Oligonucleotide GMP Manufacturing

BOC Sciences specializes in the manufacture of high-quality oligonucleotides, and our flexible production model can meet all your production needs. As a company that provides high-volume oligonucleotide drugs to global customers, we have extensive expertise and unique technical advantages in oligonucleotide synthesis, modification, purification and characterization. Each oligonucleotide is synthesized in the production room by well-trained and skilled chemists. By cooperating with us, you will get an efficient, professional and low-cost one-stop solution.

Oligonucleotide Definition

Oligonucleotide refers to a short nucleotide sequence molecule (component of DNA and RNA). It has a wide range of uses in genetics, forensics and scientific research. At the same time, there are many oligonucleotides in cells that participate in various gene expression and functional regulation processes. Oligonucleotides are used as drugs to treat various diseases, mainly based on their use as basic tools for regulating gene expression in biomedical and life science research, and thus have been developed as gene-targeted therapeutic drugs for the treatment of viruses, tumors and genetic diseases. The progress of oligonucleotide drugs has led to new mechanisms for controlling gene expression, which inhibit the production of pathogenic proteins by controlling gene expression levels through drugs. Oligonucleotide drugs mainly include antisense oligonucleotides (ASO), small interfering RNA, ribozymes, deoxyribozymes, antigens, CpG oligonucleotides, transcription factor decoys and nucleic acid aptamers (Aptamers).

Antisense Oligonucleotides

At present, the most studied oligonucleotide drugs are antisense oligonucleotides. ASO is defined as a chemically synthesized oligonucleotide, usually 12-30 nucleotides in length. ASO binds to specific RNA sequences through the principle of base complementary pairing, and then regulates gene expression by degrading, breaking or occupying the targeted RNA sequence. At present, the source of ASO is still chemical synthesis. ASO-based disease treatment has a lot to do with the chemical synthesis structure design of ASO. Researchers can rationally design ASO to regulate target RNA based on the expected binding position of ASO on RNA and the function of RNA, based on the chemical structure and position requirements of different mechanisms. At the same time, some screening is required to obtain the best activity and tolerance, so as to achieve the best disease treatment effect.

Oligonucleotide Synthesis

Oligonucleotide synthesis is fundamental to many molecular biology applications, including polymerase chain reaction (PCR), gene editing, DNA sequencing, and gene therapy. Currently, oligonucleotides are primarily made using solid-phase synthesis methods, which have been developed to allow the synthesis of kilogram quantities of oligonucleotides for use as drug molecules (such as antisense oligonucleotides). BOC Sciences has launched a large-scale oligonucleotide synthesis business line for the application of oligonucleotide drugs, providing cost-effective products for scientific researchers and industrial needs. We have introduced advanced equipment such as large-scale oligonucleotide synthesizers, which can synthesize high-purity DNA/RNA oligos from grams to kilograms, including small nucleic acid raw materials (ASO, siRNA, miRNA, saRNA and Aptamer, etc.) used in pharmaceutical research and development, immune adjuvant CpG-ODN for vaccine production, filler Oligo (dT) for mRNA purification, as well as DEL primers, trimer primers and CRISPR sgRNA. Our capabilities include but are not limited to:

Oligonucleotide CDMO

With a strong focus on quality, efficiency, and innovation, BOC Sciences has become a trusted partner for oligonucleotide synthesis, modification, purification, and analysis for research, diagnostic, and therapeutic applications. Our oligonucleotide CDMO services cover a wide range of custom synthesis options, including DNA, RNA, RNA-DNA hybrids, chemically modified oligonucleotides, and conjugates with various functional groups or delivery systems. Our experienced team of scientists and chemists is committed to providing high-quality oligonucleotides with precise sequence control, excellent purity, and biological activity. From initial project consultation to final product delivery, the team works closely with customers to understand their needs, develop customized synthesis strategies, and optimize process parameters for each project.

In addition, BOC Sciences offers a comprehensive range of oligonucleotide modifications to enhance their stability, target specificity, or cellular uptake. These modifications include, but are not limited to, phosphorothioate bonds, 2'-O-methyl or 2'-O-methoxyethyl substitutions, locked nucleic acids (LNA), peptide nucleic acids (PNA), fluorescent dyes, and cholesterol or other lipid conjugates. By incorporating these modifications into the oligonucleotide sequence, BOC Sciences can tailor the properties of the molecule to meet specific research or therapeutic goals. In addition to custom synthesis and modification services, BOC Sciences also provides purification and analytical services to ensure the quality and performance of oligonucleotides. Purification methods such as HPLC, PAGE, and ion exchange chromatography are used to remove impurities and obtain high product yields. In addition, analytical techniques such as MALDI-TOF mass spectrometry and gel electrophoresis are used to accurately characterize the molecular weight, sequence, and purity of synthetic oligonucleotides.

Facilities & Equipment

Professional background covers pharmaceutical chemistry, pharmaceutical preparations, organic chemistry, analytical chemistry, bioengineering, biochemical technology, pharmacy or other related majors. Our manufacturing facility in China spans over 40,000 square feet with purpose-built manufacturing space that is flexible in scale. There is a complete set of synthesis and purification equipment in the space, which can meet the production needs of oligonucleotides from grams to kilograms. Equipped with a range of routine monitoring systems for temperature, pressure, humidity and particle counting, our cGMP suites provide comprehensive quality support. Besides that, BOC Sciences has a C-level pilot plant of 600 square meters and a D-level pilot plant of 200 square meters, as well as a C-level QC testing plant of 100 square meters that meet the requirements of cGMP, with a P2 laboratory qualification for the C-level plant of 80 square meters. There is one sterile filling and formulation production line.

Quality System

As a leading manufacturer of oligonucleotides, our world-class technical expertise can support your project from laboratory research to commercial launch. Our CDMO services provide comprehensive and customizable solutions for oligonucleotide synthesis, modification, purification and analysis, enabling customers to advance their scientific research and accelerate the development of innovative biotherapeutics and diagnostics.

• Global quality assurance and management support system (ISO 9001 and ISO 13485 certified).
• cGMP compliant and passed the US FDA inspection.
• Dedicated synthesis and purification system.
• Classified production workshop with restricted access.
• Large-scale synthesis reduces batch-to-batch variability to ensure batch stability.
• Synthesis, purification and detection equipment such as AKTA, IE-HPLC, QEplus, CE and NMR.
• High-quality raw material supply and clean and safe production process.

Why Choose BOC Sciences?

With a focus on quality, innovation and customer satisfaction, BOC Sciences is poised to become the partner of choice for oligonucleotide-based R&D projects in the biopharmaceutical industry. Our mission is to help our customers create a healthier world.

• High yield: Bulk orders can be made upon request with guaranteed fast delivery.
• Comprehensive modifications: From general modifications to fluorescent/non-fluorescent labeling and even dual and multiple labeling.
• Personalized customization: Provide a variety of customization and CDMO services.
• Flexible facility portfolio: Advanced high-throughput production equipment and manufacturing plants around the world.
• Experienced team: Scientists and staff with more than 15 years of experience in oligonucleotide synthesis and modification.
• Competitive price: Using in-house produced raw materials (phosphoramidites, reagents and solvents) combined with our automated oligonucleotide synthesis and purification system, we can provide low-cost and high-quality oligonucleotides.

BOC Sciences is committed to providing reliable and cost-effective oligonucleotide CDMO services. Whether customers need research-grade oligonucleotides for in vitro studies, diagnostic probes for molecular detection, or therapeutic candidates for preclinical development, BOC Sciences can use our expertise and infrastructure to meet a variety of project needs efficiently and on time. If you are interested in our oligonucleotide GMP manufacturing service, please contact us immediately. In addition, we also provide oligonucleotides custom development services.