Lee Biosolutions
Lee Biosolutions (now Medix Biochemica USA Inc.) is an ISO 13485-certified US manufacturer of high-purity native antigens, proteins, enzymes, antibodies, and biological specimens used as critical raw materials by in vitro diagnostic manufacturers and life science research institutions worldwide.
- Company typePrivate
- Founded1983
- HeadquartersMaryland Heights, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Lee Biosolutions does
Lee Biosolutions (legally Lee Biosolutions, Inc., now operating as Medix Biochemica USA Inc.) is a US-based specialty manufacturer of high-purity native biological raw materials serving the in vitro diagnostic (IVD) and life science research markets. Founded in 1975 (with the corporate entity established in 1983) and headquartered in Maryland Heights, Missouri, the company produces antigens, proteins, enzymes, antibodies, biochemicals, and biological specimens through novel extraction methodologies combined with classical chromatography techniques (size exclusion, ion exchange, gel filtration). Its product portfolio spans more than 1,000 catalog items across four primary categories — antigens/enzymes, biologicals (human blood-derived and other specimens), biochemicals, and antibodies — with notable depth in human plasma-derived lipoproteins (LDL, HDL), immunoglobulins (IgG, IgA, gamma globulin), transferrin variants, and cardiac markers (myoglobin, creatine kinase MB, myeloperoxidase).
The company operates as the US subsidiary of Medix Biochemica, a Finnish-headquartered global supplier of IVD critical raw materials, following a 2024 rebranding. Revenue is generated through three primary streams: catalog unit sales of biological raw materials priced per milligram, gram or activity unit (with examples ranging from tens to over a thousand dollars per unit); custom GMP-grade manufacturing, process transfer, validation, and analytical testing services for diagnostic manufacturers; and distribution of human biological specimens (serum, plasma, urine, saliva, tissues) for protein isolation, diagnostics, and medical research. Customers span IVD manufacturers (clinical calibration controls, diagnostic assay manufacturing, quality control materials — primary segment), life science research institutions and academia (primary segment), pharmaceutical companies (secondary), and forensic laboratories (secondary). Distribution combines a direct e-commerce storefront (leebio.com), phone/fax/email ordering, and an international distributor network.
The business is ISO 13485 certified under medical device quality management standards, supporting qualification of its materials in regulated IVD manufacturing workflows. Go-to-market is dual-track: a transactional e-commerce channel serving research customers and academics (including a 10% academic discount program) and an enterprise sales motion for bulk supply contracts, custom preparations, and GMP-grade manufacturing engagements. No independent funding activity, leadership team bios, or financial disclosures are available in the source material, consistent with the company now operating as a wholly-owned subsidiary within the larger Medix Biochemica group.
Lee Biosolutions firmographics
Firmographics- Name
- Lee Biosolutions
- Legal name
- Lee Biosolutions, Inc.
- Website
- https://leebio.com
- Company type
- Private
- Founded year
- 1983
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Lee Biosolutions (now Medix Biochemica USA Inc.) is an ISO 13485-certified US manufacturer of high-purity native antigens, proteins, enzymes, antibodies, and biological specimens used as critical raw materials by in vitro diagnostic manufacturers and life science research institutions worldwide.
- Ownership category
- akta.pro rank
Lee Biosolutions industry classification
Industry- Product category
- In Vitro Diagnostic Raw Materials
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Testing Laboratories (8734)
- akta.pro primary industry
- Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)
- akta.pro secondary industry
- Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls) (HLAAAMAL)
Keywords
Where Lee Biosolutions is headquartered
LocationHeadquarters
- HQ city
- Maryland Heights
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Lee Biosolutions business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Product Sales - Antigens, Proteins and Enzymes: Sale of high purity antigens, proteins, enzymes, antibodies, biochemicals and biologicals for research and IVD manufacturing. Products sold in various unit sizes with bulk ordering options available.
- Custom Manufacturing Services: Custom diagnostic and GMP-grade manufacturing, product and assay development, process transfer, validation and optimization, and analytical testing services.
- Biological Specimen Distribution: Distribution of human biological fluids and tissues including serum, plasma, urine, saliva, and other specimens for protein isolation, diagnostic manufacturing and medical research.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Unit pricing for catalog products |
| Other | Multi-year contract | Bulk and custom orders |
| Other | Annual | Academic discount program |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels3 records
Lee Biosolutions product offering
Product offeringCore offering
Lee Biosolutions manufactures and sells high purity antigens, proteins, enzymes, antibodies, biochemicals, and biological specimens that serve as critical raw materials for in vitro diagnostic (IVD) test manufacturers and life science research laboratories. The company operates an e-commerce catalog of more than 1,000 SKUs organized into four product families (antigens/enzymes, biologicals, biochemicals, antibodies), and complements catalog sales with custom GMP-grade manufacturing, assay development, process transfer/validation, and analytical testing services.
Product overview
Lee Biosolutions (now Medix Biochemica USA Inc.) is a critical raw material manufacturer for the in vitro diagnostic (IVD) market. The company offers a diverse portfolio of biological products organized into four main categories: Antigens/Enzymes (proteins, enzymes, standards/controls, conjugates), Biologicals (human blood-derived, human other biologicals like urine, saliva, semen, fecal matter, swabs, tissues, animal blood-derived), Biochemicals (chemicals, buffers/diluents), and Antibodies (monoclonal, polyclonal, antisera). Key products include lipoproteins (LDL, HDL), immunoglobulins (IgG, IgA, Gamma Globulin), transferrin variants (Apo, Holo, Sidero), cardiac markers (Myoglobin, Creatine Kinase MB/MM/BB, Myeloperoxidase), C-Reactive Protein, Alpha-Fetoprotein, and various enzymes. The company also provides GMP manufacturing, custom purification, assay development, and analytical testing services. Medix Biochemica acquired ViroStat LLC to expand its infectious diseases antibody offering.
Differentiator
Problem solved
Functional benefit
Products and services
- Antigens, Proteins and Enzymes High purity antigens, proteins, and enzymes (including standards/controls and conjugates) produced through novel extraction methodologies and classical chromatography techniques, intended for life science research and in vitro diagnostic applications.
- Human and Animal Biologicals High quality biological samples and specimens including human blood-derived products, human other biologicals (urine, saliva, semen, fecal matter, swabs, tissues), and animal blood-derived products for research, development, and manufacturing.
- Biochemicals (Reagents, Chemicals and Solutions) High purity biochemical products including chemicals and buffers/diluents used as critical raw materials in biopharmaceuticals, cell culture media, clinical diagnostic manufacturing, and life science research worldwide.
- Antibodies (Monoclonal, Polyclonal, Antisera) Affinity purified monoclonal, polyclonal antibodies and antisera generated and produced with high specificity and reactivity, used for labeling and immobilizations in ELISAs, Western blotting, RIA, and immunohistochemistry applications.
- Custom Diagnostic and GMP-grade Manufacturing Services Custom diagnostic and GMP-grade manufacturing, product and assay development, process transfer, validation, and optimization services for IVD manufacturers and research customers.
- Analytical Testing and Technical Support Services Analytical testing and technical support services for biological materials and diagnostic products, covering characterization and validation support.
- ViroStat Infectious Disease Antibodies and Antigens Infectious disease antibodies and antigens acquired through Medix Biochemica's acquisition of ViroStat LLC, supplied to in vitro diagnostics manufacturers.
Quantifiable outcome
- ISO 13485 certified manufacturing operations
- +1 more outcomes
Companies that use Lee Biosolutions
Customer profileSegments4 records
Ideal customer profiles4 records
Lee Biosolutions technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Lee Biosolutions partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Medix BiochemicacoreLee Biosolutions is now Medix Biochemica USA Inc., operating as part of the global Medix Biochemica group. Medix Biochemica is a world-leading supplier of critical raw materials for the in vitro diagnostics industry, headquartered in Espoo, Finland. The acquisition has enabled expansion of infectious disease antibody offerings.
- ViroStat LLCcoreViroStat LLC, a US-based company and global leader in infectious disease antibodies and antigens for IVD manufacturers, was acquired by Medix Biochemica. This acquisition expands Medix Biochemica's infectious diseases antibody portfolio, combining ViroStat's expertise with Lee Biosolutions' existing capabilities.
Scale indicators4 records
Recent moves6 records
Expansion highlights4 records
Lee Biosolutions competitors and assessment
Company assessmentDirect peers
- Bio-Rad Laboratories: Bio-Rad is a leading manufacturer of IVD quality controls, standards, and reagents, with a long-standing Life Science segment that supplies proteins, antibodies, and biochemicals to diagnostic manufacturers—directly comparable to Lee Biosolutions' IVD raw material business.
- Surmodics: Surmodics' Diagnostics Division supplies critical raw materials (antigens, antibodies, enzymes) to IVD manufacturers, including microarray and immunoassay reagents—closely matching Lee Biosolutions' product portfolio and customer base.
- Rockland Immunochemicals: Rockland produces antibodies and immunological reagents for life science research and diagnostic applications, with comparable antibody production capabilities to Lee Biosolutions' affinity-purified polyclonal and monoclonal offerings.
- BBI Solutions (Sona Nanotech): BBI Solutions manufactures IVD-grade antibodies, antigens, and gold nanoparticles for diagnostic test manufacturers—a close niche peer in the IVD raw materials supply chain.
- HyTest (Thermo Fisher Scientific): HyTest, acquired by Thermo Fisher, is a global leader in IVD antibodies and antigens, particularly for cardiac and infectious disease markers—directly comparable to Lee Biosolutions' native human proteins and antibody portfolio.
- Meridian Life Science (Revvity): Meridian Bioscience (now part of Revvity) produces antigens, antibodies, and biological reagents for IVD manufacturers, with deep capabilities in infectious disease diagnostics—directly overlapping with Lee Biosolutions' offerings.
Broad incumbents
- Thermo Fisher Scientific: Thermo Fisher is the largest life sciences tools company globally, with a diagnostics and bioscience segment that supplies proteins, antibodies, and biologicals to IVD manufacturers—a broad incumbent that competes in adjacent rather than niche categories.
- Medix Biochemica (Parent Group): The parent group headquartered in Finland is a world-leading IVD raw material supplier with a much larger global footprint and product portfolio (including ViroStat infectious disease antibodies); it is the natural reference point for valuing Lee Biosolutions' standalone contribution to the group.
- Roche Diagnostics: Roche is the world's largest IVD company, with both in-house raw material production and a broad diagnostic test portfolio. It represents a potential customer and competitor, with vertical integration in many of the same biological reagents Lee Biosolutions supplies.
- MilliporeSigma (Merck KGaA): MilliporeSigma is a major incumbent in life science reagents, biochemicals, and analytical products with a vastly broader catalog and global scale; it overlaps with Lee Biosolutions' biochemicals and reagent categories but serves a much wider market.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Lee Biosolutions social profiles
Digital presenceLee Biosolutions compliance and trust
Trust signalCompliance1 record
Lee Biosolutions financial estimates
Financial estimateRevenue estimate
Valuation estimate
Lee Biosolutions leadership team
Management profileNumber of profiles
Lee Biosolutions funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Lee Biosolutions M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Lee Biosolutions
What does Lee Biosolutions do?
Lee Biosolutions manufactures and sells high purity antigens, proteins, enzymes, antibodies, biochemicals, and biological specimens that serve as critical raw materials for in vitro diagnostic (IVD) test manufacturers and life science research laboratories. The company operates an e-commerce catalog of more than 1,000 SKUs organized into four product families (antigens/enzymes, biologicals, biochemicals, antibodies), and complements catalog sales with custom GMP-grade manufacturing, assay development, process transfer/validation, and analytical testing services.
Is Lee Biosolutions a public or private company?
Lee Biosolutions is a private company. It is classified as corporate owned and is currently operating.
When was Lee Biosolutions founded?
Lee Biosolutions was founded in 1983. It employs 11 to 50 people.
Where is Lee Biosolutions based?
Lee Biosolutions is headquartered in Maryland Heights, United States, in the North America region.
How does Lee Biosolutions make money?
Three revenue lines are on record. Product Sales - Antigens, Proteins and Enzymes are the primary driver. The others are custom Manufacturing Services and biological Specimen Distribution.
Who are Lee Biosolutions's main competitors?
Direct peers on record are Bio-Rad Laboratories, Surmodics, Rockland Immunochemicals, BBI Solutions (Sona Nanotech), HyTest (Thermo Fisher Scientific) and Meridian Life Science (Revvity). Broad incumbents are Thermo Fisher Scientific, Medix Biochemica (Parent Group), Roche Diagnostics and MilliporeSigma (Merck KGaA).
Does Lee Biosolutions have an API?
No public API is recorded for Lee Biosolutions.
What industry is Lee Biosolutions in?
Lee Biosolutions's product category is In Vitro Diagnostic Raw Materials. Its primary akta.pro industry code is HLAGAIAI, Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes), with a secondary code of HLAAAMAL, Biomarker Assay & Reagent Development (LDT/IVD assay design, antibodies/standards/controls). Its NAICS code is 325413 and its SIC code is 2835.