From the first prototype to production lot, we handle custom assay development as an extension of your team. From a single custom enzyme to a complete molecular or lateral flow assay, our team develops and manufactures in ISO 13485 certified and FDA cGMP compliant facilities in Grand Rapids (USA) and Toronto (Canada).
You probably come to us at a familiar point. You may have a prototype assay or a working device. The components inside are the bottleneck. Your internal options are clear: invest in expression, purification, QC, documentation, and the people to run all of it, or find a partner who already has the expertise and system in place.
Building enzyme manufacturing or assay manufacturing capacity in-house is a multi-year investment. While the science is hard, manufacturing is an underestimated challenge: Lot-to-lot reproducibility, host DNA contamination control, ISO 13485 documentation, and stability data are often the parts that take significant time and effort to get right.
We are built for specific kinds of projects. You will get the most value from us if you know your application well enough to tell us what success looks like.
Your product is differentiated rather than commodity. Your target sits in:
Mammalian expression, complex eukaryotic proteins requiring extensive post-translational modification, and commodity proteins like albumin and streptavidin are outside what we focus on. If your project falls there, we will tell you on the first call.
You keep your assay design, your device, and your IP. You may stay with us indefinitely or use us as the bridge while you build internal capacity. Both are valid reasons to start a project with us.
Because you need to be flexible, we are flexible. You may want a single component, like a polymerase at a non-standard concentration or a lyophilized bead format for an existing kit. Some projects are at an earlier stage and need to accelerate, so we assist with the entire assay, including reagent development, format selection, dispensing, and manufacturing.
You decide where we start.
We customize enzymes, master mixes, and buffers, and can provide complete formulations. Bring your own protein, or pull from our portfolio of 85+ enzymes. Chose from an extensive catalog of antibodies and antigens, including matched pairs tested in lateral flow assays, or have us customize yours.
Explore what we offerGet development services and manufacturing for PCR, qPCR, and isothermal amplification. Custom polymerases, isothermal RT, CAS, and master mixes. Wet dispensing into cartridges, plates, tubes, or vials. Kitting and warehousing available.
Explore what we offerImprove the sensitivity, reliability, and stability of your assay with key lateral flow assay components. Choose validated antibodies and antigens, PrimeCare membranes, and gold nanoshells that push sensitivity beyond colloidal gold.
Explore what we offerWe specialize in lyophilized beads, cakes, powders, and surface coatings. Bead capacity exceeds six million per month. Lyophilized control swabs freeze-dried directly to medical-grade applicators. Prototype turnaround typically within 10 business days.
Explore what we offerEvery project begins with a technical review. We want to understand your assay, your device, your application, and the constraints that brought you to us.
The questions are practical:
You will be talking directly with the scientist responsible for your project, from early feasibility through tech transfer into manufacturing. The person working on the assay is the person on your call.
If your application can be served by an off-the-shelf product from our portfolio, we will tell you. About 90% of our work is tailoring around proven enzymes and proven LFA components: a higher concentration, an alternative storage buffer, a different fill volume, a matched-pair switch. If the project is fully de novo, we put together a statement of work that includes the development scope. For projects that fall within our existing capabilities, we may invest in the early prototyping ourselves.
Custom assay development is iterative. We develop a prototype, you test it in your workflow, and we adjust based on your feedback. The cycle repeats until the reagent or assay performs the way your application needs it to. The scientist preparing your samples is the scientist on your call, which changes the speed of decisions and the quality of the collaboration between both teams.
For lyophilized products, we work from a library of excipient systems and optimized cycles for bead, cake, powder, and surface-coating formats. Bead diameters from 1.5mm to 5.0mm and reagent volumes from 3 to 75 microliters are within our standard range.
Our bacterial expression systems use proprietary vectors that produce more enzyme per liter of culture than the alternatives you would likely compare against.
Our LFA work draws on proprietary PrimeCare asymmetric membranes and gold nanoshell technology that pushes the sensitivity floor without adding optical hardware components.
Once your team has approved the prototype, we lock the product configuration. Specifications, formulation, fill volume, buffer, container, and QC release criteria are documented and frozen, then the product moves into our manufacturing system through a formal transfer.
Manufacturing happens in ISO 13485-certified and cGMP facilities. Each lot is released against the specifications documented during your development phase. QC includes the criteria common to molecular biology and immunoassays, where applicable: nuclease freedom, host DNA contamination, functional activity, sensitivity and specificity, and any custom assays your application requires to demonstrate proper functionality prior to release. Removing host DNA from an enzyme used in next-generation sequencing or sensitive amplification is not trivial. Our reproducible protocols are one of the more challenging processes to replicate in-house quickly.
Lyophilized products are filled and packaged under controlled humidity with nitrogen flushing, with bead capacity exceeding six million per month. Lateral flow products move through reel-to-reel manufacturing at scale more than five million tests per month, with prototype lots starting at 50,000 strips. Shelf-life claims are supported by accelerated and real-time stability data. Batch records, traceability, and release documentation are generated in parallel with production, formatted for your quality management system. Private-label packaging and lot-specific traceability are standard.
We manufacture in Grand Rapids, Michigan and Toronto, Ontario. Both facilities operate under an ISO certified quality system. You can choose where your product is made based on the requirements of your downstream application.
For IVD products serving the U.S. government or military, full domestic manufacturing is often a requirement. Our Grand Rapids facility supports projects where every step, from raw materials to final fill, must occur within the United States and is BioSecure Compliant. Our Toronto facility offers proximity to European and Canadian markets and houses our large-scale bead lyophilization capabilities. Cold-chain shipping within North America avoids the customs delays that affect overseas suppliers, which matters when iterative samples are moving back and forth during development.
The economics are competitive with offshore manufacturing. You get the cost profile of a non-domestic supplier with the supply chain reliability of a North American one.
A sequencing company developing its own engineered enzyme came to us through a referral. A CRO had worked with the company to screen the variant but could not scale it. We took on the manufacturing, supplied bulk material at the high concentration their internal manufacturing required, and stayed deferential to their IP throughout. They retained the engineered enzyme. We became their reagent manufacturer.
A company was making its own polymerase in-house and hitting capacity limits. Their workflow had been validated at a higher concentration than any vendor offered off the shelf. Rather than ask them to revalidate against our standard SKU, we matched the concentration and took over the supply. The capacity constraint disappeared.
An instrument company was developing an RNA sequencing pipeline and needed enzymes that did not exist in the marketplace. They were not sure what to measure or how to assign unit activity. We built the development from the ground up, including the activity assays, and delivered the reagents in an ambient-stable lyophilized format their device required. The follow-on project started a year later.
Send us a description of your project. We will follow up to schedule a technical review. The first conversation is with a scientist, not a sales representative.
If your project is a good fit, we will tell you what the custom assay development path looks like, what samples we can put in front of you, and what timeline is realistic. If it is not a fit, we will tell you that too, and we will try to point you to where you can get your project to the next step.
Assay developers are often faced with two paths to optimize reagents and enzyme performance: engineering new reagents or using an off-the-shelf version and tailoring its
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
Molecular diagnostic platforms, sequencing technologies, and point-of-care systems are becoming increasingly specialized. These devices often feature microfluidic cartridges, ultra-low reaction volumes, rapid cycling protocols, and
Fortis supports custom assay development across reagents, molecular assays, lateral flow assays, and lyophilized products from early prototyping through commercial manufacturing. Key applications include PCR, qPCR, isothermal amplification, NGS library preparation, point-of-care diagnostics, and lateral flow immunoassays.
Yes. Fortis can provide an individual component, such as a custom enzyme, master mix, antibody, membrane, or lyophilized bead, or support a complete assay program encompassing development, dispensing, manufacturing, kitting, and warehousing.
Fortis develops and manufactures custom enzymes, polymerases, reverse transcriptases, master mixes, buffers, and complete reagent formulations. Products can be customized by concentration, buffer, activity, fill volume, container, and liquid or lyophilized format.
Fortis develops lyophilized beads, cakes, powders, surface coatings, and control swabs. Lyophilization prototypes are typically available within 10 business days, with commercial bead manufacturing capacity exceeding six million units per month.