Lipid Nanoparticle
Portfolio
Our lipid nanoparticle (LNP) portfolio provides access to off-the-shelf kits and custom formulations for developing nucleic acid therapeutics that seamlessly transition from discovery to the clinic. Rationally design LNP formulations to validate active pharmaceutical ingredients (APIs), generating proof-of-concept and efficacy data that allows progression of lead candidates quickly through screening and in vivo preclinical studies to accelerate clinical evaluation.
In addition to liposomes and polymeric nanoparticles (poly(lactic-co-glycolic acid) PLGA) nanomedicines, LNP delivery technology is clinically proven with mRNA delivery for gene therapy through Onpattro, COVID-19 vaccines and is currently in clinical trials for several cell therapy applications including CRISPR-Cas9 gene editing, protein replacement therapy and more. Precision NanoSystems offers an easily accessible and well characterized lipid nanoparticle portfolio and nanomedicine formulation technologies for these applications and future RNA-based therapeutics.
In genomic medicines, the drug delivery challenge is getting the active pharmaceutical ingredient (API) into the target cells at the disease site. Lipid nanoparticles (LNPs) are an elegant solution for DNA or RNA delivery as they protect the cargo
from degradation and mediate a safe and targeted intracellular delivery.
Lipid nanoparticles consist of ionizable cationic lipids, helper lipids, cholesterol, and stabilizers, each having a specific role in delivery of the genomic medicine to its site to activation. Due to their modular nature, excipients can be mixed, matched, and modified during LNP formulation to target different organs in the body and improve the encapsulated drug's efficacy and pharmacokinetic profile.
In particular, ionizable lipids offer a unique capability to shift charge with pH changes to ensure strong binding of nucleic acids during LNP formulation while maintaining a neutral charge under physiological pH to limit cytotoxic effects. They are the main component that enable efficient cellular delivery and overcome payload size limitations. Access to a lipid nanoparticle portfolio with an array of ionizable cationic lipids allows for LNP optimization for targeted nanomedicines.
Read more about research focused on individual excipients and their role in RNA delivery and LNP delivery strategies to discover how lipid nanoparticles properties can affect function.
Alterations in the chemical structure and ratio of the LNP components affect its delivery efficiency, potency, and biodistribution, making it essential to optimize lipid nanoparticles for each application so that it is Fit-For-Purpose. LNP formulations are not one-size-fits-all, as ionizable cationic lipids that are effective for mRNA vaccines may not be well-suited for gene editing or cell therapies.
Aside from safety and potency, optimizing ionizable lipids for structural properties, targeted RNA delivery and immunomodulation can be labour-intensive. Access to a lipid nanoparticle portfolio that includes systematic categorization of these lipids allows for rationally designed custom LNP formulations that help developers quickly reach the full potential of nucleic acid therapeutics across applications.
Accelerate Preclinical and Clinical Drug Development
Our end-to-end Genomic Medicine Tool Kit uniquely enables access to ionizable lipid mixes through the lipid nanoparticle portfolio, LNP technologies and proven expertise, to establish robust in-house strategies and infrastructure. This results in a sustainable LNP formulation and manufacturing framework that accelerates drug candidates across indications from discovery to the clinic.
Nucleic acid therapeutics including mRNA-LNP vaccines, gene therapy, cell therapy and more, demand different characteristics and indications from lipid nanoparticles, requiring fit-for-purpose optimization to produce effective nanomedicines. To accelerate development, the lipid nanoparticle portfolio offers off-the-shelf LNP formulations designed for specific applications with a clear path to the clinic, and proven expertise in biopharma services to help in selecting appropriate ionizable cationic lipids for custom applications.
These easy-to-use kits or custom formulations enable any researcher to become a genomic medicine developer as they offer ionizable lipids for broad or targeted applications. This saves significant time for validation of target payloads and lowers the risk of developing a bespoke lipid nanoparticle formulation, accelerating preclinical programs for lipid-based therapeutics.
Nanomedicine developers must successfully file regulatory documentation before conducting clinical trials on cutting-edge novel medicines. Therefore, submitting an Investigational New Drug (IND) application for RNA therapeutics to the FDA is a significant milestone.
For a successful IND filing, it is possible to prepare for scale-up and manufacturing processes during each development phase to streamline the overall process. Starting with the end in mind, and identifying clinical goals at the outset allows researchers to establish preclinical programs that generate supporting data and manufacturing strategies at each stage, strengthening the IND filing and accelerating the path to clinical development.
Partner with Precision NanoSystems to maximize the probability of commercial success through access to our lipid nanoparticle portfolio, nanomedicine technologies, and LNP formulation expertise to optimize and accelerate drug candidates across applications from discovery to the clinic.
We are proud to join forces with Replicate Bioscience to leverage our lipid nanoparticle library to accelerate the creation, scale-up, and delivery of up to 15 self-replicating RNA (srRNA) therapies. Optimization of the ionizable lipids and LNP delivery technology will maximize the srRNA vector performance, enabling Replicate Bioscience to target new diseases and develop novel drug candidates.
In collaboration with Nobel Laureate Sir Michael Houghton at Aurora Vaccines, a spin-off company from the University of Alberta, Precision NanoSystems shares its expertise and lipid nanoparticle portfolio to help bring Aurora's RNA-LNP vaccine candidate for the prevention of Hepatitis C virus (HCV) infection to a Phase I clinical trial.
We are engaged with 90% of established mRNA delivery genomic developers and look to establish strategic partnerships to enable and accelerate development of nanomedicines from discovery to commercial scale manufacturing. Our team has expertise ranging from collaborations for small-scale rare disease applications with unmet therapeutic needs to robust clinical applications with global implications.
Access ready-to-use ionizable lipid mixes or custom LNP formulations to progress lead candidates quickly through preclinical stages and license those same formulations in clinical development, accelerating transitions from discovery to the clinic.
Off-the-shelf lipid nanoparticle reagent kits for broad and targeted applications, leveraging Precision NanoSystems’ LNP formulation expertise, to quickly validate and progress lead candidates through preclinical drug development. For research use only.
Portfolio includes lipid excipients and lipid nanoparticle formulations that can be optimized and licensed through clinical stages to commercialization, helping establish targeted and scalable drug candidates quickly across applications.
Accessible
Ready-to-use kits with lipid mixes for optimized applications. Quickly and easily validate drug candidates without being a LNP formulation expert.
Licensable for Clinical Evaluation
Accelerate drug development using ionizable lipid mixes that can validate preclinical candidates and be licensed for clinical trials and commercial manufacturing.
Reliable
Robust supply chain for ionizable cationic lipids and other excipients, with proven stability and long shelf-life for consistent lipid nanoparticle formulations.
High Quality
Trusted Expertise
Leverage our trusted and proven team for ionizable lipid selection and to customize fit-for-purpose lipid compositions, building our expertise into your drug product.
Nanomedicines represent the next paradigm in drug innovation with lipid-based nanoparticles offering revolutionary new treatment modalities including saRNA and mRNA-LNP vaccines, gene therapy and cell therapy based on LNP delivery technology.
All off-the-shelf ionizable lipid formulations are intended for research use only and not for in-human use. After appropriate efficacy and safety evaluations in preclinical settings, ionizable lipids and related compositions can be licensed from Precision NanoSystems for further evaluation in clinical trials.
Partner with Precision NanoSystems to access our lipid nanoparticle portfolio and optimize fit-for-purpose LNP formulations to establish and accelerate clinically relevant, scalable drug candidates that easily transition to full-scale commercial manufacturing.
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