As precision medicine continues to evolve, the demand for advanced lipid-based drug delivery systems has surged—particularly for therapies involving siRNA, mRNA, antibody-drug conjugates, radiopharmaceuticals, and targeted chemotherapeutics. In response to this global need, Litchlab announces the launch of its fully integrated CDMO (Contract Development and Manufacturing Organization) service platform, focused on the development and GMP manufacturing of next-generation liposomal and nanocarrier drug products.
From discovery-stage startups to established pharmaceutical leaders, Litchlab empowers partners to rapidly translate complex therapeutics into clinically viable products—supporting everything from design and preclinical development to IND filing and GMP production.
Litchlab’s CDMO infrastructure is built on a vertically integrated system that combines:
Advanced liposome and LNP engineering platforms
In-house process optimization and scale-up capabilities
ICH-compliant regulatory and quality systems
Clinical and commercial GMP manufacturing suites
This “Lab-to-Clinic” model ensures full continuity of knowledge, reduced tech transfer risks, and faster time-to-market for complex therapeutics.
Targeted Ligand Engineering: Antibody fragments, peptides (RGD, HER2, PD-L1, ASGPR), aptamers
Microenvironment Responsiveness: pH-triggered, GSH-sensitive, enzyme-cleavable systems
Payload Versatility: Supports small molecules, mRNA/siRNA, CRISPR, monoclonals, radiolabels
Platform techniques: Thin-film hydration, reverse-phase evaporation (REV), microfluidics
High reproducibility: EE >85%, particle size 80–150 nm, PDI < 0.2
Stability studies: Accelerated, long-term, and forced degradation under ICH guidelines
CMC documentation (modules 2.3 & 3.2) in alignment with FDA, EMA, NMPA
Analytical method development & validation (HPLC, DLS, TEM, endotoxin, sterility)
IND-enabling studies support, including comparability protocols & quality risk assessments
Modular GMP suites for lipid nanoparticles, PEGylated liposomes, and hybrid systems
Batch size flexibility: from milligram-scale prototypes to multi-liter clinical lots
End-to-end tech transfer & process validation for late-stage partners
| Therapeutic Area | Payload Type | Target Ligand / Biomarker | CDMO Solution |
|---|---|---|---|
| Breast/Ovarian Cancer | Doxorubicin, Paclitaxel | HER2, EGFR | Ligand-targeted PEGylated Liposomes |
| Liver / Pancreatic Cancer | Radiopharmaceuticals | αvβ3, PD-L1 | RGD-Liposomes for deep penetration |
| Cardiometabolic Disease | siRNA (e.g., PCSK9) | ASGPR | GalNAc / Liposomal RNAi Formulation |
| Respiratory / Mucosal | mRNA + Adjuvants | TLR, ICAM-1 | Aerosolized LNP Vaccines |
| Rare Genetic Disorders | CRISPR/mRNA | Tissue-selective ligands | LNP with conditional release triggers |
Litchlab’s CDMO services are fully compliant with global regulatory expectations, enabling seamless progression from R&D to market access:
ICH Q8, Q11, Q12 implementation across development life cycle
ISO 9001 & GMP-certified facilities for sterile and non-sterile lipid-based drug products
Full project documentation & data traceability (LIMS, eBMR/eDMS systems)
Dedicated client portal for real-time communication and milestone tracking
Litchlab supports a wide spectrum of clients:
| Client Type | Typical Use Cases |
|---|---|
| Biotech startups | Liposome/LNP formulation + IND support |
| Mid-to-large pharma | Scale-up & GMP manufacturing of drug candidates |
| Academic & research orgs | Translational research + proof-of-concept support |
| Global CDMOs | Local tech transfer + regulatory alignment in Asia |
Litchlab provides collaborative flexibility—from co-development models to fee-for-service contracts, with full IP protection and confidentiality.
As the complexity of modern therapeutics increases, so too does the need for integrated CDMO partners with deep formulation expertise and regulatory foresight. Litchlab is proud to serve as that strategic partner—accelerating innovation and manufacturing with precision, compliance, and scalability.
📩 Learn more about Litchlab CDMO solutions: www.litchlab.com
📧 Contact: RD1@litchlab.com
