Development teams building diagnostic, sequencing, and point-of-care (POC) platforms often start a new product cycle with off-the-shelf reagents. These are typically catalog items that are widely available, not just to developers, but also to research scientists and laboratories, making them an accessible and practical starting point for early feasibility work. That approach makes sense for speed, but as platforms become more specialized (smaller volumes, tougher sample matrices, faster cycling, cartridge formats, or lyophilized storage), generic reagents can become the bottleneck: they work, just not with the reliability required in real-world conditions.
Generic reagents can become the bottleneck: they work, just not with the reliability required in real-world conditions.
In many cases, moving from “works in principle” to “works consistently in our system” requires customization. Custom reagents optimized for concentration, buffer, stability profile, or device format for a specific platform can improve performance, but product development teams rarely have either the necessary research resources or manufacturing expertise for customization efforts.
That’s where the customized catalog path comes in. Fortis Life Sciences has developed its reagent business to meet this exact need; providing development teams with purpose-built reagents that behave reliably in their customers’ systems, avoiding costly redesigns.
In many cases, moving from “works in principle” to “works consistently in our system” requires customization.
Outsourcing custom reagent production has significant advantages beyond convenience. It is a strategic decision that affects development pace, assay performance, regulatory compliance, and long-term scalability. This article describes the process of choosing off-the-shelf catalog reagents, their customization, and how Fortis approaches these unique projects.
What customized from catalog means
Catalog customization is a set of modifications that make an existing reagent better fit your assay and device requirements. These modifications can include:
- Concentration changes to reduce variability, improve performance and support smaller reaction volumes, and/or tune performance.
- Buffer formulations to match reaction chemistry, optimized storage buffers, additives to enhance functionality and stability.
- Glycerol-free and lyophilization-compatible formats for ambient stability and/or integration into a proprietary assay cartridge or microfluidic device.
- Flexible fill/finish and packaging/labeling options for OEM use (bulk, aliquots, white‑label options).
- Storage and stability configuration, depending on cold chain vs. lyophilization‑ready vs. lyophilized.
When is the catalog-customized path the right move?
Fortis Life Sciences offers a wide variety of off-the-shelf reagents for PCR, RT-PCR, isothermal amplification, inhibitor-tolerant workflows, NGS, CRISPR applications, and sample prep. While some of these reagents are components in existing Fortis catalog products, the vast majority are part of a collection available exclusively to OEM partners.
Starting with a catalog product such as polymerase, ligase, or reverse transcriptase is the easiest approach, when the reagent activity profile and functionality is already acceptable for your assay and the bottleneck is format or device compatibility. If the catalog reagent is functional in the assay, only small changes to its format might be required to obtain optimal configuration. Customization programs can move quickly, especially because Fortis has well established QC methods for catalog products. The transition from R&D to manufacturing is simplified with established reagents, and it is more feasible to move quickly towards commercialization with consistent lots.
Why do custom reagents matter?
Reagents may look similar on paper, but the difference between “standard” and “custom” often becomes evident in performance testing. Development teams get a good sense of baseline reagent performance during the early prototyping stage and look to improve that performance as the assay workflow is refined. Performance gains, however, can’t always be achieved with catalog reagents. Even small variations in reagent concentration, buffer composition, or purity can significantly influence assay performance. This is where custom reagents can help.
As an example, a ligase may require higher concentration to achieve sufficient activity in a novel, one-pot reaction setup. A polymerase that works in an early R&D prototype may need storage buffer reformulation when the assay is ported over to a cartridge system that utilizes microfluidics with greater surface tension. If the cartridge is sold as an ambient-stable consumable associated with a point-of-care device, reagent lyophilization may also be required. These are not rare or atypical cases; they are common issues that arise as products are developed. By providing teams with control over the formulation, concentration, and storage configuration, custom reagents can address and overcome these problems while achieving reliable performance and the stability required for commercialization.
Why is outsourcing reagent customization so effective?
Companies can move faster and still deliver high performance products by outsourcing custom reagent development and manufacturing. Instead of troubleshooting fermentations or running purification columns, your development scientists can focus their efforts on their key priorities: designing the device, optimizing the assay, advancing through verification and validation phases, and on regulatory compliance.
Outsourcing custom reagent development is not just efficient; it can be essential in reaching the market without delay. Fortis Life Sciences has a broad reagent portfolio and can quickly tailor formulations and deliver new formats, often in eight weeks or less.
How Fortis Life Sciences customizes reagents
The ability to design manufacturing processes around reagent needs is what separates Fortis from catalog-only suppliers. The process begins with a technical consultation where Fortis development scientists examine the manufacturing workflow, the required performance characteristics, and any unique specifications related to formulation, concentration, stability, or device integration.
From there, Fortis develops prototype batches, adjusting expression systems, buffer compositions, stabilizers, or storage configurations as needed. Some development teams require a high-concentration bulk reagent that can be diluted into multiple SKUs. Others require glycerol-free or lyophilized formats compatible with point-of-care devices.
The ability to design manufacturing processes around reagent needs is what separates Fortis from catalog-only suppliers.
Once the optimal formulation is established, it’s transferred into Fortis’ controlled manufacturing environment, where consistency, documentation, and reproducibility take center stage. Our ISO 13485 Quality System forms the backbone on which this system works, ensuring a high-level reproducibility between manufactured lots.
Development teams that have novel devices, kits, or proprietary workflows, can benefit from Fortis’s strong history and proven track record in applications development. With a broad range of projects, highlights include applications in point-of-care nucleic acid amplification, next-generation sequencing library prep, custom reagents involved in microfluidic cassettes, and conversion of reagents into lyophilized formats.
Quality systems and supply chain reliability are crucial
When custom reagents are used in products destined for regulated applications including clinical diagnostics, military applications, or government contracts, the quality system used to manufacture those reagents becomes just as important as the reagents themselves. Projects benefit from the structure provided by the strict requirements of an ISO 13485 certified Quality System, starting with early-stage feasibility and specification development and transitioning into large scale manufacturing. Fortis strategically integrates robust quality controls at appropriate stages of production, including nuclease testing, host-DNA background assays, stability studies, and confirmation of functional performance. Risk can be further reduced as the products are “Made in the USA” and are BIOSECURE Act compliant.
By choosing Fortis, teams get flexibility for quick development, ISO-certified and GMP compliant manufacturing, and advanced stabilization and lyophilization of manufactured products.
Supply chain reliability is also critical for any successful product. Developing a custom reagent is only part of the challenge, while maintaining uninterrupted supply is equally important. Development teams should look for redundant manufacturing footprints across North America, as these help avoid customs delays, mitigate cold-chain failures, and reduce geopolitical risk.
By choosing Fortis, teams get flexibility for quick development, ISO-certified and GMP compliant manufacturing, and advanced stabilization and lyophilization of manufactured products. The ability to cover all three is a major differentiator, especially for development teams that need OEM-grade manufacturing support rather than just R&D-scale reagent work.
Summary
Custom reagents have become essential for building and manufacturing competitive diagnostic and sequencing products. Customizing a catalog or standard reagent can include new buffers, optimized component concentration, or modification to a lyophilization format. Choosing to outsource custom reagent development is more than a tactical decision, it’s a foundational strategy for speed, reliability, and long-term competitive advantage. Outsourcing partners should bring fast development, strong manufacturing discipline, and advanced stabilization capabilities.
Fortis is set up so your development team can stay focused on building and validating your product—while obtaining a reagent that is tailored to your exact workflow. Your team will access rapid prototyping, scalable manufacturing, and mature and robust quality systems; Fortis is a partner that can translate complex performance requirements into a stable, reproducible reagent supply. This enables a more streamlined path from concept to commercialization, without the burden of building and maintaining expertise for reagent development and production in-house.
Fortis is set up so your development team can stay focused on building and validating your product—while obtaining a reagent that is tailored to your exact workflow.
If a generic, off-the-shelf enzyme falls short in your assay, read our article on de novo customization, or the one comparing the two paths: de novo and off-the-shelf.
Learn more about custom reagent development – Contact us