CAR-T Lipid Nanoparticle Encapsulation Service

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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: A Versatile Drug Delivery Platform

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 benefits of CAR-LNP. (Khawar, et al., 2024)Fig.1 The advantages of CAR-LNP.1

Advanced LNP Encapsulation Services

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:

  • LNP Formation: Our expert team specializes in designing and optimizing lipid nanoparticle formulations to ensure the highest level of efficacy and stability for your applications. Our LNP formulation process involves the careful mixing of lipids under controlled conditions to form stable nanoparticles.
  • Encapsulation Process: We provide meticulous preparation services for lipid nanoparticles, ensuring precise and reproducible production processes. The RNA encapsulation is achieved through techniques like ethanol injection or microfluidics, wherein the IVT RNA is introduced into the lipid mixture, resulting in the formation of RNA-loaded LNPs. Our preparation processes are designed to achieve the desired particle size, uniformity, and encapsulation efficiency.
  • Characterization and Quality Control: The encapsulated LNPs are then subjected to a battery of characterization tests. Parameters such as particle size distribution, surface charge, RNA encapsulation efficiency, and stability are meticulously evaluated. This ensures that the LNPs exhibit the desired biophysical properties for efficient cellular uptake and transfection.

Fig.2 LNP Encapsulation service. (Creative Biolabs original)

Advantages of Our LNP Encapsulation Services

  • Cutting-edge technology
  • High Encapsulation Efficiency
  • Personalized service
  • Strict quality control
  • Rich expertise and professional support

What We Can Offer

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.

Analysis and testing of CAR-T Lipid Nanoparticle Encapsulation (Creative Biolabs Original)

LNP Encapsulation Workflow

Creative Biolabs' CAR-T LNP Encapsulation Service follows a rigorous, phase-appropriate workflow designed for reproducibility and regulatory compliance, from discovery through clinical application.

Workflow of CAR-T Lipid Nanoparticle Encapsulation. (Creative Biolabs Original)

Quality Control & Characterization

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

Frequently Asked Questions

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.

Client Feedback

"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.

Partner with Us

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

  1. Khawar, Muhammad Babar, et al. "Steering the course of CAR T cell therapy with lipid nanoparticles." Journal of Nanobiotechnology 22.1 (2024): 380. Distributed under Open Access license CC BY 4.0, without modification.
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