Quality Control Premium Oligonucleotide Synthesis |
Gene Link maintains an integrated quality management system independently assessed against the industry’s leading standards for the production of complex DNA and RNA oligonucleotide modifications.
Gene Link is certified to ISO 9001:2015. Issued by International Auditors Inc. (accredited by the North American Accreditation Bureau, #1803), this certification confirms that our processes meet internationally recognized standards for quality management and continual improvement.
Certificate No. IAI-QMS-20091610
Gene Link is certified to ISO 13485:2016, the international quality-management standard for medical devices. Issued by International Auditors Inc. (NAB accreditation #1803), it reflects our commitment to the rigorous quality and regulatory controls that support medical, diagnostic, and forensic applications of our products.
Certificate No. IAI-MD-20101626
Gene Link’s manufacturing operations have been independently assessed by ISOP Solutions Inc. and found compliant with current Good Manufacturing Practices (cGMP) for pharmaceuticals — underscoring our dedication to the controlled processes, documentation, and quality systems required for pharmaceutical-grade production.
Compliance No. ISOP-GMP-20101627
IntroductionGene Link Oligo Synthesis Division is not an "oligo factory". Order Gene Link Oligos for demanding applications and consistent results. Gene Link oligos will not fail due to quality reasons. Each oligo is meticulously monitored during synthesis for coupling efficiency and after processing by polyacrylamide gel electrophoresis. A Gel picture is supplied with each oligo.
All Gene Link synthesized custom oligonucleotides are supplied desalted, lyophilized and ready to use after reconstruction. The oligonucleotides are synthesized on state of the art computer controlled DNA synthesizers. The "crude" desalted ethanol precipitated product is suitable for most PCR** amplification, Short Tandem Repeat Polymorphism (STRP) repeat analysis for gene mapping and sequencing experiments. |
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Gene Link oligos are for demanding applications and consistent results. We believe that investigators who value time and have no room for an experiment to fail due to oligo quality should consider Gene Link.
Our numerous quality control steps for each oligo assure confidence. We maintain an absolute standard of coupling efficiency threshold of greater than 99.5% for all oligos by using the best reagents. Trityl monitoring coupling efficiency of each base added during synthesis with programmed ‘halt’ to seek user intervention if it falls below the threshold. This is not much evident when comparing short oligos but is a requirement for long oligos. Ask our competitors how often they synthesize 200 to 250 mer. Please see the coupling efficiency table and graph down below. Gene Link specializes in long oligos. Our description of long oligos is 180mer to 250mer. You are invited to compare.
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Actual Trityl Coupling Efficiency of a 210 mer |
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Each oligo is run side by side on a polyacrylamide gel to visually assess quality. A real gel picture is included as part of the oligo report.
| Crude Oligo Gel | Gel Purified Oligo Gel |
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Crude Oligo Gel Electrophoresis Polyacrylamide gel electrophoresis of crude oligos. Approximately 8 µg of crude unpurified oligo were loaded to show the truncated failure sequences if any. Lanes 1 ‑ 7: Oligo sizes, 51, 64, 48, 42, 25, 18 and 20.Results: A major single band represents high purity of the crude oligonucleotide. The above gel picture shows the quality of Gene Link oligos. All Gene Link oligos are provided with an actual gel picture. |
Gel Purified Oligo Gel Electrophoresis Polyacrylamide gel electrophoresis of crude and gel purified oligos in adjacent lanes. Lanes 1 & 2: 78 mer; lanes 3 & 4: 96 mer; lanes 5 & 6: 161 mer; lanes 7 & 8: 42 mer.Results: At Gene Link we recommend gel purification of all long oligos and oligos used in cloning applications. Gel purification is the “gold standard” method of purification as the denaturing polyacrylamide gel resolution approaches single base and the major band is clearly visible to be purified. |
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Oligo Coupling Efficiency and Expected Yield |
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| PCR and sequencing reactions are very robust and can tolerate up to 50% failure/truncated sequence oligos. However, you are clearly taking a chance by using long oligos synthesized at anything below 99.5% coupling efficiency. |