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cGMP & Research‑Grade DNA/RNA — Milligrams to 100+ Grams.

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Rapid. Reliable. Secure

Large Scale Oligonucleotide Synthesis

Scale with confidence. We manufacture high‑purity, custom oligonucleotides with advanced modifications, rigorous HPLC/PAGE purification, and full QC documentation—accelerating programs from discovery to clinic.

ISO 9001: 2105 ISO 13485: 2016 GLP / cGMP Aligned Fast Turnaround
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Flexible Scale‑Up

Research‑grade to cGMP with consistent chemistry and documentation.

  • mg to 100+ g lots (DNA/RNA)
  • Single, Duplex Triplex DNA, RNA oligomer
  • Batch‑to‑batch reproducibility

*Sequence‑dependent capability.

Advanced Modifications

Chemistries for stability, delivery, and function.

  • Backbone: PS, PN, Methylphophonate
  • Sugar: 2′‑OMe, 2′‑F, LNA/BNA, 2'-MOE, cEt, FANAcEt
  • Conjugates: GalNAc, lipid, PEG, dyes, biotin
  • Formultion: Nanoparticle LNP formulation

Rigorous QC & Documentation

Regulatory‑ready data packages.

  • HPLC or PAGE purification
  • ESI‑MS confirmation; UV quant
  • CoA, traceability, stability data
  • Custom regulatory Report

Manufacturing Capabilities

At Bio-Synthesis, our manufacturing platform is designed to support projects ranging from milligrams to 100+ grams of DNA and RNA oligonucleotides. We combine high-throughput instrumentation, diverse chemistry portfolios, and GMP-aligned workflows to ensure consistent quality at every scale.

Category Options Typical Scale Purification QC Package
DNA Oligos Standard, long/Ultramer, primers/adapters, barcoded mg → 100+ g Desalt, HPLC, dual HPLC, diafiltration ESI-MS or LC-MS, duplex ratio, optional endotoxin, bioburden, sodium content, MEV-UV assay, residual chemical analysis and more..
RNA Oligos 2′‑OMe/2′‑F, capped ends, duplexes/siRNA mg → multi‑gram Desalt, HPLC, dual HPLC, diafiltration ESI-MS or LC-MS, duplex ratio, optional endotoxin, bioburden, sodium content, MEV-UV assay, residual chemical analysis and more..
Therapeutic-Grade ASO/siRNA Gapmers, splice modulators, conjugated siRNA 100 mg → 50+ g HPLC (RP/ion‑pair/AX) Full CoA, impurities, ID/assay, moisture
Conjugates & Specialty Oligos GalNAc, lipid, PEG, dyes, biotin; peptide/antibody coupling mg → multi‑gram Affinity/RP HPLC, desalting Conjugation ratio, free linker/dye, residuals

Optional tests: endotoxin, bioburden, residual solvent, heavy metals, and custom methods on request.

What Sets Us Apart

  • Flexibility — scalable from discovery batches to regulated production.
  • Breadth — supports backbone chemistries (PS, PN, boranophosphate, methylphosphonate), sugar modifications (2′-OMe, 2′-F, LNA/BNA, cEt), and custom conjugations.
  • Purification Excellence — HPLC, PAGE, dual and diafiltration workflows ensure high-purity oligos for sensitive applications.
  • Regulatory Alignment — ISO 9001:2015, ISO 13485:2016, GLP/GMP practices with full traceability and CoA.
  • Customization — OEM/private-label supply, formulation services, and long-term supply agreements.
Therapeutics
ASO, siRNA & Gapmers
QC

Stability‑enhanced designs, RNase H‑competent backbones, targeted delivery (GalNAc/lipid).

Diagnostics
qPCR & NGS

Custom probes (FRET/TaqMan®/molecular beacons), indexed primers, adapters, UDI libraries.

Synthetic Biology
Genome & Editing

CRISPR guides, capture probes, structural/biophysical oligos for advanced research.

Process, Quality & Compliance

  • Design Support: Sequence assessment, modification strategy, scale feasibility.
  • Synthesis: Optimized phosphoramidite chemistry
  • Purification: HPLC/PAGE and diafiltration, client designated purification options and purity specifications.
  • Formulation: oligo pools, assays, aliquoting and duplex, triplex formation.
  • QC & Release: ESI‑MS confirmation, purity/assay, moisture; microbiological testing as requested.
  • Documentation: GMP‑aligned batch records, CoA, full traceability.
  • Stability & Storage: Real‑time/accelerated studies; packaging configured for cold chain.
procee-quality-compliance

Optional Add-On Services

Custom Formulation & Packaging

Buffers (TE/PBS/custom), aliquoting, specific concentrations, tubes or plates, OEM labels/barcodes.

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Custom Quality Control

LC-MS, CE, extended HPLC traces, endotoxin/bioburden, water content, residual chemicals, stability program.

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Regulatory & OEM

RUO → GLP → cGMP pathways, document packages, tech transfer, sequence masking/private-label OEM.

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Need something not listed?

We routinely implement bespoke chemistries and conjugations for DNA/RNA oligonucleotides.

Get in Touch

FAQ

What scales do you support for DNA and RNA oligos?
DNA: mg to 100+ g. RNA: mg to multi-gram (sequence-dependent). Pilot scales help de-risk tech transfer.
Which modifications and conjugations are available?
Backbone (PS, PN), sugar (2′-OMe, 2′-F, LNA/BNA, cEt), and conjugations (GalNAc, lipid, PEG, dyes, biotin). Peptide/antibody coupling supported.
What purification and QC options do you offer?
Desalting, HPLC (RP/ion-pair/AX), PAGE, diafiltration. QC includes mass confirmation, purity, UV/OD260; optional endotoxin/bioburden, residual solvents, elemental impurities.
Can you supply GMP oligos for clinical programs?
Yes—aligned to ISO 9001/13485, GLP, and GMP practices with full documentation and regulatory support.
What is typical turnaround time?
Lead times vary by length, chemistry, and purification. Expedited options and staggered deliveries are available.

Contact Us

Email: info@biosyn.com • Phone: +1 (972) 420‑8505


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Why Choose BioSynthesis

Trusted by biotech leaders worldwide for over 45 years of delivering high quality, fast and scalable synthetic biology solutions.

Greetings Researchers,

Please be advised that any information, guidelines, writeups, and oral/video/graphic content on our website are intended solely as general guidelines.
It is the researcher's sole responsibility to conduct thorough research on the designs of the products intended for their experiments before submitting
their designs to Biosynthesis for review of production feasibility.
Thank you for your understanding.

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