[Skip to Content](https://www.sigmaaldrich.com#main-content) [![MilliporeSigma](https://www.sigmaaldrich.com/static/logos/purple/millipore_sigma.svg)](https://www.sigmaaldrich.com/US/en) Products Cart0 USEN Products ProductsApplicationsServicesResourcesSupport [Login / Register](https://www.sigmaaldrich.com/oidc-sign-in) [Order Lookup](https://www.sigmaaldrich.com/US/en/order-lookup) [Quick Order](https://www.sigmaaldrich.com/US/en/quick-order) Cart0 # Custom GMP-Grade Oligos If you commercialize Molecular Diagnostics (MDx), create Laboratory Developed Tests (LDTs), or conduct preclinical research, then your final kit, assay, or modality must have an extraordinary level of quality to comply with strict regulatory or study standards. In the case of oligonucleotide raw materials available with custom specifications, the only option you should consider is Custom GMP-Grade Oligos. __Section Overview__ - [The suite](https://www.sigmaaldrich.com#suite) - [Key considerations](https://www.sigmaaldrich.com#considerations) - [Forming a partnership](https://www.sigmaaldrich.com#partnership) - [The process / visit site, meet team and conduct audit](https://www.sigmaaldrich.com#process) - [Our capabilities](https://www.sigmaaldrich.com#capabilities) - [Custom DNA oligos](https://www.sigmaaldrich.com#oligos) - [Custom qPCR probes](https://www.sigmaaldrich.com#probes) - [Next-gen sequencing oligos](https://www.sigmaaldrich.com#sequencing) - [Quality control](https://www.sigmaaldrich.com#quality) - [Related products](https://www.sigmaaldrich.com#products) Here you can learn about our GMP-Grade Oligo manufacturing capabilities as well as request a [consultation](https://www.sigmaaldrich.com/US/en/campaigns/lead-generation/custom-cgmp-oligos-request-a-consulatation) to determine which of our various products best fit your needs. ## [](https://www.sigmaaldrich.com)The suite The foundation of Custom GMP-Grade Oligos is our suite with three laboratories: Synthesis, Purification, and Quality Control. The following applies: - Filled in classified cleanroom ISO 14644-1:2015 Class 8 - Site maintains ISO 13485 Quality Management System certificate Benefits of oligos made under these quality and manufacturing systems include: - Controlled and documented processes - Extensive materials traceability - Batch-to-batch consistency - Reproducible results - Bulk amounts Manufacturing oligos in this suite maximizes risk mitigation by minimizing the probability of contamination, mix-ups, deviations, failures, and other errors, which in turn ensure that the oligo products meet the stringent requirements of MDx, LDTs, and preclinical research. ## [](https://www.sigmaaldrich.com)Key considerations When selecting a vendor, at a minimum, it is crucial to ensure that any GMP operation provides the following: - __Quality__ – performance of the oligo is the backbone of your kit, assay, or preclinical study. Using superior quality raw materials helps ensure that there will be no lost business or useless study data. - __Documentation__ – you need evidence of the required quality checks. A Certificate of Analysis (CoA) is one critical piece of evidence. Comprehensive manufacturing records are also significant in that they allow traceability for audits and proof of adherence to your quality requirements. - __Turnaround time__ – receiving your order as quickly as possible is necessary to keep your own operations according to plan. Our streamlined operations ensures that your oligos are manufactured and delivered as quickly as possible. - __Manufacturing capacity__ – without the ability to begin producing your order quickly, it is impossible to ensure that oligos are delivered quickly. As a new GMP vendor, we currently have capacity for challenging projects. - __Scale-up capability__ – your kit or assay is or will be successful or you need larger quantities of raw materials for your preclinical study. We have the ability to scale with you, whether from R&D to growth beyond commercialization or the need for ever larger studies. - __Supply chain support__ – you will want updates or may face challenges. We have customer and technical service teams that can assist you. If you are a smaller operation, you may need regulatory assistance. Our global team may be able to assist. Even if your current vendor ably meets these requirements, consider qualifying a secondary supplier. The pandemic demonstrated that regular business may be pushed aside during emergencies. ## [](https://www.sigmaaldrich.com)Forming a partnership As part of our [Commercial Oligos](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/genomics/pcr/iso-oligos) offering, we believe forming partnerships with customers is important to foster successful Custom GMP-Grade Oligos manufacturing campaigns. ## [](https://www.sigmaaldrich.com)The process / visit site, meet team and conduct audit This process is a suggested guide and not a requirement. For example, while most customers require non-disclosure agreements and request to conduct site audits, if you do not, then we will skip these steps and accelerate the process. - Visit our manufacturing facility to gather on-site information and meet with stakeholders. Additionally, if you require it, conduct an audit to ensure our ISO 13485-certified quality management standards are met. ![Sign non-disclosure: This ensures the confidentiality of sensitive information related to the project.](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/forms/custom-cgmp-oligos-sign.jpg) ### Sign non-disclosure This ensures the confidentiality of sensitive information related to the project. ![Assign project manager: This person is the primary point of contact and is responsible for coordinating the team's activities, managing timelines, and ensuring successful project execution.](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/forms/custom-cgmp-oligos-manager.jpg) ### Assign project manager This person is the primary point of contact and is responsible for coordinating the team's activities, managing timelines, and ensuring successful project execution. ![Assess your specifications: The project team carefully evaluates your requirements. They analyze the technical and practical aspects to ensure a thorough understanding of your needs.](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/forms/custom-cgmp-oligos-access.jpg) ### Assess your specifications The project team carefully evaluates your requirements. They analyze the technical and practical aspects to ensure a thorough understanding of your needs. ![Visit site, meet team & conduct audit: Visit our manufacturing facility to gather on-site information and meet with stakeholders. Additionally, if you require it, conduct an audit to ensure required quality assurance standards are met](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/forms/custom-cgmp-oligos-team.jpg) ### Visit site, meet team and conduct audit Visit our manufacturing facility to gather on-site information and meet with stakeholders. Additionally, if you require it, conduct an audit to ensure quality assurance required standards are met. ![Commence development & manufacturing: This stage involves doing all that is necessary to create the finished oligos according to the agreed specifications.](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/forms/custom-cgmp-oligos-manufacture.jpg) ### Commence development and manufacturing This stage involves doing all that is necessary to create the finished oligos according to the agreed specifications. ![Deliver as quickly as possible: Deliver the oligos in a timely fashion to help you meet your business objectives.](https://www.sigmaaldrich.com/content/dam/cms-commons/sigmaaldrich/marketing/global/images/forms/custom-cgmp-oligos-deliver.jpg) ### Deliver as quickly as possible Deliver the oligos in a timely fashion to help you meet your business objectives. * * * For a more in-depth view of this process, please see the [Project Expertise](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/genomics/pcr/iso-oligos) section of our [Commercial Oligos](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/genomics/pcr/iso-oligos) offering. Regardless of whether you work in R&D, process development, manufacturing, or procurement, our flexibility will meet the requirements of your specific role.[](https://www.sigmaaldrich.com) ## [](https://www.sigmaaldrich.com)Our capabilities As part of our [Commercial Oligos](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/genomics/pcr/iso-oligos) offering, our Custom GMP-Grade Oligos come with consistency and the highest quality. Whether you want to commercialize or develop an assay around qPCR, isothermal amplification, NGS, or other technology, our products strike the right balance between breadth and depth. ## [](https://www.sigmaaldrich.com)Custom DNA Oligos Basic PCR primers, SYBR® Green Primers, isothermal amplification primers, sequencing primers and more. __Specifications__ Amountsµg to multi-g PurificationsDesalt and HPLC Sequence Lengths7 – 100 bases ModificationsMost commercially available Formats - Pooling and aliquoting - Dry or in solution - Tubes ## [](https://www.sigmaaldrich.com)Custom qPCR probes Dual-Labeled Probes, Molecular Beacons and LightCycler® Probes. __Specifications__ Amounts µg to multi-g Purifications HPLC Sequence Lengths  7 – 50 bases Modifications - All common reporters - BHQ™ (Black Hole Quencher™) - MGB (Minor Groove Binder):EDQ (Eclipse Dark Quencher) - Locked Nucleic Acid Formats - Pooling and aliquoting - Dry or in solution - Tubes ## [](https://www.sigmaaldrich.com)Next-gen sequencing Oligos Custom next-generation sequencing adapters. __Specifications__ Amounts g to multi-g Purifications NGSO-Gold (proprietary): <0.25% cross contamination Sequence Lengths  10 – 80 bases Modifications - 5´-Phosphate - Phosphorothioate - 5-Me-dC Formats - Pooling and aliquoting - Dry or in solution - Tubes ## [](https://www.sigmaaldrich.com)Quality control Numerous quality checks are built into the manufacturing process. Those outlined here are for final products. Standard quality controls: - Sequence identity verification by mass spectrometry - Quantification by UV spectroscopy - Appearance check by inspection Optional quality controls: - Purity verification by analytical HPLC - DNase/RNase measurement - Endotoxin testing Depending on the technology, functional testing of your products in the final application may also be feasible. ## Related products Sorry, an unexpected error has occurred Response not successful: Received status code 500 __Related articles__ - [Scalable, High-Quality Custom Oligonucleotides for Commercial PCR, qPCR & NGS](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/genomics/pcr/iso-oligos) - [Custom Next-Gen Sequencing Oligos](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/genomics/next-gen-sequencing/custom-next-gen-sequencing-oligos) __Related product categories__ - [Custom DNA Oligos & qPCR Probes](https://www.sigmaaldrich.com/US/en/products/molecular-biology-and-functional-genomics/oligos-and-qpcr-probes/custom-predesigned-dna-oligos-and-qpcr-probes) - [Custom & Predesigned RNA Oligos, siRNA Duplexes and Controls](https://www.sigmaaldrich.com/US/en/products/molecular-biology-and-functional-genomics/oligos-and-qpcr-probes/custom-predesigned-rna-oligos-sirna-duplexes-controls) Top __Sign In To Continue__ To continue reading please sign in or create an account. 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