Calbiotech
Calbiotech is an FDA-registered, ISO 13485-certified California CDMO specializing in immunoassay development and contract manufacturing, offering custom assay development, reagent manufacturing, microplate coating, and a catalog of 266 ELISA kits and reagents to global IVD companies, pharmaceutical/biotech firms, and research laboratories.
- Company typePrivate
- Founded1998
- HeadquartersEl Cajon, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Calbiotech does
Calbiotech is a California-based, FDA-registered, ISO 13485:2016-certified contract development and manufacturing organization (CDMO) specializing in immunoassay development. Founded in 1998 and headquartered in El Cajon, California, the company has accumulated 25+ years of expertise developing and distributing more than 150 immunoassay kits (ELISA, Chemiluminescent ELISA, molecular, and multiplex formats) across 40+ countries. Its service offering spans the full IVD value chain — custom assay development, contract manufacturing, reagent formulation and filling, microplate coating, dispensing/labeling/packaging, and kitting and fulfillment — under cGMP-validated quality systems.
Calbiotech operates a dual revenue model combining enterprise contract manufacturing with a catalog of research-use-only products. On the services side, it engages directly with global IVD companies, pharmaceutical and biotech firms, and medical device companies through quote-based, project-managed engagements with technical transfers completed in as little as three months. Manufacturing capabilities include automated microplate coating at throughputs up to 1,000 plates/hour with lot-to-lot CV below 2%, batch sizes ranging from 50 to 50,000 vials, and custom packaging from 0.25 mL to 500 L. On the products side, the company sells research ELISA kits priced at $250–$750, reagents and substrates starting at $10, veterinary and neonatal screening kits, preclinical animal-model ELISAs, the Immunovision autoimmune antigen/antibody line, and Moduline laboratory automation equipment ranging from $195 to $2,500 via a Shopify e-commerce storefront.
The company's go-to-market is sales-led, with field-based direct engagement for custom CDMO projects and a strategic U.S.-manufacturing positioning ('Manufacture in the USA') that targets global diagnostics firms seeking to avoid tariffs, compress logistics, or establish a regulated U.S. production footprint. Recent strategic activity includes a November 2025 co-development partnership with Ignite Biomedical and Liquid Biosciences for Autism Spectrum Disorder diagnostic assays based on mRNA biomarkers with reported >90% sensitivity and specificity. Calbiotech is privately held with no disclosed institutional investors, no recent funding rounds, and operates with 11–50 employees.
Calbiotech firmographics
Firmographics- Name
- Calbiotech
- Legal name
- Calbiotech, Inc.
- Website
- https://calbiotech.com
- Company type
- Private
- Founded year
- 1998
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Calbiotech is an FDA-registered, ISO 13485-certified California CDMO specializing in immunoassay development and contract manufacturing, offering custom assay development, reagent manufacturing, microplate coating, and a catalog of 266 ELISA kits and reagents to global IVD companies, pharmaceutical/biotech firms, and research laboratories.
- Ownership category
- akta.pro rank
Calbiotech industry classification
Industry- Product category
- Contract Diagnostic Manufacturing (CDMO)
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Drug Substance–Drug Product Integrated CDMO (HLAGABAG)
- akta.pro secondary industries
- Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)
Keywords
Where Calbiotech is headquartered
LocationHeadquarters
- HQ city
- El Cajon
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Calbiotech business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Supply Chain, Infrastructure, Marketing or Sales
Revenue model
- Contract Manufacturing Services: End-to-end IVD production including assay manufacturing, reagent preparation, and kit assembly. Revenue generated through per-batch manufacturing fees, with scalable batch sizes from pilot lots to full commercial production.
- ELISA Kits and Research Products: Sale of catalog ELISA kits for research use (RUO), reagents, substrates, antigens, and antibodies. Products priced per unit (e.g., $250-$750 for ELISA kits, $50-$800 for reagents). Revenue from one-time product purchases.
- Custom Reagent Manufacturing: cGMP compliant reagent preparation, formulation, and filling services. Pricing starting at $1 per filled vial with 500 vial minimum. Revenue from unit-based manufacturing fees.
- Microplate Coating Services: Coating services for microplates with pricing starting at $40 per fully processed plate with 50 plate minimum. High-throughput capability up to 1000 plates/hour.
- Moduline Systems Products: Sale of modular laboratory equipment including dispensers, aspirators, and manifolds (e.g., $500-$2,500 for manifold systems). Revenue from capital equipment sales.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | Research ELISA Kits - Standard catalog products for biomarker research |
| Unit Pricing | Pay-as-you-go | Reagent Preparation - Custom manufacturing services |
| Unit Pricing | Pay-as-you-go | Microplate Coating - Processing services for coated plates |
| Unit Pricing | Pay-as-you-go | Reagents & Substrates - Buffer solutions and assay components |
| One time/ perpetual license | Pay-as-you-go | Moduline Systems - Laboratory automation equipment |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels7 records
Calbiotech product offering
Product offeringCore offering
Calbiotech is a CDMO (Contract Development and Manufacturing Organization) specializing in immunoassay development and manufacturing. It sells catalog ELISA kits, reagents, antigens/antibodies, and laboratory equipment, and provides custom assay development, contract manufacturing, reagent preparation, microplate coating, and kitting/fulfillment services to IVD manufacturers, pharmaceutical firms, and biotech companies from its FDA-registered, ISO 13485:2016-certified facility in El Cajon, California.
Product overview
Calbiotech is a California-based, FDA-registered, ISO 13485:2016-certified CDMO (Contract Development and Manufacturing Organization) specializing in immunoassay development and manufacturing. The company's product portfolio centers on ELISA technology with offerings spanning Research ELISA Kits for human and animal biomarkers, Reagents & Substrates, and the Immunovision brand of autoimmune antigens and antibodies. The Moduline Systems product line provides laboratory automation equipment including dispensers and syringes. Calbiotech's service offerings include Custom Assay Development (ELISA, CLIA, molecular), Contract Manufacturing, Reagent Preparation, Microplate Coating, Dispensing/Labeling/Packaging, and Kitting & Fulfillment services. Additional specialty products include Neonatal Screening assays and Preclinical Research ELISAs for animal models. The company distributes to over 40 countries and operates GMP/ISO 13485-compliant manufacturing facilities.
Differentiator
Problem solved
Functional benefit
Brands
- Immunovision: Sub-brand offering antigens and antibodies for autoimmune disorder diagnostics, including nRNP Complex, Smith (Sm) Antigen, Centromere antibodies, and various autoimmune markers.
- Moduline Systems
Products and services
- Research ELISA Kits A broad range of RUO (Research Use Only) ELISA kits for human and animal biomarkers, referenced in peer-reviewed studies worldwide. Includes hormone, autoimmune, cancer, infectious disease, and other marker assays.
- Reagents and Substrates Diagnostic reagents including streptavidin-coated microplates, PBS buffer, coating buffer, wash buffer, and stop solution for ELISA and immunoassay workflows.
- Immunovision (Antigens and Antibodies) Autoimmune disease antigens and antibodies including nRNP Complex, Smith (Sm) Antigen, SSA/SSB antigens, Scl-70, Jo-1, histones, and hepatitis-related antibodies for research and diagnostic applications.
- Moduline Systems Laboratory automation equipment including 96-well manifolds for dispense/aspirate operations, syringes (2.5mL, 5mL), and rotary valves for liquid handling systems.
- Neonatal Screening Products DBS-optimized assays for TSH, 17-OH Progesterone, Biotinidase, and other key neonatal screening markers.
- Preclinical Research ELISAs Specialized ELISAs designed for mouse and rat samples for drug discovery, toxicology, and academic research applications.
- Veterinary Diagnostics Diagnostic products for veterinary applications, including species-specific ELISA kits for animal health testing.
- Custom Assay Development Services End-to-end assay development services for ELISA, Chemiluminescent ELISA, and molecular platforms. Supports RUO, LDT, and FDA PMA/510(k) pathways with validation studies including sensitivity, specificity, precision, and linearity.
- Reagent Preparation Services cGMP-compliant manufacturing of buffers and reagents with full traceability and supply chain management. Produces in vitro diagnostic controls, custom serums and matrices for calibrators and controls on an OEM basis.
- Microplate Coating Services Microplate coating services for antigens, antibodies, and capture molecules supporting ELISA, CLIA, and multiplex formats. Offers high throughput (up to 1,000 plates/hour) with lot-to-lot correlation (CV <2%).
- Contract Manufacturing Services End-to-end IVD production including ELISA, CLIA, lateral flow, and molecular formats with scalable batch sizes and QC oversight under ISO/FDA-compliant systems.
- Dispensing, Labeling and Packaging Services Contract manufacturing services for dispensing, capping, and labeling in various vial and bottle formats from 0.25uL to 10L.
- Kitting and Fulfillment Services Full kitting services from label design and component assembly to packaging and global fulfillment for RUO kits, LDT supplies, and IVD products.
Quantifiable outcome
- Over $500,000 in annual savings from tariffs for one global IVD partner
- +3 more outcomes
Companies that use Calbiotech
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles4 records
Calbiotech technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Calbiotech partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Ignite BiomedicalcoreCalbiotech partnered with Ignite Biomedical for the development of diagnostic assays for Autism Spectrum Disorder (ASD). Ignite Biomedical and Liquid Biosciences discovered mRNA biomarkers with greater than 90% sensitivity and specificity for ASD detection. Calbiotech is providing manufacturing capabilities for the diagnostic assay development. The partnership addresses a significant unmet medical need as there are currently no FDA-approved drug products for the direct treatment of autism.
Scale indicators7 records
Recent moves5 records
Expansion highlights5 records
Calbiotech competitors and assessment
Company assessmentDirect peers
- Euroimmun (Revvity): Euroimmun specializes in autoimmune diagnostics and immunoassay development, manufacturing ELISA kits and reagents for global IVD customers. Direct competitor to Calbiotech's Immunovision sub-brand and core autoimmune/ELISA franchise.
- Surmodics (acquired by Roche): Surmodics' Diagnostics Division provides IVD reagent manufacturing, microplate coating, and OEM contract manufacturing services to diagnostic companies. Direct peer to Calbiotech in ELISA/immunoassay reagent and microplate contract manufacturing.
- GenScript: GenScript provides custom protein/antibody services, IVD reagent manufacturing, and CDMO capabilities for diagnostic and biotech customers. Comparable CDMO business model and immunoassay-adjacent service offerings to Calbiotech.
- Medix Biochemica: Medix Biochemica specializes in IVD antibody manufacturing and custom monoclonal antibody development for diagnostic companies. Direct peer to Calbiotech in the IVD antibody and reagent CDMO space, particularly for immunoassay-grade reagents.
- Meridian Bioscience (now part of Revvity): Meridian Bioscience is a leading IVD CDMO serving global diagnostic companies with custom assay development, reagents, and contract manufacturing. Highly comparable to Calbiotech as a direct competitor in immunoassay and ELISA kit CDMO services for IVD manufacturers.
- Binding Site (Thermo Fisher Scientific): Binding Site specializes in immunoassay development for autoimmune and specialty protein diagnostics, with manufacturing capabilities for IVD reagents. Direct competitor to Calbiotech's Immunovision autoimmune franchise and custom assay development services.
Regional players
- Alfa Wassermann Diagnostic Technologies: Alfa Wassermann Diagnostic Technologies provides OEM/contract manufacturing for clinical chemistry and immunoassay reagents. Comparable CDMO model to Calbiotech but with greater focus on clinical chemistry rather than immunoassay-specific platforms.
Broad incumbents
- Bio-Rad Laboratories: Bio-Rad is a large diversified life science and clinical diagnostics company with extensive IVD reagent manufacturing, ELISA kits, and quality control products. Comparable to Calbiotech as a major IVD reagent supplier but at much larger scale and broader portfolio.
- Bio-Techne: Bio-Techne manufactures proteins, antibodies, ELISA kits, and immunoassay reagents for research and diagnostic markets. Overlaps with Calbiotech's Research ELISA Kits and Immunovision product lines, though Bio-Techne is significantly larger and broader in scope.
Emerging players
- ABclonal Technology: ABclonal provides custom antibody generation, IVD reagent development, and ELISA kit manufacturing services. Comparable emerging CDMO with similar immunoassay focus, though with primary roots in research reagents rather than full IVD regulatory CDMO.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Calbiotech social profiles
Digital presenceCalbiotech compliance and trust
Trust signalCompliance2 records
Calbiotech financial estimates
Financial estimateRevenue estimate
Valuation estimate
Calbiotech leadership team
Management profileNumber of profiles
Profiles2 records
Calbiotech funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Calbiotech 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 Calbiotech
What does Calbiotech do?
Calbiotech is a CDMO (Contract Development and Manufacturing Organization) specializing in immunoassay development and manufacturing. It sells catalog ELISA kits, reagents, antigens/antibodies, and laboratory equipment, and provides custom assay development, contract manufacturing, reagent preparation, microplate coating, and kitting/fulfillment services to IVD manufacturers, pharmaceutical firms, and biotech companies from its FDA-registered, ISO 13485:2016-certified facility in El Cajon, California.
Is Calbiotech a public or private company?
Calbiotech is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Calbiotech founded?
Calbiotech was founded in 1998. It employs 11 to 50 people.
Where is Calbiotech based?
Calbiotech is headquartered in El Cajon, United States, in the North America region.
How does Calbiotech make money?
Five revenue lines are on record. Contract Manufacturing Services are the primary driver. The others are ELISA Kits and Research Products, custom Reagent Manufacturing, microplate Coating Services and moduline Systems Products.
Who are Calbiotech's main competitors?
Direct peers on record are Euroimmun (Revvity), Surmodics (acquired by Roche), GenScript, Medix Biochemica, Meridian Bioscience (now part of Revvity) and Binding Site (Thermo Fisher Scientific). Alfa Wassermann Diagnostic Technologies is listed as a regional player. Broad incumbents are Bio-Rad Laboratories and Bio-Techne. ABclonal Technology is listed as an emerging player.
Does Calbiotech have an API?
No public API is recorded for Calbiotech.
What industry is Calbiotech in?
Calbiotech's product category is Contract Diagnostic Manufacturing (CDMO). Its primary akta.pro industry code is HLAGABAG, Drug Substance–Drug Product Integrated CDMO, with a secondary code of HLAGABAH, Sterile Fill-Finish & Aseptic Manufacturing CDMO. Its NAICS code is 325413 and its SIC code is 2835.