定制 cGMP 寡核苷酸

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 cGMP Oligos.

THE SUITE

The foundation of Custom cGMP Oligos is our suite with three laboratories: Synthesis, Purification, and Quality Control. The following applies:

• Manufactured in accordance with US GMP (21 CFR 820)
• Filled in classified cleanroom ISO 14664-1:2015 Class 8
• Site maintains ISO 13485 Quality Management System certificate

Benefits of oligos made under these quality and manufacturing systems include:

• Controlled & validated 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.

KEY CONSIDERATIONS

When selecting a vendor, at a minimum, it is crucial to ensure that any cGMP 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. A batch record is also significant in that it allows traceability for audits and proof of adherence to regulations.
• 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 cGMP 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 you preclinical study. We have the ability to scale with you, whether from R&D to growth beyond commercialization or the need for every 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.

FORMING A PARTNERSHIP

As part of our Commercial Oligos offering, we believe forming partnerships with customers is important to foster successful Custom cGMP Oligos manufacturing campaigns.

The Process

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, we will skip these steps and accelerate the process.

For a more in-depth view of this process, please see the Project Expertise section of our Commercial Oligos offering. Regardless, whether you work in R&D, process development, manufacturing, or procurement, our flexibility will meet the requirements of your specific role.

OUR CAPABILITIES

As part of our Commercial Oligos offering, our Custom cGMP 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.

Custom DNA Oligos

Basic PCR primers, SYBR^® Green Primers, isothermal amplification primers, sequencing primers and more.

Custom qPCR Probes

Dual-Labeled Probes, Molecular Beacons & LightCycler^® Probes.

Next-Gen Sequencing Oligos

Custom next-generation sequencing adapters.

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.