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Services

Therapeutic Modalities

Nucleic Acid Therapeutics

(mRNA | ASO | siRNA | RNA-editing)

  • LC–MS/MS | Hybridization-LBA | q/dPCR & RT-qPCR | NGS
  • Cytokine, complement, and anti-ASO and anti-PEG immunogenicity assessment
  • BioMarkers

(Monoclonal & Bispecific Antibodies | Fusion Proteins)

  • PK (total/free), soluble targets, ADA/NAb, RO/TE, potency assays
  • ADCC/ADCP/CDC, and MoA-aligned functional studies
  • BioMarkers
  • Total antibody (LBA), conjugated ADC (Hybrid LBA–LC–MS), free payload (LC–MS/MS)
  • ADA responses to the conjugated ADC, unconjugated antibody, and linker–payload
  • BioMarkers
  • Humoral & cellular immunity assays (MSD, ELISA, PRNT, ELISpot, Flow)
  • WHO-standardized immunobridging
  • BioMarkers
  • Immunoassay & molecular
  • Analytical & clinical validation per CLSI and ISO 13485/15189 standards
  • BioMarkers
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Development Phase

Discovery → IND-Enabling → FIH → Phase 2 → Phase 3 / Registration

  • Discovery / IND-Enabling: Fit-for-purpose assay design, MoA/PD strategy, ICH M10 bioanalytical plan
  • First-in-Human (FIH): PK, ADA/NAb validation, RT-qPCR PD
  • Phase 2: Exposure–response modeling, expanded PD/biomarker suite, comparability
  • Phase 3 / Registration: Lifecycle validation updates, lot-to-lot consistency, BLA/MAA modules, inspection readiness
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Technical Platforms & Quality Systems

  • Analytical Platforms

MSD | ELISA | Gyrolab | Simoa | LC–MS/MS | q/dPCR | RT-qPCR | NGS | Flow Cytometry | Cell-Based Assays

  • Quality & Compliance Framework:

ICH M10 | ICH Q2(R2) | FDA/EMA BMV | ALCOA+ | 21 CFR Part 11 | ISO 13485 / 15189 | WHO / NIBSC / USP / Ph. Eur.

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