Contract Development Manufacturing Services
Lyophilization, Formulations, Reagents, Custom Enzymes
Customized Contract Manufacturing for Diagnostics, Life Sciences and Cosmetics
Fortis Diagnostics provides your team with end-to-end IVD assay development and manufacturing support, from custom recombinant proteins and antibodies to lyophilized reagents. With our integrated development and manufacturing teams, you are delivered fast prototypes and iterations. Scaling into manufacturing is seamless, backed by consistent quality that has delivered for over 18 years, with strong ISO 13485 audit outcomes across multiple certification cycles. Major biotech and healthcare companies rely on us for their diagnostic assay development and manufacturing.
We quietly make the reagents and assays for the companies you know and trust.
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ISO Certified
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Estabilished In
- 0M+
Assays Delivered
Lyophilization Services
- Beads- 1.5mm-5mm dia.
- Cakes- 25µl to 2ml
- Surface coatings
- Unit dose or bulks
- Colored additives
- Cartridges & ampoules
- Vials, chips & tubes
- +6M beads per month
Reagents & Enzymes
- Development and manufacturing
- Wide range of catalog enzymes
- Bacterial expression
- FPLC purification
- Wide range of modification chemistries
- QC assay optimization
Membranes
- Primecare™ membranes separate RBCs from plasma
- Customizable for IVD, lateral flow, POC
- Resistant to protein binding
- Variety of specifications, thickness & pore size
- High separation efficiency
Diagnostic Assay Development Services
Molecular Assay Development
- Customized enzymes & proteins
- Development & manufacturing
- Lyophilization
- Formulation optimization
- Bulk reagents & controls
- Cartridges, plates, tubes, vials
- Kitting & Warehousing
Lateral Flow Assay Development
- Catalog antibodies & antigens
- Antibody design & manufacturing
- Custom membranes
- Proprietary nanomaterials
- Prototype lots
- Controls
- Kitting & Warehousing
Level-up your assay
Why Choose Fortis? Quality You Can Trust
With more than a decade of strong ISO 13485 certification audits, our products are relied on by top tier companies for their key diagnostic platforms: from NGS to lateral flow, and PCR to isothermal amplification. We deliver without drama, and from our two core manufacturing sites we support both US domestic production and European/Asian organizations.
Frequently Asked Questions (FAQs)
Typically, we will provide a formulation to you (or use your formulation) and perform a small non-GMP manufacturing run. Your team will receive and approve the reagents, after which we scale into GMP manufacturing.
We provide lyophilized beads and cakes, proteins, enzymes, and buffers.
Yes, we can do this.
Toronto, Canada & Grand Rapids, MI USA