Litchlab is a specialized CDMO dedicated to the development, optimization, and GMP-compliant manufacturing of advanced microsphere and nanoparticle-based drug delivery systems. Our integrated services help pharmaceutical partners overcome formulation challenges, enhance therapeutic performance, and accelerate clinical translation.
Microspheres and nanoparticles are at the forefront of controlled release and targeted drug delivery technology, offering versatile solutions for complex molecules and therapeutic indications:
| Delivery Carrier | Key Advantages | Suitable APIs | Therapeutic Applications |
|---|---|---|---|
| Microspheres (1–100 μm) | Sustained release, long-acting effect, localized delivery | Small molecules, peptides, proteins, vaccine antigens | Oncology, chronic diseases, injectable depot formulations |
| Nanoparticles (10–500 nm) | Targeting capability, improved bioavailability, enhanced stability | Nucleic acids (mRNA, siRNA, pDNA), small molecules, proteins | Gene therapy, cancer immunotherapy, vaccine delivery |
✅ Versatile Material Portfolio
PLGA microspheres (poly(lactic-co-glycolic acid))
PLA/PCL/PEG-based polymeric microspheres
Lipid nanoparticles (LNPs)
Polymeric nanoparticles
✅ Broad Payload Compatibility
Poorly soluble small molecules
Biologics: peptides, proteins
Nucleic acids: siRNA, mRNA, pDNA
Vaccine antigens and immunomodulators
✅ Robust Process Development
Solvent evaporation, spray-drying, lyophilization
Single emulsion (O/W) and double emulsion (W/O/W) microsphere techniques
Microfluidics-based nanoparticle manufacturing
Freeze-drying optimization for storage stability and global logistics
1️⃣ Formulation Development & Process Optimization
Tailored design of microsphere and nanoparticle systems to match target release profiles, encapsulation efficiency, particle size distribution, and API stability.
2️⃣ Scale-up & GMP Manufacturing
Seamless technology transfer from lab-scale (10 mL) to GMP clinical batch production (up to 100 L), ensuring scalability and reproducibility.
3️⃣ Analytical Development & Validation
Comprehensive characterization including:
Particle size and distribution (DLS/LS)
Drug loading and encapsulation efficiency (HPLC/UV)
Release kinetics profiling
Morphology analysis (SEM, TEM)
Degradation and stability testing under ICH guidelines
4️⃣ Lyophilization & Stability Enhancement
Screening of cryoprotectants, optimization of freeze-drying cycles, reconstitution validation, and accelerated stability studies to ensure long-term product integrity.
5️⃣ Regulatory Support & Documentation
GMP-grade production aligned with global regulatory expectations (FDA, EMA, NMPA) to support IND, NDA, and ANDA submissions.
✔️ Comprehensive CDMO services from formulation screening to GMP clinical production
✔️ Proven expertise in nucleic acid, protein, peptide, and small molecule encapsulation
✔️ Advanced freeze-drying capabilities for superior product stability and global distribution
✔️ Regulatory compliance across major markets (FDA, EMA, NMPA)
✔️ Accelerated timelines and full analytical support for efficient clinical translation
📧 Contact: RD2@litchlab.com
📩 Learn more or inquire about a project: www.litchlab.com
