Lipoplexes (LPLX) are self-assembling nanosystems for non-viral nucleic acid delivery, enabling scalable manufacturing. Viral vectors have safety/immunogenicity issues, while non-viral systems like Lipopolyplex (LPP) overcome biological barriers for diseases like Parkinson's.
Our Custom Lipoplex Development Services solve viral vector flaws (long cycles, poor delivery, BBB crossing) via advanced formulation, boosting nucleic acid delivery quality. We address naked nucleic acid instability, providing optimized formulations to speed up bench-to-preclinical translation.
Discover How We Can Help - Request a ConsultationThe fundamental mechanism of Lipoplex formation is the electrostatic interaction between the cationic (positively charged) head groups of the lipids and the polyanionic (negatively charged) nucleic acid phosphate backbone. This spontaneous self-assembly creates nanoparticles that protect the payload and facilitate cell membrane interaction. Critically, we employ helper lipids (e.g., DOPE), which are vital for destabilizing the endosomal membrane following cellular uptake (endocytosis), enabling the payload to escape into the cytosol, where it can express its therapeutic protein.
Fig.1 Evaluation of protein expression by in vitro and in vivo transfections with mRNA lipoplexes prepared by simply mixing of mRNA solution with a lipid-ethanol solution.1
Select optimal cationic lipids (e.g., DOTAP derivatives) and helper lipids (e.g., DOPE) based on the payload's size and charge density, laying the foundation for effective delivery.
Conduct high-throughput screening to determine the optimal N/P (Nitrogen-to-Phosphate) ratio, and adjust particle characteristics (size, PDI, Zeta potential) for best performance.
Evaluate serum stability, nuclease protection efficiency, and in vitro cytotoxicity profiles to ensure the formulation meets clinical safety standards.
Use pH-sensitive assays and targeted cell-line models to validate the lipoplex system's ability to release its payload into the cytoplasm, confirming functional delivery.
The typical timeframe for this service ranges from 6 to 12 weeks, depending heavily on the complexity of the target tissue and the scope of the in vivo efficacy studies requested.
Custom Lipoplex Design for Targeted Delivery
Tailor cationic lipid selection (e.g., DOTAP, custom-synthesized lipids) and N:P ratio based on payload type (mRNA, siRNA) and target cells; fine-tune helper lipids (e.g., DOPE) to boost endosomal escape.
One-Stop Process Development (Lab to Pilot)
Cover lab-scale (mg–g) formulation, pilot-scale (10–100g) optimization, and large-scale transfer support; optimize preparation techniques for consistent size (50–200nm) and low PDI (<0.2).
Strict Quality Control & Regulatory Compliance
Use QbD and PAT to monitor real-time CQAs (particle size, encapsulation efficiency >90%); follow GMP/HACCP, with docs (batch records, purity reports) compliant with FDA/EMA IND/CTA.
Cytotoxicity Minimization & Safety Enhancement
Screen low-toxicity cationic lipids and optimize composition for higher safe doses; conduct in vitro (MTT assay) and in vivo toxicity studies to ensure biocompatibility.
Scalable Production with Flexible Capacity
Leverage scalable equipment (microfluidic systems, large mixers) for up to kg-level production; standardize raw materials and procedures to reduce batch variation.
After transfection of EGFP mRNA lipoplexes into HeLa cells for 24 hours, it was observed by fluorescence microscope that LP-DC-1-14/DOPE, LP-DC-1-16/DOPE, and LP-TC-1-12/DOPE all induced high EGFP expression.
Fig.2 The influence of different lipoplexes on the effect of mRNA transfection into target cells.1
A: Viral vectors have high transient efficacy but poor safety and re-dosing limits. Our custom Lipoplex/Lipopolyplex optimizes endosomal escape to boost transfection efficiency, achieving clinical efficacy with better safety for translation.
A: Yes. Our liposomal shell and polycationic core encapsulate various nucleic acid sizes; for large plasmids, we use Lipopolyplex (LPP) with polycations like Protamine for tight condensation and payload protection.
A: We use PEGylation to modify the lipid surface. This hydrophilic layer reduces non-specific protein binding/opsonization, lowers RES clearance, and helps Lipoplex reach target tissues.
A: We use modified Lipopolyplexes with targeting ligands (peptides/antibodies) for receptor-mediated BBB transcytosis, plus proprietary lipid ratios for this transport. Inquire about CNS case studies.
A: Lipoplex offers more flexibility in components/charge to improve efficacy and reduce toxicity. We provide full docs (composition, stability data) to streamline regulatory submissions and meet quality standards.
Creative Biolabs Custom Lipoplex Development Services represent the pinnacle of non-viral delivery system engineering. We transform unstable genetic material into robust, targeted nanomedicines, providing the safety profile, scalability, and specific efficacy required for the next generation of therapeutics. Trust our 20 years of expertise to accelerate your most challenging drug delivery projects, especially those targeting high-barrier sites.
Contact Our Team for More Information and to Discuss Your Project| Cat. No | Product Name | Promoter |
|---|---|---|
| CAT#: GTVCR-WQ001MR | IVTScrip™ pT7-mRNA-EGFP Vector | T7 |
| CAT#: GTVCR-WQ002MR | IVTScrip™ pT7-VEE-mRNA-EGFP Vector | T7 |
| CAT#: GTVCR-WQ003MR | IVTScrip™ pT7-VEE-mRNA-FLuc Vector | T7 |
| CAT#: GTVCR-WQ87MR | IVTScrip™ pT7-VEE-mRNA-Anti-SELP, 42-89-glycoprotein Vector | T7 |
| Cat. No | Product Name | Type |
|---|---|---|
| CAT#: GTTS-WQ001MR) | IVTScrip™ mRNA-EGFP (Cap 1, 30 nt-poly(A)) | Reporter Gene |
| CAT#: GTTS-WK18036MR | IVTScrip™ mRNA-Human AIMP2, (Cap 1, Pseudo-UTP, 120 nt-poly(A)) | Enzyme mRNA |
| (CAT#: GTTS-WQ004MR) | IVTScrip™ mRNA-Fluc (Cap 1, 30 nt-poly(A)) | Reporter Gene |
| (CAT#: GTTS-WQ009MR) | IVTScrip™ mRNA-β gal (Cap 1, 30 nt-poly(A)) | Reporter Gene |
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