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home.png Home>Blog>Litchlab Expands CDMO Services to Fluorescent Dyes & Molecular Probes: Enabling the Future of Optical Diagnostics and Theranostics

Litchlab Expands CDMO Services to Fluorescent Dyes & Molecular Probes: Enabling the Future of Optical Diagnostics and Theranostics

Litchlab, a Contract Development and Manufacturing Organization (CDMO) specialized in next-generation drug delivery and diagnostic platforms, has announced the official launch of its Fluorescent Dyes & Molecular Probes CDMO Service Line, providing end-to-end solutions spanning custom synthesis, scalable manufacturing, conjugation, and regulatory support.

As the life sciences industry shifts toward real-time visualization, molecular precision, and non-invasive monitoring, the global demand for robust, tunable, and biocompatible fluorescent systems continues to surge. From tumor-targeting NIR-II dyes to enzyme-activatable probes for inflammation, the applications of molecular probes are moving from bench to bedside.

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Comprehensive Platform Capabilities

🔹 1. Custom Fluorescent Probe Design & Development

  • Organic small-molecule dyes: FITC, Cy3/Cy5, Alexa Fluor™, Rhodamine, BODIPY, NIR-I/NIR-II fluorophores

  • Fluorescent nanoparticles: Quantum dots (CdSe/ZnS, InP), polymer dots, gold nanoclusters

  • Smart activatable probes: ROS-sensitive, pH-triggered, MMP-cleavable, glutathione-responsive

  • Multimodal probes: Fluorescence–MRI, Fluorescence–PET, Fluorescence–Photoacoustic (PAI)


🔹 2. Molecular Conjugation & Bioconjugate Engineering

  • High-efficiency coupling with:

    • Monoclonal antibodies, peptides, aptamers, nucleic acids

    • Liposomes, micelles, polymer nanoparticles, EVs

  • Site-specific labeling, controlled stoichiometry, linker optimization

  • Stability optimization in biological matrices (serum, plasma, interstitial fluid)


🔹 3. Scalable Process Development & GMP Manufacturing

  • Custom process chemistry optimization for dye synthesis and purification

  • GMP fill-finish for injectable, topical, or lyophilized probe formats

  • Sterile filtration, endotoxin control, moisture and light protection packaging

  • DLS, UV-Vis, fluorescence spectra, quantum yield, hydrodynamic diameter, and zeta potential profiling

  • Long-term and accelerated stability studies (ICH Q1A) under various storage conditions


🔹 4. Regulatory Documentation & IND/IMPD Support

  • Full CMC documentation and probe-specific safety dossiers

  • ICH-compliant impurity profiling and photostability analysis

  • Regulatory strategy support for:

    • Imaging agents (IND type V)

    • Optical diagnostics (510(k), IVDR)

    • Theranostic bioconjugates (IND type II or combination products)


International Trends Driving Fluorescent Probe Innovation

The global fluorescent probe market is expected to exceed USD 7 billion by 2030, fueled by:

✅ Rise of real-time intraoperative imaging systems (e.g., fluorescence-guided surgery)
✅ Increasing use of targeted fluorescent tracers in clinical trials (oncology, neurology)
✅ Growth of high-throughput cell imaging and multi-color pathology analysis in research
✅ Push for activatable and environment-responsive probes in inflammatory disease detection
✅ Regulatory acceleration for diagnostic–therapeutic conjugates (Dx/Rx hybrids)

📌 Key Application Areas

FieldExamples
OncologyTumor-targeted NIR-II dyes for surgical navigation, tumor–stroma probes
NeuroscienceBBB-penetrating probes for brain imaging, neuroinflammation sensors
Pathology & IVDMultiplex immunostaining reagents, chromogenic + fluorescent dual-use kits
TheranosticsFluorescent–drug conjugates for real-time therapeutic tracking
Screening PlatformsHigh-content screening dyes for phenotypic analysis, apoptosis/mitochondrial sensors

📧 Contact us today to explore collaborations in fluorescent molecule development:www.litchlab.com | ✉️ sales@litchlab.com