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This fall, we’ll be joining leading scientists and regulatory experts in Foster City, CA, for Gene Therapy Challenges and Best Practices: From Discovery to IND and Beyond, hosted jointly by PBSS (Pharmaceutical & Bioscience Society International) and RAPS-SF (Regulatory Affairs Professionals Society, San Francisco chapter).
The full-day workshop will explore AAV gene therapy, RNA therapeutics, preclinical and clinical development strategies, bioanalytical method development, CMC considerations, and regulatory pathways.
We’re excited to connect with fellow innovators to share how Custom Biologics supports the development of gene therapy products with cell-based bioassays, ddPCR, ELISA, flow cytometry, and ligand-binding assays, and discuss solutions for assay development, QC lot release, and regulatory-compliant testing.
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 bring your gene therapy programs from discovery to clinic efficiently and confidently.
Excellence in Functional Characterization & Clinical Testing of Biotherapeutics and Gene Therapy Products
Custom Biologics is a regulatory compliant large molecule CRO providing advanced bioanalytical and potency testing solutions for gene therapy products 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: Foster City (San Francisco Bay Area), CA
When: September 26, 2025
Registration & Agenda: Full Program
