• Oligonucleotide Drug Research

    Hengkang Pharma provide 90% and 95% or customer purity for all below oligonucleotide, All oliconucleotide only for research and development.

    Hengkang Pharma provide siRNA, ASO, etc custom synthesis service.

 
  • Bepirovirsen CAS 1403787-62-1
    Bepirovirsen CAS 1403787-62-1, is an antisense oligonucleotide developed by GSK and Ionis Pharmaceuticals Inc. It is a viral protein inhibitor. Currently, the highest development stage of the drug...
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  • Inclisiran Sodium CAS 1639324-58-5
    Inclisiran sodium CAS 1639324-58-5, is a first-in-class siRNA developed by Alnylam Pharmaceuticals Inc. It is a PCSK9 inhibitor. Currently, the highest development stage of this drug is approval...
    view more
 

Product Overview

 

 

Oligonucleotide products are custom-synthesized single- or double-stranded DNA and RNA molecules manufactured for molecular diagnostics, research reagents, and therapeutic development. Production scales range from nanomole research quantities to millimole commercial volumes, supporting applications from standard PCR assays to clinical-stage therapeutic manufacturing.
Each oligonucleotide order undergoes automated synthesis via phosphoramidite chemistry, followed by dedicated downstream purification and analytical verification (MS and HPLC/CE) to ensure structural integrity and sequence fidelity.

 

Key Characteristics & Product Features

 

Synthesis Scale: 10 nmol to 10 mmol production capacity per batch, accommodating early discovery screening through commercial-scale bulk manufacturing.
Backbone & End Modifications:
Standard Phosphodiester and stabilized Phosphorothioate (PS) backbones.
5' / 3' modifications including Biotin, Aminolink, Thiol modifiers, Cholesterol, and standard/custom fluorescent labels.
Advanced structural modifications: Locked Nucleic Acids (LNA), 2'-O-Methyl (2'-OMe), and 2'-Fluoro (2'-F) modifications.
Purification Options: Desalting, Cartridge (RPC), Polyacrylamide Gel Electrophoresis (PAGE), Reverse Phase HPLC (RP-HPLC), and Ion-Exchange HPLC (IE-HPLC) achieving over 98% target purity.
Traceability: Every batch includes raw material lot tracking, coupling efficiency logs, and automated synthesis run data.

Manufacturing Capabilities
 

Production operations utilize high-throughput automated DNA/RNA synthesizers housed in controlled cleanroom environments to minimize cross-contamination and particulate generation.

Equipment Infrastructure:

Multi-scale solid-phase synthesizers capable of parallel synthesis, automated cleavage and deprotection systems, and high-capacity preparative HPLC purification skids.

Reagent Control:

Strictly audited phosphoramidite monomers, activators, and solvents with controlled moisture content (less than 10 ppm) to maintain high coupling efficiency (over 99%).

Scale-Up Transition:

Seamless technology transfer protocols from small-scale discovery plates to large-scale columns, maintaining consistent synthesis parameters and impurity profiles.

 

Quality Control & Analytical Support
 

Analytical validation is performed on every synthesized lot prior to release. Testing protocols are executed according to validated standard operating procedures (SOPs).

Identity & Purity Verification:

Mass Spectrometry (ESI-MS / MALDI-TOF): Confirms molecular weight and exact sequence mass against theoretical values.
Analytical HPLC / CE: Quantifies full-length product percentage and resolves failure sequences.

Contaminant Testing:

Endotoxin Testing: Limulus Amebocyte Lysate (LAL) assay yielding less than 0.005 EU/mg for diagnostic and in vivo-grade products.
Residual Solvent & Bioburden Analysis: Performed on bulk and therapeutic-grade intermediates.
Documentation: Certificate of Analysis (COA) containing trace spectra (HPLC/MS) and yield quantification is supplied with every shipment. Full supply chain documentation is available for technical audit support.

 

 

Technical Specifications

 

 

Parameter

Specification Range

Test Method / Standard

Sequence Length

2 to 150 bases (DNA/RNA)

Capillary Electrophoresis / PAGE

Purity Levels

Desalted (over 70%) to IE-HPLC (over 98%)

Analytical HPLC / CE

Coupling Efficiency

Average over 99.2% per step

Automated Monitor / Conductivity

Yield Tolerance

Plus or minus 15% of ordered quantity

OD260 UV Spectrophotometry

Endotoxin Level

Less than 0.005 EU/mg (Low Endotoxin Grade)

Kinetic-Turbidimetric LAL Assay

Shipping Format

Lyophilized (standard) or Liquid (nuclease-free water/TE buffer)

Gravimetric Quantification

 

 

FAQ

 

 

Q: How do you prevent sequence errors and truncation during long oligonucleotide synthesis?

A: We maintain coupling efficiency above 99.2% per cycle through optimized activator formulations and rigorous moisture control (less than 10 ppm) in anhydrous acetonitrile. Capping steps are executed after each coupling cycle to permanently terminate unreacted failure sequences, and preparative HPLC or PAGE purifications isolate full-length products from truncated failure sequences.

Q: What analytical data is provided with each custom oligonucleotide batch?

A: Every shipment includes a detailed Certificate of Analysis (COA) reporting exact yield (nmol/mg), molecular weight, measured purity percentage, and analytical test results. Original raw data spectra, including Mass Spectrometry (MS) and Analytical HPLC or Capillary Electrophoresis (CE) traces, are included for verification.

Q: Can you scale up production from research scale to bulk commercial supply?

A: Yes. Our facility operates multi-scale synthesis platforms, allowing direct process transfer from 96-well discovery plates to multi-millimole synthesis columns. We support long-term supply agreements with locked-in raw material sourcing, validated scale-up parameters, and dedicated batch reservation for commercial diagnostic and therapeutic programs.

Q: How do you handle intellectual property (IP) and sequence confidentiality?

A: All client sequences, project descriptions, and proprietary modifications are protected under strict Non-Disclosure Agreements (NDAs). Our IT infrastructure utilizes segregated, secure databases with restricted access protocols, ensuring complete isolation of customer intellectual property throughout the quotation, synthesis, and delivery lifecycle.

Q: What are the typical lead times for standard vs. modified oligonucleotides?

A: Standard unmodified DNA oligonucleotides (desalted/purified) are synthesized, analyzed, and shipped within 3 to 5 business days. Complex modified oligonucleotides (e.g., dual-labeled probes, LNA, or custom fluorescent conjugates) typically require 7 to 10 business days. Bulk commercial orders follow a customized project timeline defined during technical review.

Q: What packaging and storage conditions are recommended upon receipt?

A: Oligonucleotides are shipped lyophilized (dry pellet) at ambient temperature to ensure stability during transit. Upon receipt, lyophilized products should be stored at -20°C or -80°C, where they remain stable for over 12 months. Once reconstituted in nuclease-free water or TE buffer, solutions should be stored in single-use aliquots at -20°C to avoid freeze-thaw degradation.

Zhejiang Hengkang Pharmaceutical Co., Ltd. is well-known as one of the leading oligonucleotide manufacturers and suppliers in China. With a professional production team, we are able to meet the needs of the majority of our customers. Please feel free to wholesale bulk high quality oligonucleotide from our factory.

1639324-58-5, Bepirovirsen CAS 1403787 62 1, CAS 1403787 62 1
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