The use of lipid nanoparticles (LNPs) technology in CAR-T therapy represents a significant advancement, offering improved delivery, reduced immunogenicity, and scalable manufacturing options. These advantages collectively enhance the efficacy, safety, and accessibility of CAR-T therapies, promising better outcomes for patients with various forms of cancer. At Creative Biolabs, we offer a comprehensive suite of IVT RNA and LNP manufacturing services designed to maximize the efficacy and safety of CAR-T therapy.
LNPs have emerged as a critical technology in the delivery of therapeutic agents, including nucleic acids such as RNA. At Creative Biolabs, we offer advanced LNP encapsulation services designed to optimize the delivery and functionality of IVT RNA in CAR-T cell therapy. Our services are meticulously designed to support the development and production of high-quality LNPs that are essential for the encapsulation and delivery of mRNA and other genetic cargo involved in CAR-T therapy. By leveraging our state-of-the-art technology and expertise, we ensure that the LNPs produced are highly efficient, stable, and capable of delivering their cargo with high specificity and minimal side effects. Our one-stop service covers every stage of LNP production, from initial design and formulation to scaling up for clinical and commercial use, ensuring that each product meets rigorous quality standards and regulatory requirements.
Fig.1 The advantages of CAR-LNP.1
LNPs have emerged as a critical technology in the delivery of therapeutic agents, including nucleic acids such as RNA. At Creative Biolabs, we offer advanced LNP encapsulation services designed to optimize the delivery and functionality of IVT RNA in CAR-T cell therapy. Our services are meticulously designed to support the development and production of high-quality LNPs that are essential for the encapsulation and delivery of mRNA and other genetic cargo involved in CAR-T therapy. By leveraging our state-of-the-art technology and expertise, we ensure that the LNPs produced are highly efficient, stable, and capable of delivering their cargo with high specificity and minimal side effects. Our one-stop service covers every stage of LNP production, from initial design and formulation to scaling up for clinical and commercial use, ensuring that each product meets rigorous quality standards and regulatory requirements.
We utilize state-of-the-art techniques and materials to create tailor-made solutions for LNP encapsulation, including:
Creative Biolabs provides comprehensive LNP optimization and CAR LNP-RNA functional validation services to expedite the development of next-generation non-viral CAR delivery systems. Our platform ensures optimal physicochemical properties and robust in vitro and in vivo functional performance.
Creative Biolabs' CAR-T LNP Encapsulation Service follows a rigorous, phase-appropriate workflow designed for reproducibility and regulatory compliance, from discovery through clinical application.
Each LNP formulation undergoes rigorous quality control to ensure reproducibility and compliance with preclinical or GMP-compatible standards.
| Parameter | Specification | Method |
|---|---|---|
| Particle Size (Z-avg) | 80 – 120 nm | Dynamic Light Scattering |
| Polydispersity Index (PDI) | ≤ 0.20 | Dynamic Light Scattering |
| Zeta Potential | −5 to +10 mV | Electrophoretic light scattering |
| Encapsulation Efficiency | ≥ 90 % | RNA fluorescence assay |
| RNA Integrity | ≥ 95 % intact | Agilent Bioanalyzer |
| Residual Ethanol | ≤ 0.5 % | Gas Chromatography |
| Endotoxin | ≤ 0.1 EU/µg RNA | LAL assay |
| Sterility | Pass | USP <71> |
| Storage Stability | ≥ 6 months −80 °C / 4 weeks 4 °C | Accelerated stability study |
What types of nucleic acids can be encapsulated?
We support mRNA, saRNA, siRNA, sgRNA, and plasmid DNA formulations. Custom payloads are also accepted upon request.
Do you provide formulation optimization services?
Yes. We can tailor lipid composition, N/P ratio, and process parameters to achieve optimal encapsulation efficiency or delivery performance.
Are your LNPs suitable for in vivo studies?
Yes. We provide in vivo-grade formulations with endotoxin-controlled and sterile-filtered materials suitable for preclinical testing.
What kind of analytical reports do clients receive?
Clients receive a full Certificate of Analysis (CoA) including DLS data, encapsulation rate, RNA integrity, and stability results.
"Creative Biolabs delivered highly reproducible LNP-mRNA batches with >95 % encapsulation efficiency. Their rapid turnaround helped us accelerate our CAR-T proof-of-concept study." — P**S.
"Excellent communication and technical documentation. The LNP formulations showed consistent particle size across batches."— S**C.
Creative Biolabs is your end-to-end partner for next-generation CAR-T therapeutics, providing a comprehensive suite of services focused on Lipid Nanoparticle delivery. Our core offerings include custom LNP formulation and optimization, synthesis of clinical-grade mRNA and DNA payloads, high-yield encapsulation services, and GMP manufacturing for phase I/II clinical trials. We deliver the high-quality, regulatory-compliant material essential for achieving successful systemic CAR-T programming.
Ready to discuss how highly engineered LNPs can unlock the potential of your CAR-T program? Our team of specialist scientists is available to provide detailed consultation and tailor a service plan to your exact project specifications.
Reference
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All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.
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