
Development of an Optimized Statistical Method And Full Validation of the Electrochemiluminescence Immunoassay For Detecting Anti-Aav Antibodies In Human Serum
EBF, 2024
Validation Of An In Vitro Cell-Based Assay For The Detection of Neutralizing Antibodies Against Adeno-Associated Virus 9 in Cynomolgus Monkey
Eurotox, 2024
Validating Multi-Ion Channel Inhibition Assays Following Best Practice Considerations
ACT, 2024
Retrospective Study of Survivability and Histopathology Findings in Cannulated Rodents
ACT, 2024
Validation of the Flow-cytometric Peripheral Blood Micronucleus Assay in Mouse
AAPS, 2024
The Application Of 19f-NMR In The Analysis Of Drug-Related Substances Of Leritrelvir (Ray1216) In Human Urine And Fecal Samples To Support A Phase I Clinical Study
AAPS, 2024
Lumbar Intrathecal Infusion of an siRNA Formulation via Cannulation in Rats
AAPS, 2024
Method Development And Validation Of A Cell-Based Assay For The Detection Of Anti-AAV Neutralizing Antibodies In Human Serum
AAPS, 2024
Overexpression of Human ApoC3 Leads to Hypertriglyceridemia and
Induces Key CVD-related Lipid Biomarkers
AAPS, 2024
Comparative Metabolite Profiling and Identification of a GalNAc-Conjugated siRNA_siRNA01
AAPS, 2024
Comparison Of The Performance Of Luminex-Based And MSD-Based Immunogenicity Assays For Multivalent HPV Vaccines
AAPS, 2024
Development of a Rapid, High Throughput Quantitative Bioanalysis Method for Conjugated Payloads of Protease-Cleavable Antibody-Drug Conjugate (ADC) in Rat Serum Using Automated Immuno-Capture Based UPLC-MS/MS
AAPS, 2024
Simultaneous Quantification Of Multiple ADC Component Concentrations And DAR Profiling With One Aliquot Of Plasma In NHP Toxicology Study By Hybrid LC-Ms
ISSX, 2024
A Rapid Liquid Chromatography-Tandem Mass Spectrometry Method for Quantifying the Metabolites of Seven Major Probe Substrates in Human Liver Microsomes
ISSX, 2024
A Sensitive and Efficient LC-MSMS Method for Creatinine-d5 Analysis in In Vitro OCT2 Inhibition Assay
ISSX, 2024
Assessment of In Vitro Methods for UGT1A1 Inhibition in Recombinant Isozyme
ISSX, 2024
Comparative Metabolite Profiling and Identification of a GalNAc-Conjugated siRNA siRNA01 in Plasma Prepared with Various Anticoagulants Serum and In Vivo Plasma
ISSX, 2024
Development of an In Vitro Platform for Screening UGT Inhibitors Using Human Liver Microsomes
ISSX, 2024
Does the Flux Competition Method Add Significant Value in Species Difference Protein Binding Evaluation
ISSX, 2024
Effects of Anesthesia and Different Lymphatic Fluid Collection Methods on the Lymphatic Transport of Orally Administered Drugs A Comparative Study in Rats
ISSX, 2024
Effects of Lipoprotein Binding and Plasma Dilution on the Accuracy of Ultracentrifugation Method in Plasma Protein Binding
ISSX, 2024
Evaluation of Cytochrome P450 Inhibition in the 7-in-1 Cocktail Using Preferred Substrates Recommended by Regulatory Agencies
ISSX, 2024
Evaluation of Different Tissue Processing Methods in Bama Pig Skin as an Animal Model for Topical Delivery Systems
ISSX, 2024
In Vitro Metabolic Stability Evaluation of ADCs in Plasma and Whole Blood
ISSX, 2024
Is the Dilution Method for Measuring IC50 Shift Values a More Sensitive Approach for Evaluating Time Dependent Inhibition
ISSX, 2024
Rapid Adenosine Bioanalysis with LS-LC-MS
ISSX, 2024
Rapid Determination of Lipophilicity Exploration and Establishment of Reversed-Phase Liquid Chromatography (RPLC) Methods
ISSX, 2024
A Comprehensive Platform for Evaluating the In Vitro CYP Reaction Phenotyping of New Molecular Entities (NME)
Eurotox, 2024
Method Development Optimization for Intravesical Instillation in the Rat
SOT, 2024
A Retrospective Analysis of Internal In Vitro Chromosomal Aberration Data
WRIB, 2024
LCMS-Based Strategies For In Vivo Dar Characterization In NHP Serum
WRIB, 2024
A Novel Whole Blood Cryopreservation Method For Flow Cytometry Based Leucocyte Immunophenotyping
WRIB, 2024
Novel DNA purification method facilitates the bioanalysis of DNA-based gene therapeutics in whole blood samples
SOT, 2024
Comparison of Changes of Hematology & Coagulation in Fasted & Non-fasted Non-Human Primates
SOT, 2024
Case Study: Re-consider Using Flow Cytometry for In Vivo Micronucleus Assay
SOT, 2024
Novel Approach to Mitigate Pharmacological Actions of a Novel Hedgehog (Hh) and Smoothened (Smo) Inhibitor to Successfully Complete a 26 Week Rat Study
SOT, 2024
Spontaneous Ocular Abnormalities in Sprague-Dawley Rats
SOT, 2024
Retrospective Review of Tolerable Levels for Polyethylene Glycol in Non-Clinical Studies as a Vehicle Component
SOT, 2024
Comparison of Systemic Exposure in Pregnant and Non-Pregnant Sprague-Dawley Rats
SOT, 2024
Method Development Optimization for Intravesical Instillation in the Rat
SOT, 2024
Consideration of Tongue Toxicity in Ocular Toxicity Studies
SOT, 2024
Establishment of Preclinical Immunotoxicity Reference Based on a Large-scale Immunophenotyping Data in Cynomolgus Monkey
White Papers
Developing a Convenient In Vitro Method for Predicting Metabolism and Disposition of Acrylamide Covalent Drugs in Humans
Detect and Characterize In Vitro PCCs of Non-Cleavable ADCs Using a New LC-HRMS Method
Unknowns are Unacceptable
Pharmacokinetic Bioanalysis Strategies for Antibody-Drug Conjugates (ADCs)
Based on LC-MS
The BAMA MINIPIG in Toxicology
Comparison Between Magnetic Bead and Membrane Immunoaffinity Purification Methods for the Measurement of Monoclonal Antibody in Rat Serum
Internal Standard (IS) Variation Case Studies: Emerging From Three Common IS Challenges
Metabolite Identification (MetID): A Critical Step in Drug Discovery and Development
ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation
The 2019 FDA Guidance’s Implications for Immunogenicity Assessment
Bridging Preclinical and Clinical Assays for Biologics Development –Challenges and Considerations for Phase I Trials
Webinars
Past Webinars
Optimizing DMPK Strategy for Peptide Drugs
Overcoming Challenges in Precise Structural Identification of Target Metabolites
Challenges and solutions in bioanalysis for oligonucleotide drugs
Discovery, Characterization, and Manufacture of Peptide Radiopharmaceuticals
Integrated bioanalytical strategy for LNP-mRNA products
Challenges and solutions in bioanalysis for oligonucleotide drugs
Facilitating ADC Preclinical DMPK Research with An Integrated Bioanalysis Platform
Facilitating ADC Preclinical DMPK Research with An Integrated Bioanalysis Platform
DPMK Strategies in the Preclinical Development of Antibody-Drug Conjugates
DMPK Strategies for Successful Clinical Translation
Hot Topics and Challenges in Drug Development
The Strategies and Methods of in-vitro ADME Characterizations of ADCs
ICP-MS
DMPK Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development
Designing Extractable/Leachable Studies for Drugs and Biologics
Expediting Biologics Drug Development: Strategies to Accelerate Preclinical Development Timelines
DMPK Optimization of Proteolysis-Targeting Chimeras
Preclinical Oligonucleotide Drug Development: Insight from DMPK
DMPK Strategies for Oligonucleotide Therapeutics
Brochures
IND, Enabled
Bioanalytical Services
Oligonucleotide Drugs
Proteolysis Targeting Chimera
Peptide
Antibody Drug Conjugate
Peptide-Drug Conjugate
Safety Assessment Services
Service Catalog
Drug Metabolism and Pharmacokinetics
Presentations
Check out our 15-minute presentation on the revolutionary impact of ADCs in targeted cancer therapy. Detailing their journey from conception to becoming a leading treatment modality, we highlight the significant bioanalytical challenges and regulatory milestones that shape ADC development.
What you will learn:
- The components of ADCs and their roles in targeting and killing tumor cells
- Bioanalytical details on PK, PD, immunogenicity, receptor occupancy and immunotoxicity studies
- Analytical platforms and techniques
- Challenges in ADC bioanalysis
- Guidelines and strategies for biomarker bioanalysis
Is your Drug Ready for an IND?
Maximizing Outcomes Through Multi-Site Study Collaboration
Development, Comparison of Quantitative Analytical Methods to Evaluate Plasma Antibody-Drug-Conjugates
Smart Strategies of ADME-PK for Large Molecules
In Vitro DDI Considerations for New Modalities
Integrated Bioanalysis and Biotransformation Strategies for Antibody-Drug Conjugates
Cost-effective In Vitro Methods for Evaluating the DDI Potential in Drug Discovery