We offer custom DNA Primers, qPCR Probes, and Next-Gen Sequencing Oligos for Life Science Research Tools, Molecular Diagnostics, and Laboratory Developed Tests. We can also perform component or complete kit manufacturing, including custom formulations, packaging, and private labeling. Learn about our manufacturing capabilities or request a consultation to determine which type of product best fits your needs. Watch the video and then read on to learn the details.
At the foundation of our manufacturing processes is a robust Quality Management System (QMS), which drives compliance to our following Quality Registrations:
This quality culture is integrated into all aspects of our business. Key components of our QMS include:
Each component drives quality assurance, and for verification, we routinely host rigorous registrar, internal, and customer audits.
From early-stage research through commercial launch, we provide project expertise to ensure your success.
We believe that accountability, predictability, responsiveness, and flexibility are the keys to project success and customer satisfaction. A project management professional will work with you from the start of the project through order fulfillment.
When your project requires innovative approaches to novel oligonucleotide constructs or formulations, our scientists are available for collaboration in developing:
Process development is a critical step in creating a robust and economical manufacturing process. To set process specifications, we:
We can develop unique methods or adopt your existing protocols to meet your specifications. Our expertise in methods transfer ensures your proven analytical procedures are integrated into our quality systems. Our multi-million dollar investment in state-of-the-art instrumentation and our experienced team of scientists are the foundation for our development and qualification process.
We have the personnel, infrastructure, equipment, and facilities to handle all of your manufacturing requirements.
Our robust manufacturing processes are designed with our customers in mind. Our flexibility in manufacturing results from our technical expertise and core manufacturing capabilities, including:
We understand that consistency is critical to manufacturing success. Our engineers design and maintain proprietary synthesis platforms, processing equipment and facilities. Instruments are qualified and an extensive preventive and predictive maintenance program ensures optimal performance. Utilizing our in-process controls and LIMS to capture information, process adjustments can be made in real time. Our manufacturing expertise makes us the partner of choice for designing and creating solutions for all your production needs.
We can formulate the most complex components with precision and accuracy. We have the ability to:
Our commitment to our partners is evident in all aspects of our business. We routinely tailor programs to meet customer requirements including:
Whereas our research offering comes with breadth and speed, our commercial capabilities come with depth and consistency. Both product portfolios deliver high-quality oligonucleotides.
Basic PCR primers, SYBR Green Primers, isothermal amplification primers, sequencing primers, and more.
Dual-Labeled Probes for the 5’ nuclease assay.
iScale Oligos DNA are milligram and gram quantities of custom DNA oligonucleotides for commercial projects that require larger amounts of material.
Custom LAMP Primers are manufactured using proprietary purification adjustments so primers performance optimally in loop-mediated isothermal amplification assays.
Next-Gen Sequencing Oligos (NGSO) is custom universal and index adapter sequences manufactured to produce low levels of cross contamination.
Our ability to guarantee performance is directly related to our comprehensive understanding of oligonucleotide chemistry and synthesis platforms, our analytical systems, and our experience in methods development.
Quality control is integrated into the entire manufacturing process. Key checkpoints of quality control include:
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