Custom Oligos for Commercial Use
We offer custom DNA Primers, qPCR Probes, and Next-Gen Sequencing Oligos for Life Science Research Tools, Molecular Diagnostics (MDx), and Laboratory Developed Tests (LDTs). 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.
Quality Assurance
At the foundation of our manufacturing processes is a robust Quality Management System (QMS), which drives compliance to our following Quality Registrations:
- ISO 9001:2015 for manufacturing research-grade oligonucleotides
- ISO 13485:2016 for manufacturing diagnostic-grade oligonucleotides
- ISO 14001:2015 for effective environmental management
This quality culture is integrated into all aspects of our business. Key components of our QMS include:
- Certificates of analysis
- Document control
- Change notification
- Vendor management
- Business agreements
- Corrective and preventive actions
Each component drives quality assurance, and for verification, we routinely host rigorous registrar, internal, and customer audits.
Project Expertise
From early-stage research through commercial launch, we provide project expertise to ensure your success.
Project Management
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.
Product Development Support
When your project requires innovative approaches to novel oligonucleotide constructs or formulations, our scientists are available for collaboration in developing:
- Conjugates and complex dye labeling
- Customized purification and analytical methods
- Optimized ready-mixes and customized PCR/amplification enzyme formulations
- Product and process optimization to maximize manufacturability
- Component or kit packaging design and private labeling
Process Development
Process development is a critical step in creating a robust and economical manufacturing process. To set process specifications, we:
- Identify critical control parameters and risks
- Develop consistent and reproducible processes
- Create specifications and manufacturing documents
- Provide small lots for stability testing, design verification, and design validation
- Manufacture the necessary pilot batches to achieve production scale
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.
Reliable Manufacturing
We have the personnel, infrastructure, equipment, and facilities to handle all of your manufacturing requirements.
Flexible Manufacturing
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:
- Flexible automation
- Range of production scales
- Stringent quality control
- Laboratory Information Management System (LIMS)
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.
Custom Formulations & Packaging
We can formulate the most complex components with precision and accuracy. We have the ability to:
- Formulate liquids and dry powders on a small to large scale
- Accommodate a variety of packaging configurations including microtiter plates, tubes and bottles
- Package a single component or an entire kit to your specifications
- Private label your product
Support Services
Our commitment to our partners is evident in all aspects of our business. We routinely tailor programs to meet customer requirements including:
- Functional testing of your product
- Regulatory compliance consulting
- Audits of any of our facilities
- Forecasting and capacity planning
- Quarterly business reviews
- Key performance indicators (KPIs)
- Inventory management services
- Global warehousing and distribution
Basic Commercial Capabilities
Whereas our research offering comes with breadth and speed, our commercial capabilities come with depth and consistency. Both product portfolios deliver high-quality oligonucleotides.
Custom DNA Oligos
Basic PCR primers, SYBR Green Primers, isothermal amplification primers, sequencing primers, and more.
Custom qPCR Probes
Dual-Labeled Probes for the 5’ nuclease assay.
Custom iScale Oligos DNA
iScale Oligos DNA are milligram and gram quantities of custom DNA oligonucleotides for commercial projects that require larger amounts of material.
Custom LAMP Primers
Custom LAMP Primers are manufactured using proprietary purification adjustments so primers performance optimally in loop-mediated isothermal amplification assays.
Custom Next-Gen Sequencing Oligos
Next-Gen Sequencing Oligos (NGSO) is custom universal and index adapter sequences manufactured to produce low levels of cross contamination.
GMP Oligos
Custom cGMP Oligos, available with custom specifications, are Commercial Oligos (raw materials) for MDx and LDTs.
Quality Control
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:
- Starting materials & chemistry
- Instrumentation & synthesis
- Sequence identity verification by mass spectrometry
- Purify verification by analytical HPLC
- Quantification by UV spectroscopy
- Final inspection
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