We're delighted to be attending Preclinical Development and IND Filing for Antibody Therapeutics, hosted by PBSS (Pharmaceutical and Bioscience Society International) in Seattle, Washington on October 14, 2025.
If you’re attending, stop by our tabletop during the event or book a meeting in advance. We’d love to meet you and explore how we can help you navigate preclinical and clinical requirements for your biotherapeutic.
The meeting brings together the science community and pharmaceutical leaders around the topic of successful IND (Investigational New Drug) filings for antibody-based drugs and therapies.
The event will cover:
- Overview of preclinical development and IND filing requirements for antibody-based therapeutics
- Required preclinical studies for
- Safety assessment
- Pharmacology
- Pharmacokinetics
- CMC (Chemistry, Manufacturing, Control)
- Clinical development plans
- Regulatory strategies and agency interactions
- FDA’s perspective
Custom Biologics is a regulatory compliant large molecule CRO providing advanced bioanalytical and potency testing solutions for antibodies as well as other biotherapeutics.
We can support you with:
- Characterization of AAV, lentivirus, and oncolytic viruses
- Potency assays that reflect mechanism of action (MOA) and infectivity
- Vector identity, purity, titer, and stability testing
- Phase-appropriate method development, qualification & validation
- Smooth tech transfer from preclinical to commercial manufacturing
Specific assay platforms we can provide:
- ddPCR / qPCR / RT-qPCR – Vector genome titer, biodistribution, and shedding
- Bio-Layer Interferometry (BLI) – Binding kinetics & vector–ligand interactions
- ELISA / MSD-ECLIA – Capsid, transgene product, and host cell protein quantitation
- ELISpot – Immune response assessment
- SDS-PAGE / Western Blot – Purity, identity, and protein characterization
Schedule a meeting with our team. We hope to see you there!
Where: Seattle, WA
When: October 14, 2025
Registration & Agenda: Full Program
