Device built-in

Solentim Monoclonal Cell Imaging Analyzer – Technical Overview

Solentim, a global leader in monoclonal cell analysis technologies, offers the Cell Metric™ Series and VIPS® System, providing fully automated, high-precision monoclonal verification solutions for biopharmaceuticals, gene therapy, and cell therapy, compliant with FDA/EMA regulatory requirements.

Core Technical Features

1. High-Resolution Imaging & Monoclonal Verification

   • 2μm/pixel resolution supports whole-well scanning (6- to 384-well plates), with AI-powered image analysis to automatically identify single cells, clusters, and impurities (>98% accuracy).
   • Continuous tracking from Day 0, generating growth curves and clonality evidence reports compliant with ICH Q5D and WHO requirements for monoclonal proof.

2. Automation & Efficiency

   • Full-plate scan in <3 minutes; the Cell Metric CLD with temperature control processes 10 plates simultaneously without manual intervention.
   • Integrated with the VIPS® Single-Cell Dispenser, achieving 2.7x higher efficiency than limiting dilution, with **>50% single-cell recovery rate**.

3. Regulatory Compliance

   • "Dual-Proof" reports (images + data) serve as direct IND submission materials, FDA-recognized to eliminate subcloning steps, shortening development timelines by **≥1 month**.

Key Applications

• Antibody Development: CHO cell line clonality verification (DAR value CV<2%).
• Gene Therapy: AAV empty/full capsid ratio validation.
• Cell Therapy: CAR-T monoclonal screening to avoid heterogeneity.

Competitive Advantages

Solentim’s Cell Metric + VIPS + ICON ecosystem delivers a closed-loop workflow from single-cell isolation → imaging → productivity analysis, accelerating cell line development.

Fields of Use: Pharma (mAbs/ADCs), CROs, academia.
Options: STUDIUS™ data management platform, InstiGRO™ culture supplements.

References:

1. Regulatory Guidelines for Monoclonal Imaging (2022)
2. Cell Metric Technical Manual (Solentim, 2024)
3. Cell Metric CLD Case Studies (2024)
4. VIPS PRO Dispensing Efficiency Study (2025)

(Note: "Cell Metric," "VIPS," and "InstiGRO" are registered trademarks of Solentim. Compliance with 21 CFR Part 11 and EU Annex 11.)

Key Terms:

• Monoclonal proof: Imaging evidence of single-cell origin.
• DAR (Drug-to-Antibody Ratio): Critical quality attribute for ADCs.
• Closed-loop workflow: End-to-end traceability from cloning to production.

(Translated with technical precision, maintaining brand nomenclature and regulatory alignment.)