Litchlab, a leading CDMO innovator in nanoparticle-based drug delivery, has announced a significant enhancement of its PEGylated liposome (PEG-liposome) platform. This next-generation system focuses on long-circulating delivery, enhanced pharmacokinetics, anti-ABC effect strategies, and regulatory-grade manufacturing. The platform aims to accelerate clinical and commercial translation of long-acting nanomedicines in oncology, RNA therapeutics, CNS delivery, and chronic disease management worldwide.
Polyethylene glycol (PEG) modification remains a gold-standard strategy for improving nanoparticle stealth, increasing systemic circulation time, and enhancing tumor accumulation via the enhanced permeability and retention (EPR) effect. PEG forms a steric shield on the liposome surface, minimizing clearance by the mononuclear phagocyte system (MPS) and supporting prolonged drug exposure.
However, several technical challenges remain in the clinical development of PEGylated liposomes:
ABC Effect (Accelerated Blood Clearance): Repeated dosing may trigger anti-PEG immune responses, reducing efficacy.
Cell Uptake Barrier: Dense PEG layers may hinder endocytosis at the target site.
Formulation Complexity: Compatibility with diverse drug molecules (small molecules, peptides, RNA, etc.) is non-trivial.
Litchlab’s upgraded PEG-liposome platform addresses these limitations with modular design, adaptive formulation strategies, and GMP-scale translation capabilities.
Litchlab’s proprietary platform supports end-to-end drug development, from early formulation to clinical manufacturing. Key features include:
Supports single/double anchor PEG-lipids, cleavable PEG, and pH-responsive detachment.
Tunable PEG lengths (2k, 5k, 10k Da) and surface densities to balance stealth and uptake.
Integrates zwitterionic or biodegradable PEG analogs to mitigate ABC effect.
Particle size control (60–120 nm) via microfluidic mixing or membrane extrusion.
Robust stability under temperature, agitation, and freeze-thaw stress.
Long-term storage optimization, including lyophilization and cryopreservation.
Supports small molecules (e.g., doxorubicin, paclitaxel), peptides, proteins, and mRNA/siRNA.
Enables co-delivery platforms for dual-drug synergy and theranostic combinations.
IND/Phase I-III GMP production aligned with FDA/EMA/QbD expectations.
Full analytical support for PEG content, release kinetics, residual solvents, etc.
Integrated regulatory services across CMC, stability studies, and batch release.
According to industry reports (Grand View Research, Frost & Sullivan), the global PEGylated liposome market is projected to surpass $11 billion by 2030, with a CAGR over 10%. Demand is being driven by:
RNA therapeutics (e.g., mRNA vaccines, siRNA)
Antitumor agents requiring longer exposure with reduced toxicity
Targeted CNS drugs leveraging PEG’s ability to enhance BBB traversal
Dual-drug and multi-functional systems for immuno-oncology and combination therapy
Litchlab’s platform is ideally suited for these applications, combining pharmacokinetic modulation with smart release and functional targeting.
| Application Area | Model Drug | Target Tissue | Project Stage |
|---|---|---|---|
| Metastatic breast cancer | PEG-liposome Doxorubicin | Solid tumors | Phase I |
| mRNA vaccine platform | PEG-LNP mRNA | Liver, Lymph Nodes | Preclinical |
| Anti-fibrotic therapy | PEGylated GalNAc liposomes | Hepatocytes | Discovery stage |
| CNS drug delivery | PEG-liposome CNS drug | Brain | In vivo validation |
Litchlab delivers a one-stop development pipeline for PEG-liposome systems, ensuring seamless transition from R&D to GMP production:
Formulation Design: PEG-lipid screening, particle size tuning, release kinetics optimization
Process Development: Microfluidics, extrusion, TFF purification, lyophilization
Sterile Drug Product: Liquid injection, lyophilized vials, and sterile fill-finish
CMC & Regulatory Support: QbD documentation, analytical methods, shelf-life testing
Litchlab is a global CDMO specializing in advanced drug delivery technologies, offering comprehensive support for liposomes, LNPs, PEGylated systems, hydrogels, polymeric nanoparticles, and microspheres. Its platforms power innovation across therapeutic areas including mRNA, ADCs, peptides, small molecules, and biologics. Through design-led, GMP-enabled services, Litchlab empowers next-generation medicines from concept to commercialization.
