Lipid-based Nanoparticles for the Pharmaceutical Industry: Pre-clinical and Clinical Advancements

Lipid-based Nanoparticles for the Pharmaceutical Industry: Pre-clinical and Clinical Advancements

Varied Lipid Composition, Improved Temperature Stability, and Efficient Manufacturing Drive Product Commercialization

RELEASE DATE
18-Oct-2022
REGION
Global
Deliverable Type
Technology Research
Research Code: DA6E-01-00-00-00
SKU: CM01981-GL-TR_26995
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CM01981-GL-TR_26995

Lipid-based Nanoparticles for the Pharmaceutical Industry: Pre-clinical and Clinical Advancements
Published on: 18-Oct-2022 | SKU: CM01981-GL-TR_26995

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In the last decade, nanomedicine and nanotechnology have helped unlock revolutionary therapeutic potential that has positively impacted healthcare. Among the different nanotechnology-based innovations, lipid-based nanoparticles such as liposomes and lipid nanoparticles (LNPs) show great promise across multiple therapies. Although the Food and Drug Administration (FDA) approved the use of liposomes for the delivery of cancer drug therapeutics in the early 90s, the recent breakthrough in use of LNPs for mRNA vaccine delivery for COVID-19 has created high interest in LNPs from pharmaceutical companies worldwide. Contract manufacturing of LNPs with diverse phospholipids of different surface charge and effective methods of stabilizing the lipid-based carriers using stabilizers such as cholesterols and emulsifiers to maintain size and drug-loading efficiency are the key focus areas in industrial R&D.

LNPs are chosen widely for drug/vaccine delivery due to their ease in formulation and high biocompatibility in comparison with other polymeric nanocarriers. LNPs have brough a radical change in the treatment of cancer therapy, ensuring improved drug delivery to the target site with minimal side effects. Importantly, LNPs can cross the blood-brain barrier (BBB) to improve drug delivery in treating brain tumors or neurodegenerative diseases. Apart from therapeutics, use of LNPs for the delivery of nucleic acids, such as pDNA, mRNA, and siRNA, has gained profound interest and potential in demonstrating high capabilities in viral vaccine delivery. The LNPs offer stability and protection to the mRNA, ensuring better efficacy and enhanced immune response. The last decade witnessed progress in LNPs used for treating complex diseases and as preventative vaccines; however, regulations of LNPs and their large-scale production for uniform size, shape, and product stability limit wide-scale adoption. The commercialization of LNPs for therapeutic and vaccine delivery holds major promise in transforming global health issues when supported by good manufacturing practices, regulations, and quality control analysis for better clinical translation.

This study offers an in-depth analysis of the current research and industrial developments in use of lipid-based nanoparticles. Focus areas include key advancements in R&D for the pre-clinical and clinical stages of LNP development for use in therapeutic delivery for different diseases such as cancer, cardiovascular, and neurodegenerative disorders. The use of LNPs as an mRNA carrier for vaccine delivery is discussed, providing insights on industrial adoption and future perspective. In addition, the research highlights the challenges and the drivers; important policies; innovations; and key market participants in LNP production and utilization.

This research answers the following questions:

What are the current research advancements in use of LNPs for therapeutic and vaccine delivery?
What is the current scenario and progress made in industrial manufacturing and adoption of LNPs?
What are the advancements in optimizing stability, targeting ability, formulation, manufacturing, and storage of LNP-based therapeutics?
What initiatives are industry participants undertaking to accelerate adoption?
What are the expected outcomes in use of LNPs in the pharmaceutical sector, and how does it help to resolve global health challenges?

Why Is It Increasingly Difficult to Grow?The Strategic Imperative 8™: Factors Creating Pressure on Growth

The Strategic Imperative 8™

The Impact of the Top 3 Strategic Imperatives on the R&D Advances for Lipid Nanoparticles in the Pharmaceutical Industry

Growth Opportunities Fuel the Growth Pipeline Engine™

Research Methodology

Lipid-Based Nanoparticles: Overview and Significance

LNPs Are Better Suited than Liposomes for Nucleic Acid Delivery

Next-generation Lipid-based Nanocarriers Display Promising Attributes in Encapsulation and Large-scale Production

Second-generation LNPs Offer Better Design Flexibility and Improved Stability

Second-generation LNPs Offer Better Design Flexibility and Improved Stability (continued)

First-generation Lipid-based Nanoparticles Are Used Widely in the Cosmetics, Food & Beverage, and Nutraceuticals Industries

Research Scope

Segmentation

Growth Drivers

Growth Restraints

LNPs Constitute a Mix of Lipids and Stabilizers

Approved LNP Formulations Encapsulate Diverse Cargo of Different Chemical & Physical Properties

Mixing Ratio of Lipids and Aqueous Phase Critically Determine the Size of LNPs and their Entrapment Efficiency

High Pressure Homogenization Is the Preferred Choice for Large-scale Manufacturing of LNPs

Microfluidics and Super Critical Fluid Technology Offer Improved Control over Particle Size and Distribution

Formulation Techniques Play a Critical Role in Determining Size, Solvent Residue, and Distribution

Active and Passive Targeting of LNPs Exhibit Improved Cellular Penetration of Therapeutics with Minimal Systemic Toxicity

Rational Design of Lipids for Improved In Vivo Stability of mRNA Vaccines and Therapeutics Drives Commercialization

Lipid-based Nanocarriers Increasingly Used in the Treatment of Various Diseases

LNPs Conjugated with Antibody/Ligands Exhibit High Specificity for Cancer Targeting

Design and Use of New Phospholipid Combinations, Linkers, and Cholesterol Alternatives Improve In Vivo Stability, Safety, and Transfection of LNPs

Lipid and Polymer Hybrid LNPs offer Synergistic Benefits with Improved Stability and Targeting

In-line Detection and Tracking of LNPs Formulation Minimizes Production Time and Enables Process Feedback Control

Intramuscular and Intravenous Routes of Delivery Are Most Preferred for LNP-based Therapeutics

Surface Modification of LNPs and Lyophilization of Lipids and Cargo Exhibit Improved Stability for Long-term Storage

North America Secures High Funding for Commercial Development of LNP-based Therapeutics

Private Funding Focuses on Improved LNP Formulations for Vaccines and Immunotherapeutics

Entry of Thermostable and Targeted LNPs-based Therapeutics into Clinical Trials

Pharmaceutical Companies Innovate in the Stability, Biodegradation, Formulation, and Cost-Effectiveness of LNPs

Lipid Manufacturers Collaborate with API Developers to Leverage LNP-based Therapeutics

Therapeutic and Vaccine Formulations Using LNPs Are in Different Phases of Clinical Trial

North America Holds Highest Share of Patent Filings for LNPs

Leading LNPs and mRNA Players Battle on Patent Infringement

Growth Opportunity 1: In-silico and AI-based Lipid Composition Prediction

Growth Opportunity 1: In-silico and AI-based Lipid Composition Prediction (continued)

Growth Opportunity 2: Formulation of Stable LNPs with Improved Functionality

Growth Opportunity 2: Formulation of Stable LNPs with Improved Functionality (continued)

Growth Opportunity 3: Automated and Microfluidics-based LNP Manufacturing Platform

Growth Opportunity 3: Automated and Microfluidics-based LNP Manufacturing Platform (continued)

Growth Opportunity 4: Directed Development of LNPs for Tissue-targeted Delivery

Growth Opportunity 4: Directed Development of LNPs for Tissue-targeted Delivery (continued)

Technology Readiness Levels (TRL): Explanation

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In the last decade, nanomedicine and nanotechnology have helped unlock revolutionary therapeutic potential that has positively impacted healthcare. Among the different nanotechnology-based innovations, lipid-based nanoparticles such as liposomes and lipid nanoparticles (LNPs) show great promise across multiple therapies. Although the Food and Drug Administration (FDA) approved the use of liposomes for the delivery of cancer drug therapeutics in the early 90s, the recent breakthrough in use of LNPs for mRNA vaccine delivery for COVID-19 has created high interest in LNPs from pharmaceutical companies worldwide. Contract manufacturing of LNPs with diverse phospholipids of different surface charge and effective methods of stabilizing the lipid-based carriers using stabilizers such as cholesterols and emulsifiers to maintain size and drug-loading efficiency are the key focus areas in industrial R&D. LNPs are chosen widely for drug/vaccine delivery due to their ease in formulation and high biocompatibility in comparison with other polymeric nanocarriers. LNPs have brough a radical change in the treatment of cancer therapy, ensuring improved drug delivery to the target site with minimal side effects. Importantly, LNPs can cross the blood-brain barrier (BBB) to improve drug delivery in treating brain tumors or neurodegenerative diseases. Apart from therapeutics, use of LNPs for the delivery of nucleic acids, such as pDNA, mRNA, and siRNA, has gained profound interest and potential in demonstrating high capabilities in viral vaccine delivery. The LNPs offer stability and protection to the mRNA, ensuring better efficacy and enhanced immune response. The last decade witnessed progress in LNPs used for treating complex diseases and as preventative vaccines; however, regulations of LNPs and their large-scale production for uniform size, shape, and product stability limit wide-scale adoption. The commercialization of LNPs for therapeutic and vaccine delivery holds major promise in transforming global health issues when supported by good manufacturing practices, regulations, and quality control analysis for better clinical translation. This study offers an in-depth analysis of the current research and industrial developments in use of lipid-based nanoparticles. Focus areas include key advancements in R&D for the pre-clinical and clinical stages of LNP development for use in therapeutic delivery for different diseases such as cancer, cardiovascular, and neurodegenerative disorders. The use of LNPs as an mRNA carrier for vaccine delivery is discussed, providing insights on industrial adoption and future perspective. In addition, the research highlights the challenges and the drivers; important policies; innovations; and key market participants in LNP production and utilization. This research answers the following questions: What are the current research advancements in use of LNPs for therapeutic and vaccine delivery What is the current scenario and progress made in industrial manufacturing and adoption of LNPs What are the advancements in optimizing stability, targeting ability, formulation, manufacturing, and storage of LNP-based therapeutics What initiatives are industry participants undertaking to accelerate adoption What are the expected outcomes in use of LNPs in the pharmaceutical sector, and how does it help to resolve global health challenges
More Information
Deliverable Type Technology Research
Author Ramya kannan
Industries Chemicals and Materials
No Index No
Is Prebook No
Podcast No
WIP Number DA6E-01-00-00-00