Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester

Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester is an ionizable amino lipid that has been specifically engineered for the formation of lipid nanoparticles (LNPs) for mRNA‑based vaccine delivery. As a functional excipient, Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester enables efficient encapsulation of mRNA molecules, protects them from premature enzymatic degradation, and facilitates cytosolic release through endosomal membrane destabilization. Structurally, Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester is recognized as SM-102 and is a critical component of next‑generation nucleic acid delivery platforms. In vaccine formulations, Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester is combined with helper lipids (DSPC, cholesterol, and PEG‑lipid) to form stable LNPs that demonstrate favorable biodistribution and immunogenicity profiles.

Product Parameters

Why Cosperpharm?

Cosperpharm provides Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester (SM-102) to pharmaceutical companies, biotech firms, and research institutions developing mRNA‑based therapeutics and vaccines. Our GMP‑like manufacturing guidelines ensure batch‑to‑batch consistency and high purity essential for LNP formulation. Comprehensive analytical release testing—including HPLC purity, ¹H NMR structural confirmation, and residual solvent analysis—accompanies each shipment. With flexible packaging from milligram‑scale R&D quantities to kilogram‑scale cGMP supply, we support your program from discovery through commercial launch. Full documentation packages, including Certificates of Analysis and stability summaries, are available to facilitate regulatory submissions. Contact Cosperpharm to secure your supply of this essential ionizable lipid.

FAQ

Q1: What is SM‑102?

A: SM‑102 is the common name for Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester, an ionizable amino lipid used in the formation of lipid nanoparticles (LNPs) for mRNA delivery. It is the key ionizable lipid component in the Moderna COVID‑19 mRNA vaccine (Spikevax®).

Q2: How does SM‑102 differ from ALC-0315?

A: SM‑102 and ALC‑0315 are both ionizable lipids used in mRNA vaccines, but they have different tail structures. SM‑102 features a branched 1‑octylnonyl ester tail and an undecyloxy chain, while ALC‑0315 has two symmetric 2‑hexyldecanoate tails. SM‑102 is used in the Moderna vaccine; ALC‑0315 is used in the Pfizer/BioNTech Comirnaty® vaccine.

Application Scenarios

1. mRNA Vaccine Manufacturing

As the key ionizable lipid component in Moderna’s Spikevax® COVID‑19 vaccine, Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester is used in commercial‑scale LNP formulations for mRNA vaccine production against infectious diseases including SARS‑CoV‑2, influenza, and RSV.

2. Personalized Cancer Vaccine Development

SM‑102‑based LNPs enable efficient delivery of neoantigen‑encoding mRNA for personalized cancer immunotherapy, facilitating tumor‑specific T‑cell responses in clinical trials.

3. CRISPR‑Cas9 Gene Editing Delivery

Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester is employed in LNPs for the delivery of CRISPR‑Cas9 ribonucleoproteins (RNPs) and mRNA‑encoded Cas9, enabling therapeutic gene editing for genetic disorders.

4. Protein Replacement Therapy

LNPs formulated with SM‑102 encapsulate mRNA encoding therapeutic proteins (e.g., factor IX for hemophilia, CFTR for cystic fibrosis) for protein replacement applications in rare genetic diseases.

5. LNP Formulation Process Development

Pharmaceutical scientists use Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester to optimize LNP manufacturing parameters including microfluidic mixing conditions, lipid molar ratios, and particle size control for mRNA encapsulation efficiency.

6. Analytical Method Development for LNPs

Reference grade SM‑102 serves as a standard for developing and validating HPLC‑CAD, LC‑MS, and other analytical methods for quantifying ionizable lipid content in LNP drug products and drug substances.

7. Quality Control Release Testing

Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester is an essential reference standard for QC release testing of SM‑102‑based LNP drug products, including identity, purity, and content uniformity assays.

8. Stability‑Indicating Studies

Used as a reference marker in forced degradation studies of SM‑102‑containing LNPs under thermal, oxidative, photolytic, and hydrolytic stress conditions, supporting shelf‑life determination and storage condition validation.

Contact Us

Need a reliable source of high‑purity Octanoic acid, 8-[(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino]-, 1-octylnonyl ester for your mRNA vaccine program or LNP development project? Cosperpharm delivers consistent quality, flexible volumes, and documentation that supports your regulatory path. Reach out to our team to discuss your requirements, request a quote, or arrange a technical consultation.