Selecting an oligo supplier is about far more than securing primers and probes at the right price. The right partner can influence assay performance, manufacturing scalability, regulatory readiness, supply-chain resilience, and long-term commercial success.
In our webinar Assessing Molecular Diagnostic Suppliers for Design Support and Scale-Up Readiness, Dr Amanda Weiner, Commercial Application Scientist and Bo Heinz, Oligos Product Manager outline a practical three-step framework for evaluating suppliers.
Their central argument is that supplier selection should start long before procurement and continue well beyond initial qualification. Decisions made during assay development can affect manufacturing, quality, regulatory readiness and supply security years later.
As Amanda notes, “Supplier choice is more than a procurement decision. It’s a way to manage long-term risk from very early on.”
Step 1: Define your requirements and future manufacturing needs
Many developers focus on immediate priorities such as speed, cost and availability during early assay development. However, commercialisation introduces new requirements, including manufacturing capacity, documentation, traceability and tighter quality controls.
Before comparing suppliers, organisations should establish clear requirements for:
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Oligo type and specifications
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Quality-control expectations
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Delivery format and formulation
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Manufacturing scale requirements
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Research use versus clinical-grade production.
A key consideration is distinguishing between the needs of today's development programme and those of a future commercial product. Teams should first determine what they actually require: the type of oligo, QC expectations, delivery format and price ranges.
Looking ahead can identify whether a supplier will be a viable partner as production volumes increase and regulatory demands grow.
Dr Amanda Weiner:
Supplier choice is more than a procurement decision. It’s a way to manage long-term risk from very early on.
Think about manufacturability early
A design that performs well in the laboratory is not always straightforward to manufacture at scale. Manufacturing considerations should therefore be incorporated into assay development as early as possible.
Sequence design, probe chemistry, fluorophore selection, modifications and purification requirements can all influence manufacturing complexity, yield and cost. Some probe formats require additional synthesis and purification steps that can reduce final output.
As Bo explains, “For some of these fluorophores and some of these formats, the complexity of the synthesis impacts the final yield.” .
Step 2: Evaluate quality, scalability and supply-chain resilience
Once requirements are defined, it is important to assess whether a supplier can consistently deliver quality while supporting future growth.
Look closely at manufacturing consistency
Manufacturing consistency is often overlooked during early supplier evaluations, yet participant polling identified it as the leading scale-up challenge.
In fact, inconsistent product quality was cited as one of the primary reasons for switching suppliers.
Quality systems should therefore be examined beyond basic specifications. Developers should understand:
- How identity, purity and yield are verified
- What in-process quality controls are in place
- How deviations are managed
- How manufacturing data is documented and traced.
- Qualifying secondary suppliers
- Validating equivalent materials
- Identifying single-source dependencies
- Assessing multisite manufacturing capabilities
- Reviewing surge-capacity options.
“Everything that leaves our factory receives mass spec and uHPLC and this information is available on our certificate of analysis.” says Bo.
For clinical and regulated applications, in-process controls have become particularly important. As Amanda explains, ISO 13485 manufacturing involves controlled quality checks throughout production, supported by comprehensive documentation and traceability systems.
Bo Heinz:
Everything that leaves our factory receives mass spec and uHPLC and this information is available on our certificate of analysis.
Ensure the supplier can scale with you
Growth requires more than increased manufacturing capacity. Suppliers must also be capable of scaling their quality and compliance frameworks alongside production volumes.
Amanda emphasizes diagnostic developers need suppliers that can scale in both capacity and compliance frameworks.
Manufacturers with experience supporting products from prototype through commercial launch are often better positioned to navigate technology transfer, changing regulatory requirements and increasing production demands.
Build supply-chain resilience before you need it
A strong supply chain can be just as important as a strong assay. As Amanda says: “Relying on a single supplier is probably one of the biggest hidden risks.”
To reduce risk, developers should consider:
Supply chain resilience should be built proactively, not only in response to disruptions. Identifying and validating backup suppliers helps safeguard production timelines and ensure business continuity when unforeseen issues arise.
Step 3: Build a strategic partnership for long-term success
Supplier evaluation does not end with qualification. Long-term success depends on maintaining an active, collaborative relationship as assay requirements evolve.
Make technical support part of the decision
The most valuable suppliers are those who provide expertise that extends beyond manufacturing.
Support may include sequence review, assay optimisation, manufacturability assessments and assistance with technology transfer from small-scale development to large-scale production.
“We'll look at customer sequences. We have an in-house scientific services team that will help and work on those tech transfers from small R&D developments all the way up to GMP or large-scale bulk synthesis,” says Amanda.
As programmes advance, open communication becomes increasingly important. Changes in assay design, production forecasts and timelines can all affect material planning and manufacturing readiness.
Manage quality issues collaboratively
Even the strongest supplier relationships will occasionally encounter challenges. The distinguishing factor is how those challenges are addressed. “The best suppliers don't get defensive. They get curious,” says Amanda.
Rather than assigning blame, effective partnerships rely on shared investigations supported by data from both organisations.
Regular supplier reviews, scorecards and performance discussions can help track trends in quality, delivery performance and responsiveness while creating a structured process for continuous improvement.
Looking beyond today's requirements
Assay development rarely follows a straight path. Designs evolve, manufacturing volumes increase, regulatory expectations shift and market demand changes over time.
The framework presented by Amanda and Bo encourages teams to look beyond price and delivery times. Defining requirements early, evaluating manufacturing capabilities thoroughly and maintaining strong supplier relationships can help reduce risk throughout development and commercialisation.
Ultimately, the goal is alignment across the product lifecycle. In the words of Amanda, “At the end of the day, with your primary and your secondary suppliers, it's really just about keeping everybody rowing in the same direction.”
For more insights from Amanda and Bo about assessing and choosing suppliers, stream the webinar on demand or click here to get in touch with one of our experts or to discuss your oligo supplier needs.
