Lipids Custom Development

BOC Sciences' lipid solutions can support your lipid needs from development to large-scale commercialization. As a highly specialized CDMO service provider, we focus on providing customers with customized lipid products. In addition, we can provide all the raw materials required for lipid manufacturing. Our lipid development services provide a comprehensive and customizable platform for the synthesis, modification, and derivatization of lipid molecules to meet the diverse needs of academic researchers, pharmaceutical companies, and biotechnology companies.

What is Lipids and Its Function?

Lipids are a class of hydrophobic or amphipathic compounds that are bioorganic molecules soluble in non-polar solvents. They play crucial roles in physiology, storing energy, forming the cell membrane skeleton, and participating in membrane signaling. Lipid metabolism disorders have been shown to cause many major diseases. Lipids can be divided into fatty acyls, glycerolipids, glycerophospholipids, sphingolipids, sterol lipids, pentanediol lipids, glycolipids and polyketides. The amphiphilicity of certain lipids enables them to form organized structures such as vesicles or membranes when immersed in an aqueous environment. They can be extracted from tissues of plant or animal origin using low-polarity solvents such as chloroform.

Lipids are composed of repeating units of fatty acids, which are composed of hydrogen, carbon, and oxygen. There are many types of lipids, each of which is important for various functions of the body. These include simple lipids such as fatty acids, complex lipids such as phospholipids and derived lipids such as cholesterol. Currently, lipids are widely used in drug development and drug delivery. For example, lipid nanomedicine is one of the classic drug delivery systems with good biocompatibility and biodegradability, and can effectively reduce the adverse reactions of anti-tumor and anti-infective drugs in clinical practice.

Lipid Development Services

BOC Sciences' synthesis team has extensive experience in lipid synthesis and can solve most synthesis problems. We utilize innovative technologies to offer our customers a variety of lipid structures to meet all your specific needs. BOC Sciences' lipid synthesis services cover a variety of lipid classes, including but not limited to glycerophospholipids, sphingolipids, sterols, and prenol lipids.

Lipid Synthesis Services

One of the key advantages of BOC Sciences' lipid synthesis services is the ability to produce custom lipid molecules with a high degree of structural complexity and diversity. Whether designing novel phospholipids with unique headgroup functionality or synthesizing sphingolipids with specific acyl chain compositions, BOC Sciences' expertise in lipid chemistry enables the creation of highly specialized lipid species that are not readily available from commercial sources.

Isotopically Labeled Lipids

In addition, BOC Sciences provides a series of isotope-labeled lipid synthesis options that allow researchers to incorporate stable isotopes such as deuterium, carbon-13, and nitrogen-15 into lipid molecules for metabolic tracking studies, mass spectrometry-based lipidomics, and other applications. Isotopically labeled lipids are valuable tools for studying lipid metabolism, membrane dynamics, and lipid-protein interactions. BOC Sciences' capabilities in this area provide researchers with custom-labeled lipid compounds to meet their specific research needs.

Lipid Modification and Derivatization

In addition to custom lipid synthesis, BOC Sciences offers lipid modification and derivatization services to functionalize lipid molecules with a variety of chemical groups, fluorescent probes, or affinity tags. This capability will be particularly valuable for researchers seeking to study the biological properties of specific lipid species or to develop lipid-based probes for imaging and detection purposes. By offering a comprehensive set of lipid modification options, BOC Sciences enables researchers to design and obtain custom lipid molecules with enhanced functionality for use in their experimental studies.

Examples of Synthetic Capabilities

• Fluorescent lipids
• Neutral lipids
• Portfolio lipids
• Fatty acid modified lipids
• Lipidomics
• PEGylated lipids
• Cationic lipids
• Polymerizable lipids
• Photoswitchable lipids
• Targeted lipids

Lipids Manufacturing

In addition to custom synthesis, BOC Sciences offers a variety of off-the-shelf lipids for immediate purchase. These lipids are produced using high-quality raw materials and state-of-the-art manufacturing processes to ensure purity and consistency. Our extensive product catalog includes a wide range of standard lipids such as palmitic acid, phosphatidylcholine, sphingomyelin and cholesterol, among others.

We have mastered the synthetic manufacture of complex lipids from grams to kilograms and are able to deliver them in a short period of time. Our manufacturing facilities use a quality system compliant with ICH Q7 to satisfy oversight of the entire production process. Additionally, we adhere to strict quality control measures throughout the entire manufacturing process, from raw material sourcing to final product testing, which ensures that the lipids we produce meet the highest standards of purity, potency, and safety.

Lipid Purification and Analysis

BOC Sciences' lipid synthesis services are supported by a rigorous quality control process to ensure the purity, identity and structural integrity of lipid products. We can use advanced analytical techniques such as high-resolution mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, and chromatographic methods to verify the chemical composition and structural characteristics of synthetic lipids, giving researchers confidence in the quality and reliability of the lipid products. We have well-established lipidomics research methods and are able to perform systematic analysis. Our analytical tools include:

• Thin-layer chromatography (TLC)
• Gas chromatography-mass spectrometer (GCMS)
• Electrospray ionizationmass spectrometry (ESI-MS)
• Matrix assisted laser desorption/ionization-time of flight mass spectrometry (MALDITOF-MS)
• Nuclearmagnetic resonance (NMR)

Quality Verification and Compliance

In addition to the analysis and purification of lipids, there are many critical factors in the quality attributes of lipid products that require careful consideration as they can affect the final drug product during production, storage or its clinical performance. Taking liposomes as an example, some of the critical quality attributes for the production of our lipid products include:

• Appearance: The appearance of lipid products is affected by the presence of free drug and liposome-encapsulated drug. Particle size and charge also affect the appearance of the drug product. Regulatory agencies generally require visual inspection as a release criterion.
• Drug identification: Drugs need to be identified for consistency to ensure patient safety. Incorrect administration may cause harm to the patient. Regulatory agencies generally expect to require qualification testing as a release criterion. The identification of the drug is not affected by any process parameters.
• Cholesterol identification: Cholesterol prevents liposomes from leaking in the body because it gives rigidity to the liposome membrane. Therefore, it is critical for the in vivo performance of liposomal drug products. Cholesterol identification is not affected by any process parameters.
• Phospholipid identification: Phospholipids are the basic components of lipids. Identification of phospholipids was not affected by any process parameters.
• Drug encapsulation: In some cases, free drugs can exhibit adverse/toxic effects in vivo, in which case it is important to define and detect drug encapsulation by lipid systems.
• Average particle size: The average particle size affects the circulation characteristics of liposomes.
• Content uniformity: Content uniformity may affect the dosage of a drug and thus the efficacy of the drug.
• Average pH: The pH value also affects the stability of the lipid, thus affecting the release of the drug from the liposome. Deviated pH may also cause stimulation at the injection site.
• Mean osmolality: Osmotic pressure deviations may cause irritation at the injection site. Changes in mean osmolality are considered unlikely to cause irritation.
• In vitro release: Determine the in vitro release properties of a drug product and confirm the absence of uncontrolled leakage under a range of physiological conditions. This parameter should be within acceptable standards.
• Total phosphorus: Total phosphorus is the sum of all phospholipids, which affects lipid properties and drug encapsulation efficiency.
• Residual solvent: Residual solvent may cause drug to leak from the liposomes. Free drugs can cause serious side effects.

CMC Registration Support

• We stand ready to provide valuable insights and services for your lipid molecules to enter preclinical research. With industry-leading experience, we are able to provide you with assessment and qualification solutions to help you choose the best regulatory pathway. Our team guides and oversees every process when you submit an IND application.
• When your lipid drug enters clinical trials, our experts can perform protocol writing and results analysis at all clinical stages. Once safety, proof of concept, and regulatory proofs are all established, we'll start to guide you through the NDA filing process.
• After approval, in order to ensure the smooth entry of your drug into the market, we will adhere to the "last mile" and provide you with final safety monitoring services, including post-approval research support, long-term pharmacovigilance, GMP audit support, etc.

Whether it is a custom lipid with specific structural characteristics or a standard lipid available for immediate purchase, BOC Sciences has the expertise and resources to provide customers with high-quality lipids. If you are interested in our lipids development service, please contact us immediately.