Medicilon Inc. integrates traditional antibody platforms with advanced NAMs technologies to build a human-relevant, prediction-driven R&D system, accelerating efficient and compliant antibody approvals.
📊 Track Record
• 42 Antibody INDs
• 100+ ADA projects
• 30+ PDXO models
• AAALAC accredited
⚡ Antibody Discovery: Hybridoma / Single B Cell + AI
Decades of hybridoma experience, single B cell screening (6‑8 weeks, natural VH/VL pairing), phage display libraries, plus AI‑driven epitope prediction, structural modelling for affinity maturation to early filter high immunogenicity risk sequences, and accelerate Hit‑to‑Lead.
🧪 In Vitro Pharmacology: From Binding to Functional Organoid Assays
Binding & functional assays:
📊 Binding/functional assays
FACS · ELISA · SPR · ADCC · CDC...
Validated targets: PD-1, PD-L1, HER2, EGFR, Nectin family, EPHA1-5, 4-1BB, FcRn, C1q …
🔬 PDXO organoid function
Colorectal, gastric, pancreatic, lung, prostate cancer;
H&E, WES/RNAseq, SOC validation.
🛡️ Safety Evaluation: From CRA to Omics Off-Target Analysis
NAM's applications include:
• Cytokine Release Assay (CRA) – multi-donor PBMC panels (8–10 cytokines) for immunomodulatory risk
• Platelet activation assays – thrombosis risk assessment (CD62P by FACS)
• Transcriptomics / proteomics – off-target profiling (dose-dependent specificity insights)
• 3D HepG2 models – improved hepatotoxicity correlation vs 2D systems
📈 In Vivo Pharmacology & PBPK Modeling
▶ CD3 bispecific antibody (NOG mice)
Tumor cells + hPBMC co inoculation, tumor inhibition TGI = 90.38% (p < 0.001)
▶ YYB‑101 (anti‑HGF, cynomolgus monkey)
Single IV PK: t½ ≈21.7 days, CL=0.11 mL/kg/h, Cmax 221.57 μg/mL
Repeated dose TK: accumulation ratio 2.38-2.95, exposure proportional to dose
🧠 PBPK modelling to predict human PK
Integrate in vitro ADME data (plasma protein binding, metabolic stability, LogP, solubility, etc.) with nonclinical PK to build species‑specific PBPK models, extrapolate human PK curves, and support FIH dose selection. Reduces animal use and improves translation success.
🔗 Integrated Platform: Traditional + NAMs: https://lnkd.in/enqgjUuX
✅ Full chain: Discovery → CMC → GLP → NAMs
✅ Regulatory ready: FDA / NMPA / OECD / TGA
✅ 42 Antibody IND track record
By combining established antibody expertise with human-relevant NAM technologies, Medicilon Inc. supports both current regulatory standards and future trends.
#AntibodyDevelopment #Biologics #NAMs #DrugDevelopment #TranslationalScience #PBPK #NonclinicalResearch
