Lipid cGMP Manufacturing

The team from BOC Sciences has extensive experience in lipid production and an in-depth knowledge of the specific requirements of pharmaceutical, cosmetic and research applications. We offer the production of a wide variety of lipid compounds including phospholipids, glycolipids, sphingolipids and fatty acids, among others. Our state-of-the-art facility and strict adherence to cGMP guidelines ensure our customers receive lipids of the highest purity and quality. We perform thorough quality control testing at every stage of the manufacturing process to guarantee the integrity and consistency of our products.

Function of Lipids

Lipids perform a number of crucial roles in the creation of pharmaceuticals, including improving the solubility, stability, and bioavailability of drugs. For instance, Lipids can be functionalized or altered to target particular tissues, cells, or receptors in a targeted manner. This enhances therapeutic efficacy by allowing medications to be delivered selectively to particular areas while reducing off-target effects. Lipids can also be utilized to generate formulations for a variety of dosage forms, such as oral, topical, and parenteral formulations. Lipid-based formulations can enhance patient compliance, medication administration, and stability.

Lipids Synthesis Technologies

Natural lipids can currently be taken out of plants, animals, and microbes. Enzymatic extraction, supercritical fluid extraction, and solvent extraction are popular extraction techniques. In these processes, raw materials are broken down to liberate lipids and separate them from other components. Creating lipids by microbial fermentation is another technique. Microorganisms such as yeast, bacteria and algae secrete lipids when stimulated with specific nutrients. Lipids can also be chemically synthesized using various chemical reactions. This method can produce specific lipid molecules with desired properties. However, chemical synthesis is generally more expensive and less sustainable than extraction or fermentation methods. Additionally, genes responsible for lipid synthesis can be inserted into plants or microorganisms to enhance their lipid production capacity, an approach that allows for the generation of lipid variants that may not occur naturally.

Our Lipid Manufacturing Capabilities

Lipid Applications

• Lipid nanoparticles: gene therapy, immunotherapy, and drug delivery
• Gene therapy and transfection vectors: mRNA, siRNA or DNA
• Immunotherapy: CAR-T cells, immune regulation
• Cosmetic lipids: moisturize, protect, and reduce inflammation
• Lipopolymers: hybrid nanoparticles

Manufacturing Facilities and Instruments

• Organic synthesis laboratories: equipped with more than 100 reactors of various sizes ranging from 20L to 2,000L, including glass reactors, stainless steel reactors, and high-pressure reactors.
• Analytical instruments: 2 preparation and purification laboratories are equipped with state-of-the-art HPLC, GC, NMR spectrometers, mass spectrometers and infrared spectrometers.
• Pilot plant facilities: 7 pilot lines support method design, development, qualification, validation and optimization of various biochemicals.
• cGMP-compliant facilities: cGMP-compliant manufacturing facility of over 4,000 square meters supports formulation development and manufacturing and various commercializations.

Our cGMP Analytical Capabilities

BOC Sciences offers comprehensive lipid analysis services that include the identification and quantification of various lipid classes such as phospholipids, glycolipids, and neutral lipids. Our team of experienced lipid analysis scientists has the knowledge and expertise to accurately analyze and interpret lipid data. In addition, we can develop custom analytical methods and protocols to meet client-specific research needs, ensuring analysis is optimized for specific lipid samples and research objectives. BOC Sciences has always strived to provide accurate, timely results and strives to provide a fast turnaround time for lipid analysis projects.

The mission of BOC Sciences is to consistently provide high quality lipid products. We are constantly working to update our synthesis laboratory equipment, analytical tools and chromatographic purification systems. And continue to learn and innovate lipid synthesis, manufacturing and analysis technologies, aiming to provide global customers with high-quality and high-standard cGMP manufacturing services that meet CMC and regulatory requirements. In addition, we also provide a one-stop solution for PEG. Our PEG products include different molecular weights, functional groups and chemical modifications such as PEG copolymers, PEG linkers, PEG conjugates and PEGylation reagents. Our PEG cGMP manufacturing services include process development, optimization, scale-up and production. We have the expertise and capabilities to handle both small-scale and large-scale manufacturing, ensuring consistent quality and timely delivery.