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CAR IVT RNA and LNP Manufacturing Services

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All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.

Chimeric Antigen Receptor T-cell (CAR-T) therapy has revolutionized the field of cancer treatment by leveraging the patient's immune cells to abate malignancies. This innovative treatment involves reprogramming T cells to express CARs that can specifically target cancer cells. CAR-T therapy has shown remarkable success in treating certain types of leukemia and lymphoma, offering hope to patients who have exhausted conventional treatment options. At Creative Biolabs, we are committed to advancing this promising therapeutic area by providing global Contract Development and Manufacturing Organization (CDMO) services for CAR-T therapies, ensuring high-quality and efficient production processes.

Our Platforms

Fig.1 IVT RNA Platform. (Creative Biolabs original)

IVT RNA Platform

Our IVT RNA service utilizes advanced IVT technology to produce high-quality RNA quickly and efficiently, ensuring optimal purity and yield for a variety of applications.

View Research Grade (RG) mRNA→

View GMP-like mRNA→

View GMP Grade mRNA→

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

LNP Encapsulation Platform

our LNP encapsulation service is designed to optimize the delivery of RNA and other therapeutics. Our state-of-the-art technology ensures efficient encapsulation, enhancing stability and bioavailability while minimizing degradation.

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CAR IVT RNA Production Platform

The production of CAR IVT RNA is a critical step in the development of CAR-T therapies. In vitro transcription (IVT) RNA encompasses a suite of synthetic RNA sequence production techniques that are essential for expressing CAR constructs. Our state-of-the-art CAR IVT RNA manufacturing platform at Creative Biolabs is accurately designed to deliver high-purity, high-quality RNA products that cater to various stages of research and clinical development. This platform ensures the scalability and reproducibility of CAR IVT RNA. We employ advanced technologies such as high-fidelity RNA polymerases, optimized transcription conditions, and rigorous purification methods to achieve superior RNA yields and functionality.

Our platform provides various grades of CAR IVT mRNA, ensuring that every project has a tailored solution:

Research Grade (RG) mRNA GMP-like mRNA GMP Grade mRNA
Purpose Used for basic research and early-stage development Suitable for preclinical studies and preliminary clinical investigations Used for clinical trials and commercial applications
Quality Control Limited QC testing Intermediate level of QC testing to ensure product consistency and quality Comprehensive QC testing, including purity, potency, and safety assessments
Regulations Do not conform to GMP standards Partially conforms to GMP standards, making it more rigorous than research-grade but not fully GMP-compliant Fully GMP-compliant, adhering to strict regulatory requirements
Scale Typically small-scale production Scalable production suitable for clinical study needs Large-scale production to meet clinical and commercial demands

CAR-LNP Encapsulation Platform

Lipid Nanoparticle (LNP) technology represents an advanced approach to the delivery of RNA therapeutics. LNPs enhance the stability and delivery efficiency of therapeutic RNAs, ensuring their successful transport into target cells. At Creative Biolabs, our CAR-LNP platform integrates cutting-edge techniques to formulate and characterize LNP-encapsulated CAR RNAs. Our platform focuses on key aspects such as lipid composition optimization, particle size control, encapsulation efficiency, and in vitro/in vivo delivery performance. We provide comprehensive solutions from formulation development to scale-up manufacturing. This ensures that the CAR RNA payloads are protected from degradation and delivered precisely to the intended cells, maximizing therapeutic efficacy.

One-stop IVT RNA and LNP Manufacturing Services

At Creative Biolabs, our workflow for CAR IVT RNA and LNP manufacturing services begins with the design and synthesis of the CAR construct, followed by the in vitro transcription to produce high-fidelity CAR RNA. This RNA is then subjected to rigorous purification protocols to remove impurities. Concurrently, our LNP formulation specialists develop and optimize LNP carriers tailored for the specific CAR RNA payloads. The encapsulation process involves incorporating the purified CAR RNA into LNPs under controlled conditions to achieve the desired encapsulation efficiency and particle size. Once the formulation is complete, the CAR-LNP product undergoes extensive characterization to evaluate parameters such as particle size distribution, particle concentration, encapsulation efficiency, payload analysis, and stability. We employ advanced analytical techniques to ensure the consistent quality and functionality of the CAR-LNPs.

Working with Creative Biolabs

Our integrated workflow ensures a seamless and streamlined process from initial design to final production, providing our clients with reliable and robust manufacturing solutions for their CAR-T therapeutic development needs. Creative Biolabs is dedicated to supporting the advancement of CAR-T therapies, offering expertise and state-of-the-art technologies to propel groundbreaking cancer treatments forward. Contact us for more about our IVT RNA and LNP manufacturing services.

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