Top 5 Lipid Nanoparticles Manufacturer Providing LNP Manufacturing Contract Services

The requirement for extensive capital investment and specialized infrastructure has prompted drug developers to leverage the expertise of service providers for manufacturing of lipid nanoparticles (LNPs) We analyzed more than 50 lipid nanoparticles manufacturer that offer manufacturing services for LNPs, useful in encapsulating different types of molecules. In this article, discover top 5 lipid nanoparticles manufacturer.

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Over the years, nanoparticles have emerged as a versatile drug delivery system owing to their ability to encapsulate a wide range of therapeutics and provide their targeted / controlled release (for the treatment of several diseases). Owing to their inherent properties, such as small size, multifunctional behavior and surface tailorability, these novel nanoparticle drug delivery systems possess various advantages when compared to the conventional drug delivery systems. Moreover, many drug developers are using LNPs to re-formulate existing product candidates in order to further improve their bioavailability / biocompatibility. Lipid nanoparticles played a significant role during the COVID vaccine development by serving as a delivery platform for mRNA vaccines. Both Moderna (mRNA-1273) and Pfizer-BioNTech (BNT162b2/COMIRNATY) used Lipid nanoparticle as delivery vehicle for their COVID-19 targeted mRNA vaccines.  

However, lnp manufacturing process is complex and cost-intensive, and requires specialized technical expertise. Therefore, researchers and drug developers are actively relying on contract service providers having the technical expertise and lipid nanoparticle technology to manufacture the desired LNPs. Further, driven by the rising chronic diseases and growing demand for nanoparticle-based therapeutics, the LNP manufacturing market is anticipated to witness substantial growth during the forecast period. Additionally, the drug developers are also on the look-out for nanoparticle formulation technologies and service providers.

Roots Analysis has conducted an exhaustive study on Lipid Nanoparticle Manufacturing Market featuring the current market landscape of lipid nanoparticles manufacturer supporting the pharmaceutical industry and future opportunity associated with the LNP manufacturing market, over the forecasted period 2023-2035.

Table of Contents

Below, we have listed (in alphabetical order), the top 5 lipid nanoparticles manufacturer, based on their service portfolio / capabilities.

Company	Year of Establishment	Headquarters	Employee Count
Ascendia Pharmaceuticals	2012		11-50
Avanti Polar Lipids	1969		201-500
FormuMax Scientific	2008		2-10
leon-nanodrugs	2011		11-50
Precision NanoSystems	2010		51-200

 

Interested in exploring all 50+ lipid nanoparticles manufacturer providing contract services to the drug developers?

Through its Innovative Technologies, Ascendia Pharmaceuticals Aims to Stay at the Forefront of Contract Manufacturing in the Pharmaceutical Industry

Ascendia Pharmaceuticals is a firm that offers pre-formulation testing, formulation development and optimization, cGMP manufacturing, analytical testing and ICH-compliant stability services to various pharmaceutical companies. The company focuses on using its nanotechnology, NanoSol to enhance the solubility and bioavailability of difficult-to-formulate compounds. Additionally, the firm is engaged in the development of dispersed amorphous systems (using AmorSol), nano-emulsions (using EmulSol) and self-emulsifying lipid systems (using LipidSol).  

The following table presents the details on the services offered by Ascendia Pharmaceuticals for the manufacturing of lipid nanoparticles.

Parameter	Description
Number of Facility	1
Location of Facility	North Brunswick, New Jersey, US
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing
Type of End User	Pharmaceutical Companies
Additional Services Offered	Formulation Development

Key Strengths:
Ascendia Pharmaceuticals has two proprietary LNP technologies, namely LipidSol and NanoSol. 
1. LipidSol focuses on the encapsulation of drugs in liposomes, soli lipid nanoparticles, nanostructured lipid carriers and cationic lipid-nucleic acid complexes. 
2. NanoSol, involves the production of drug particles in nano-scale dimensions.

Recent Developments:

• In June 2023, the firm participated in BIO International 2023 Convention, held in Boston, US to showcase its proprietary nanotechnology, LipidSol.
• In April 2023, the firm participated in CPHI North America 2023 event, held in Philadelphia, US to showcase its LipidSol nanotechnology and manufacturing equipment.
• In March 2023, the firm participated in DCAT event, held in New York, US to unveil its proprietary LNP platform.

 

With a Focus on Development and Manufacturing of Lipid Components, Avanti Polar Lipids Aims to Overcome the Concerns Related to Stability and Delivery of mRNA Vaccine and Therapeutics 

Avanti Polar Lipids specializes in the research, development and commercialization of products, such as cationic lipids, PEG-lipid conjugates, synthetic neutral lipids, synthetic phospholipids, synthetic sphingolipids and lipid nanoparticles. In addition, the company has the ability to produce cargo-loaded, fluorescent, PEGylated, surface-labeled lipid formulations, or custom lipid blends useful in drug delivery and diagnostics. The company was initially founded to offer high purity lipid reagents for biomedical research; however, since 1985 it has been providing GMP manufacturing services.

The following table presents the details on the services offered by US based lipid nanoparticles manufacturer Avanti Polar Lipids for the manufacturing of lipid nanoparticles.

Parameter	Description
Number of Facility	1
Location of Facility	Alabama, US
Facility Size (sq ft)	80,000
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Molecule Delivered	Nucleic Acid (mRNA and siRNA) Proteins / Peptides Small Molecules
Additional Services Offered	Process Development / Pre-formulation Formulation Development Analytical Testing  Stability Studies Scale-Up Regulatory Support Packaging

Key Strengths:
The facilities of Avanti Polar lipids are FDA approved, and provide more than 2,000 unique lipids, antibodies as well as lipid research tools.¹ 

Recent Developments:
Avanti Polar Lipids aims to explore the complete potential of lipid technology, and develop innovative, safe, and effective pharmaceutical delivery systems. The company collaborates with other industry players, and offers support in product design, clinical development and manufacturing.

 

FormuMax Scientific, Strives to Provide Safe and Effective Solutions for Nucleic Acids and Complex Compounds Delivery

FormuMax Scientific is engaged in offering formulation development services to different industries, including biotechnology, cosmetic, pharmaceutical and nutraceutical. The company focuses on providing effective drug delivery solutions using stealth (PEGylated) liposomes and other innovative lipid-based nanotechnologies. 

The following table presents the details on the services offered by California based lipid nanoparticles manufacturer, FormuMax Scientific for the manufacturing of lipid nanoparticles.

Parameter	Description
Number of Facility	1
Location of Facility	San Francisco, California, US
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing
Type of Molecule Delivered	Nucleic Acid (mRNA and siRNA)
Type of End User	Pharmaceutical Companies
Additional Services Offered	Process Development / Pre-formulation Formulation Development Analytical Testing  Scale-Up

Key Strengths:

• The company provides a range of contract services, including basic research, customized formulation and characterization services for particle size and shape, assessment of drug encapsulation efficiency, microscopic examination and polymer glass transition.  
• It claims to develop LNPs having high mRNA encapsulation efficiency (80-95%).

 

leon-nanodrugs Facilitates Efficient and Flexible GMP Manufacturing Through its Proprietary Devices

leon-nanodrugs is a Germany based company specializing in the development and manufacturing of novel, advanced pharmaceutical drugs and therapies. The company has developed an aseptic device, NANOus for the encapsulation of genetic medicines; it claims to have the ability to produce 6-8 million vaccine doses per day, thereby allowing fast delivery of the products to the market.² It’s proprietary technology, NANOsolv is useful in synthesizing SMART nanoparticles or microparticles.  

The following table presents the details on the services offered by Germany based lipid nanoparticles manufacturer, leon-nanodrugs, for the manufacturing of lipid nanoparticles.

Parameter	Description
Number of Facility	1
Location of Facility	Munich, Bavaria, Germany
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Molecule Delivered	Nucleic Acid (mRNA)
Therapeutic Area	Oncological Disorders
Additional Services Offered	Process Development / Pre-formulation Scale-Up

Key Strengths:
The company strives to implement its automated nanoparticle-based technology in manufacturing innovative cancer therapies and vaccines.

Recent Developments:

• In February 2023, the company announced the establishment of new lab facilities in Munich, Germany to support late-stage product development for their proprietary LNP-based devices.
• In January 2023, the company completed the development of its novel reactor, facilitating the efficient production of LNPs.
• In October 2022, the company entered into an agreement with Harro Hofliger to manufacture a LNP system, NANOus useful in encapsulating mRNA or active pharmaceutical ingredients.

 

With an Aim to Significantly Impact the Wellbeing of Humans, Precision NanoSystems Uses LN Technology to Develop Therapeutics and Vaccines

Precision NanoSystems, a subsidiary of Cytiva, provides advanced technologies, solutions and services to develop novel LNP-based genomic therapies for cancer, infectious diseases and rare diseases. The company provides a complete suite of services, ranging from discovery to large-scale manufacturing, of various drug carriers, including lipid and polymeric nanoparticles, and liposomes. In addition, its proprietary technology, NxGen enables reproducible scale-up of mRNA-LNP formulations.  

The following table presents the details on the services offered by Precision NanoSystems for the manufacturing of lipid nanoparticles.

Parameter	Description
Number of Facility	1
Location of Facility	Vancouver, British Columbia, Canada
Scale of Operation	Preclinical Manufacturing Clinical Manufacturing Commercial Manufacturing
Type of Molecule Delivered	Nucleic Acid (DNA, mRNA, saRNA and siRNA) Proteins / Peptides Small Molecules Viruses
Therapeutic Area	Cardiovascular Disorders  Oncological Disorders
Additional Services Offered	Process Development / Pre-formulation Formulation Development Analytical Testing  Stability Studies Scale-Up Regulatory Support

Key Strengths:

1. The company's capabilities specific to LNP characterization include assessment of encapsulation efficiency, in vitro potency, particle size distribution, pH, total drug substance content, osmolality and zeta-potential. 
2. It is important to mention that the company claims to out-license its lipid delivery technology to different CMOs for the development and manufacturing of mRNA vaccines, cell therapies and gene therapies.

Recent Developments:

• In July 2023, Cytiva launched NanoAssemblr, a formulation system that enables clinical and commercial manufacturing of LNP drugs; the single-use fluid path of the system enhances production by preventing cross-contamination and minimizing time spent on sanitizing / cleaning validation, and allows manufacturing of various LNP formulations within the same plant.³  
• In July 2022, the lipid nanoparticles manufacturer, Precision NanoSystems entered into an agreement with Replicate Bioscience to license its LNP technology to the latter company, for accelerating the development, scale-up and delivery of srRNA therapies.
• In June 2022, the company entered into an agreement with Aurora Vaccines to offer its proprietary LNP platform to speed up the development and manufacturing of the later company’s Hepatitis C vaccine candidate.
• In May 2022, the company launched an innovative LNP Reagent to scale up the delivery of RNA into the T-cells.

What About the Other Lipid nanoparticles manufacturers?

The above presentation features five lipid nanoparticle manufacturing companies selected from a pool of over 50 companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

About Author

Simran Kaur

Simran, a Senior Business Analysis, has been an integral part of the Roots Analysis team since 2020. Holding a Master’s and Bachelor’s in pharmacy from a prestigious institution, she embarked on her professional journey with a strong academic foundation and an interest in life sciences domain. Her keenness to learn more about the emerging trends, regulatory dynamics and technological advancements enables her to provide comprehensive analyses. Till date, she has diligently contributed to over 15 comprehensive research reports on trending topics, ranging from anti-aging therapeutics, allogeneic cell therapies, lipid nanoparticles, pre-sterilized pharmaceutical packaging to next generation sequencing kits. 

Sources:1 https://www.sigmaaldrich.com/IN/en/products/chemistry-and-biochemicals/biochemicals/avanti-polar-lipids
Sources:2 https://www.harro-magazine.com/en/wp-content/uploads/sites/19/2022/12/Harro13_EN_think-nano.pdf
Sources:3 https://www.precisionnanosystems.com/news-room/detail/cytiva-launches-first-formulation-system-to-enable-end-to-end-clinical-and-commercial-manufacturing-of-lipid-nanoparticle-medicines