As the global pharmaceutical industry accelerates toward advanced delivery technologies, liposomes have emerged as a cornerstone in modern drug delivery platforms, driven by the rising complexity of drug pipelines, regulatory scrutiny, and demand for targeted therapies. In response to this dynamic landscape, Litchlab has announced the full-scale upgrade of its Liposomal Drug Delivery CDMO Platform, providing integrated services from formulation development to GMP manufacturing and global regulatory support.
This initiative aims to solidify Litchlab’s position as a leading CDMO partner for small biotech and multinational pharmaceutical companies pursuing complex injectable, long-acting, and precision-targeted delivery solutions.
The global liposomal drug delivery market has surpassed $7 billion in 2024, with a projected CAGR exceeding 13%, according to Frost & Sullivan. Key growth drivers include:
Increasing adoption of liposomal formulations in oncology and infectious diseases
RNA therapeutics (mRNA, siRNA) requiring biocompatible, efficient encapsulation platforms
Emergence of long-acting injectables (LAI) and depot formulations
Regulatory agencies (FDA, EMA, NMPA) strengthening oversight of complex injectable CMC requirements
This environment necessitates CDMO partners with proven expertise in both formulation science and global regulatory navigation—a role Litchlab is increasingly recognized for.
Litchlab’s liposome CDMO services span the full development continuum, from early-stage feasibility to clinical supply and commercial readiness. Key platform strengths include:
Extensive library of liposomal structures: PEGylated, cationic, thermosensitive, stimuli-responsive, etc.
AI-assisted formulation design tools integrating molecular dynamics and compatibility modeling
Advanced analytical assays (AF4-DLS, HPLC-MS/MS, encapsulation efficiency, release kinetics)
QbD-driven process development with defined CPP-CQA modeling
Microfluidic and TFF-based manufacturing platforms for reproducible and scalable production
Intermediate scale-up units (10–100L) for technical transfer, process validation, and clinical bridging
Full method development and validation: particle size, zeta potential, EE%, residual solvent, free drug
ICH-compliant stability studies under various conditions (25°C/60%RH, 5°C, -20°C, accelerated)
Electronic Quality Management System (eQMS) and digital batch records for audit readiness
eCTD-compliant CMC dossier preparation (IND, IMPD, DMF) in both English and Chinese
Regulatory support for FDA, EMA, NMPA, PMDA submissions and response to deficiency letters
Global filing strategy advisory and CMC Q&A documentation packages
Dedicated liposomal GMP suites (under construction) supporting injectables, lyophilized formulations, and microspheres
Single-use technologies (SUT) and cleanroom integration for aseptic and scalable production
Global cold-chain logistics and controlled distribution for clinical and early commercial use
Litchlab is building next-generation capabilities by integrating its core liposome technology with advanced delivery and diagnostic systems:
Liposome + RNA Delivery: Hybrid platforms for dual-encapsulation and synergistic targeting in vaccines and immunotherapies
Liposome + Click Chemistry: Site-specific targeting ligands enabled via modular chemical conjugation
Liposome + Immune Modulators: Incorporation of TLR agonists to enhance immunogenicity in cancer and vaccine delivery
Liposome + Predictive AI Models: ML-driven prediction of lipid–drug compatibility and formulation stability
Litchlab delivers projects through an integrated global project management system, offering:
Dedicated technical PMs and regulatory consultants with cross-time-zone coverage
Weekly milestone meetings, risk tracking dashboards, and Gantt-based timeline visualization
Transparent communication, fast feedback cycles, and tailored deliverables for each client stage
With a rapidly evolving facility network, multi-regional filing experience, and expanding technological portfolio, Litchlab aims to become a world-class lipid nanoparticle and liposomal CDMO platform. By bridging early discovery with commercial launch, Litchlab empowers clients to accelerate innovation, ensure quality, and achieve regulatory success worldwide.
Whether you're developing an early-stage oncology candidate or preparing global registration for a complex injectable, Litchlab is your full-spectrum partner for liposomal innovation, efficiency, and compliance.
🔗 Learn more: www.litchlab.com
📧 Email: sales@litchlab.com
