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Carcell Biopharma
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Delivering next-generation
nucleic acid-based medicines

Our Mission


Customized Lipid Nanoparticles (LNPs)

for every nucleic acid-based drug

 

Is your delivery vehicle bringing your payload to the target tissue(s), obtaining a good level of protein expression among majority of the cells in that tissue,

with a good safety profile?  

 

If not, your delivery vehicle is probably not optimized for your payload, target tissue or route of administration.

 

Conventional wisdom in the lipid nanoparticle (LNP) field takes a one-lipid-fits-all approach for a variety of applications. However, this often yields undesirable results.

 

Carcell develops bespoke LNP formulation uniquely tailored for your application. From bench to bedside, our team has deep industry expertise in lipid discovery, formulation development and manufacturing to cater to your unique LNP needs.

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What We Do


Lipid licensing & LNP R&D services for your nucleic acid-based drug

 

"Time is money" is especially true in drug development, and therefore time and cost efficiency is at the heart of our business. Depending on your specific LNP needs, Carcell has a range of solutions for you (hover over the boxes):

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Licensing

Licensing only

Carcell has a library of >1000 proprietary ionizable lipids to choose from. These lipids have been tested rigorously in vivo for potency and safety, benchmarking them against some of the lipids found in commercial-stage LNP formulations. â€‹

 

We will work with you to identify the optimal lipid that can be combined with your payload to create your drug candidate. The licensing is typically structured on a "per target" basis. 

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Co-development & licensing

We can also work with your in-house R&D team to co-develop novel lipids and/or formulation. Some of our in-house formulation capabilities enable:

  • Increased potency 

  • Repeated dosing (PEG-free formulations)

  • Tissue-targeting (surface modifications)

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Services

Contract Services

Carcell offers an end-to-end suite of services on a fee-for-service (FFS) model:

  • Lipid discovery and customized lipid synthesis

  • Encapsulation of payloads into LNPs

  • LNP composition optimization, and/or formulation process development

  • In vivo testing in rodents and non-human primates (NHPs)

  • Research- or GMP-grade manufacturing

  • Project management at different stages of drug development.

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Why Work With Us


We take pride in our LNP capabilities &
bring you 
tremendous value

Our Science


What Are LNPs?

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Lipid nanoparticles (LNPs) are advanced drug delivery vehicles composed of lipid-based materials, typically ranging in size from 10 to 200 nm. These nanoparticles act as carriers for therapeutic payloads, such as nucleic acids, facilitating their delivery to target tissues in the body while providing the payload protection against drug degradation and enhancing stability in circulation. Depending on the formulation, LNPs can be administered in a variety of ways including intravenous and intramuscular administration.

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Ionizable lipids play a crucial role in the functionality and unique characteristics of LNPs. These are lipids that carry a positive charge at low pH due to the presence of amino or guanidino groups in their structure. This positive charge distinguishes ionizable lipids from other lipid components in the LNP formulation and determines the encapsulation of various payloads and cellular uptake of LNPs in various tissues.

 

LNPs have diverse applications in various medical fields:

  • Gene therapy: Deliver RNA, DNA or gene editing tools to modulate gene expression or correct genetic defects

  • Vaccine development: Induce immunity towards antigens of infectious diseases or cancers

  • Cancer therapy: Deliver anticancer drugs to tumor sites, and transfect immune cells to express signaling receptors to eradicate tumors

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Due to their ability to deliver disease-modifying nucleic acid therapies coupled with their potential applications in personalized medicine, LNPs hold great promise for improving therapeutic outcomes and patient well-being.

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Our Approach


Problem: Delivering drugs with unoptimized LNPs because LNP discovery is historically an inefficient process

Ball and stick figure showing a chemical structure
In vitro versus in vivo
Various routes of administration

Little structure-activity-relationship in lipid design

Little correlation between
in vivo and in vitro results

Lack of customized LNP for different payloads & route of administrations (RoAs)

Solution: Our LNP platform that pushes current boundaries and yields customized LNPs for different applications

Lipid library vault
High throughput screening
Customizing LNP solutions

Highly productive lipid library development

High throughput formulation
in vivo screening

Customized LNPs for various payloads and RoAs

How: We perform high throughput screening in vivo to find you the right lipid you need

 

Carcell has a rapidly growing vault of novel and proprietary ionizable lipids. We test the potency and distribution of these lipids in mice and compare them to commercial benchmarks such as ALC-0315, SM-102 and MC3. The top performers are subjected to further scrutiny such as tolerability

studies and freedom-to-operate (FTO) analysis.

>2000

Lipids in our vault

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Formulations can be screened in vivo in a single day

Choosing and filtering the best lipid nanoparticles (LNPs) from a range of LNPs via high throughput screening in vivo

>200

New lipids synthesized & screened in vivo every month

>5x

More potent than industry benchmarks (top performers)

 

With multiple shots on goal in our iterative lipid discovery and screening process, depending on your needs, we will find the LNP most suited for your application.

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Our LNPs undergo rigorous analytical testing to ensure that the data generated is robust and reproducible. We ensure that our LNPs meet and even exceed industry standards:

  • Average molecular weight

  • CAD purity of > 95%

  • Size of < 100 nm

  • Polydispersity Index (PDI) of < 0.2

  • Encapsulation rate of > 90%

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Quality control parameters for lipid nanoparticle (LNP) manufacturing
Proces Development

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We also supercharge your LNP with formulation development:

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Besides the choice of ionizable lipid, there are many other knobs to turn. Mixing geometry and rate, buffer composition and concentration, temperatures etc. need to be carefully controlled. At Carcell, we combine our library of process development methods with our high throughput LNP formulation instrument to rapidly screen for the optimal production process for your LNP.

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T-mixing of lipid nanoparticles (LNPs) by carefully titrating and introducing lipids and nucleic acids
Shanghai

 

Due to our highly cost-efficient R&D, we have the ability to pass our cost-savings to our clients and offer one of the most competitive prices globally.

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Working With Us


Customized or off-the-shelf LNPs?
We have you covered!

 

When developing your bespoke LNP, we will consider all of the following factors:

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Target
Tissue

Route of
Administration

Payload/

Application

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We also have off-the-shelf LNPs available for licensing, with advanced data for their specific applications:

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We also provide curated high throughput screening panels for specific applications for finding the best lipid for your needs:

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With better lipids discovered every month, we will update these panels to ensure that the best lipids are available for testing. We build specific panels to cater to our partners’ bespoke applications and will expand the number of panels in the time to come. Depending on the specific needs of our partners, we could also encapsulate other payloads such as proteins/peptides and small and large molecules.

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Carcell - Your Nucleic Acid Delivery Team

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At Carcell, we work closely with our partners to help them achieve their drug delivery goals. 

We place emphasis on delivering high quality work to our clients. 

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Typically, we will establish first contact with an introductory call to better understand the intricacies of your project. Subsequently, we will initiate a feasibility study via a material transfer agreement (MTA) as your first trial of our lipids. Upon successful evaluation, we become partners as we establish an official collaboration, eventually leading to your licensing of our proprietary lipids and/or engaging our services.

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First
Contact

Identifying
Your Needs

Evaluation
Phase

Working
Together

 

 

We work closely with our partners to make your drug delivery project a reality:

 

 

 

Contact us now for a non-obligatory discussion on your nucleic acid delivery needs!

 

Let's Collaborate

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© 2024 Carcell Biopharma
All Rights Reserved

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