What SDIX does

SDIX, LLC is a U.S.-based biotechnology and contract manufacturing company specializing in high-quality, large-scale GMP antibody production for the in vitro diagnostics (IVD), anatomic pathology, biotechnology, and pharmaceutical markets. Operating from Newark, Delaware and Windham, Maine, the company is a wholly owned subsidiary of OriGene Technologies (acquired July 2013) and traces its origins to SDI Inc. founded in 1990. SDIX organizes its offering around three integrated pillars: IHC antibodies (UltraMAB and TrueMAB CE-marked diagnostic immunohistochemistry reagents covering oncology, immune cell, and tissue markers), IVD reagents (polyclonal and monoclonal antibodies, calibrators, and controls for clinical chemistry, immunology, infectious disease, and cardiac markers including Troponin I and the newly launched Lp(a) reagent), and contract manufacturing services spanning cell line optimization, in vivo ascites and in vitro roller bottle monoclonal production, dual-site cell banking, Protein A/G purification, fragmentation, conjugation, and large-scale polyclonal production across rabbit, goat, sheep, chicken, and small species.

The underlying technology stack centers on the proprietary Genomic Antibody Technology (GAT) introduced in 2006, UltraMAB monospecific screening on protein array chips, in-house cell line optimization targeting >85% clonality via limited dilution cloning, automated plasmapheresis for polyclonal antisera collection (up to 30 liters per goat/sheep annually), and an integrated bioprocessing workflow. Physical capacity includes a new 15,000 sq ft GMP vivarium housing 60,000+ mice and a 143.6-acre polyclonal campus with 14 buildings, 8 species, and 16,000-animal capacity. All sites hold ISO 13485:2016 certification (since March 2018), with USDA/APHIS export licensing to the EU, AAALAC accreditation since 2000, OLAW assurance, and DEA registration.

SDIX monetizes through a mix of one-time catalog IVD reagent sales, fee-for-service contract manufacturing, recurring OEM/white-label production run against client Master Batch Records, and managed-services vendor agreements with monthly/yearly contracts and dock-to-stock inventory. Pricing is quote-based and not publicly disclosed; free samples are offered via the website and direct email. The customer base is concentrated among large enterprise buyers — specifically all of the top IVD companies, 14 of the top 20 pharmaceutical and biotechnology companies, and 3 of the top 5 antibody reagent suppliers — with a sales motion that combines field/enterprise sales, inside sales, e-commerce-style catalog ordering, industry events (ADLM), and direct OEM partnerships.

Name

SDIX

Legal name

SDIX, LLC

Website

https://sdix.com

Company type

Private

Founded year

1990

Operating status

Operating

Headcount range

51–100 employees

Short description

SDIX, LLC is a U.S. contract antibody manufacturer and IVD reagent supplier serving IVD, anatomic pathology, biotech, and pharmaceutical customers with GMP monoclonal and polyclonal antibody production from Delaware and Maine facilities, operating as a wholly owned subsidiary of OriGene Technologies.

Ownership category

akta.pro rank

Headquarters

HQ city

Newark

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Supply Chain, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Catalog IVD Reagent and IHC Antibody Product Sales: One-time sales of catalog antibodies, calibrators, and controls (Troponin I, Strep A, CRP, Apo A1, ApoB, Micro-albumin, AGP, ALB, C3, C4, CER, HPT, IgA, IgE, IgG, IgG-Fc, IgM, TRF, Red Blood Cells ABO, Lp(a), etc.) used by IVD manufacturers and anatomic pathology labs. Includes product codes, grades (TIA Antiserum, IgG fraction, Affinity Purified), and bulk/conjugated/match-paired reagent options.
2. Contract Manufacturing Services (OEM Antibody Production): Fee-for-service large-scale GMP contract manufacturing of monoclonal (in vivo ascites and in vitro roller bottle) and polyclonal antibodies for IVD, biotech, and pharmaceutical customers. Includes cell line optimization, cell banking, bioprocessing, purification, and conjugation. Leverages 30+ years of OEM antibody production experience and economies of scale.
3. Custom Formulation, Blending, and Vendor Management for IVD Clients: Custom reagent formulation and blending services (considering low-end sensitivity, linearity/slope, dynamic range, prozone) plus dock-to-stock inventory management and ongoing supply agreements. Recurring component via monthly/yearly contract agreements.
4. OEM/White-label Antibody Manufacturing for IVD Companies: OEM antibody production where SDIX manufactures reagents on behalf of IVD companies under the client's Master Batch Records, enabling partners to bring new assays to market faster while leveraging SDIX's bulk production and inventory management capabilities.

Pricing tiers

Go-to-market motion4 records

Distribution channels5 records

Marketing channels5 records

Core offering

SDIX develops, manufactures, and supplies high-quality antibody-based reagents and OEM contract manufacturing services for the in-vitro diagnostics (IVD), anatomic pathology, biotechnology, and pharmaceutical markets. Its offerings span catalog IHC antibodies (UltraMAB and TrueMAB), bulk and custom IVD antibodies/calibrators/controls (Troponin I, CRP, IgG, etc.), and large-scale GMP monoclonal (in vivo ascites and in vitro roller bottle) and polyclonal antibody production services including cell line optimization, dual-site cell banking, bioprocessing (Protein A/G purification, fragmentation, conjugation), and ongoing vendor-managed supply.

Product overview

SDIX, LLC is a wholly owned subsidiary of OriGene Technologies operating as a biotechnology and immuno-solutions company with a portfolio-plus-services architecture organized around three integrated pillars: (1) IHC Antibodies (UltraMAB and TrueMAB CE-marked diagnostic immunohistochemistry reagents covering markers such as ALK, AFP, AMACR, Annexin A1, ARG1, Beta-Catenin, CD19, CD2, CD20, CD23, CD31, CD4, CD5, CD56, CD68, CK8, CK18, CK20, E-Cadherin, EGFR, EMA, EPCAM, ERCC1, ERG, GFAP, HER2, Ki-67, MART1, N-Cadherin, P53, PAX5, PD-1, S100P, SYP, Top2A, and Vimentin); (2) IVD Reagents (polyclonal and monoclonal antibodies, calibrators, and controls covering plasma proteins, immunoglobulins, complement, infectious disease antigens such as AGP, ALB, Apo-A1, Apo-B, C3, C4, CER, CRP, Cystatin C, HPT, IgA, IgE, IgG, IgG-Fc, IgM, Lp(a), NT-proBNP, Red Blood Cells, sCD14, Strep-A, Strep-B, TRF, TSH, and Troponin I, plus Calibrators 0-7); and (3) Contract Manufacturing services for monoclonal antibodies (cell line optimization, in vivo ascites production, in vitro roller bottle production, dual-site cell banking, Protein A/G purification, fragmentation, and conjugation) and polyclonal antibodies (immunization protocols across rabbit, goat, sheep, chicken, and small species, bioprocessing, automated plasmapheresis, and inventory management). All products are manufactured in cGMP, ISO 13485:2016-certified facilities in Newark, Delaware and Windham, Maine, with the UltraMAB IHC product line manufactured under a partnership with OriGene.

Differentiator

Problem solved

Functional benefit

Products and services

• IHC Antibodies (UltraMAB) OriGene UltraMAB and TrueMAB monoclonal antibodies manufactured by SDIX in a GMP environment, systematically screened on protein array chips for monospecificity, intended for detection of specific protein expression in frozen or formalin fixed human tissues and cells, and CE-marked for the European market.
• IVD Reagents (Antibodies, Calibrators, and Controls) Bulk and custom IVD antibodies, calibrators, and controls covering plasma proteins, immunoglobulins, complement, infectious disease antigens, and cardiac markers (Troponin I, CRP, Apo-A1, Apo-B, C3, C4, CER, AGP, ALB, IgA, IgE, IgG, IgG-Fc, IgM, Red Blood Cells, Strep-A, Strep-B, TRF, Cystatin C, NT-proBNP, sCD14, TSH, Micro-albumin, HPT, Lp(a)), with 30+ years of antibody expertise and large-scale bulk production capabilities for IVD manufacturers.
• Contract Manufacturing (Monoclonal and Polyclonal Antibody Production) Large-scale, customized, GMP-compliant antibody contract manufacturing services including cell line optimization, in vivo (ascites) and in vitro (roller bottle) monoclonal antibody production, dual-site cell banking/storage, bioprocessing (Protein A/G purification, fragmentation, conjugation), and large-scale polyclonal antibody production across multiple species. Built on 30+ years of OEM antibody production experience.
• Monoclonal Antibody to Lp(a) Newly launched monoclonal antibody targeting lipoprotein(a) (Lp(a)) for IVD applications, available for sample order from SDIX.
• Sensitive Troponin I Antibody Pair (TPC110 + 10C9) Matched-pair antibody set for sensitive cardiac Troponin I detection, comprising clones TPC110 (epitope 24-40) and 10C9 (epitope 41-60), for IVD cardiac diagnostics manufacturers.
• Custom Formulation and Blending of IVD Reagents Custom IVD reagent blending and formulation service adjusting for low-end sensitivity, linearity/slope, dynamic range, and prozone to meet specific client platform requirements, with ongoing match-titer consistency for established products.
• Vendor Management Service for IVD Reagents Supply chain and inventory management service for IVD reagents offering dock-to-stock inventory, monthly/yearly contracts, in-house QC testing, GMP and ISO 13485:2016 regulatory compliance, and bulk/conjugated/match-paired reagent supply.
• Monoclonal Cell Line Optimization Pre-production verification of customer-supplied hybridoma cell lines including biological safety testing (Impact I / Impact IV), viability recovery, clonality testing, and subcloning to maximize antibody yield, with a 4-step process targeting >85% clonality for lower cost per milligram.
• Large Scale Monoclonal Antibody Production (In Vivo and In Vitro) GMP-compliant ascites (in vivo) and roller bottle (in vitro) monoclonal antibody production at scales from 50 to 2,000 mice per lot and 5-100L per batch, with optional media optimization including serum-free and animal protein-free formulations.
• Dual-Site Cell Storage and Banking Cryogenic cell banking and storage services including Platinum and Gold Master Cell Banks, Research Cell Banks, and Manufacturer's Working Cell Banks, with dual-site storage at -150°C or less across Delaware and Maine.
• Monoclonal Bioprocessing (Protein A/G Purification, Fragmentation, Conjugation) Monoclonal antibody downstream processing services including Protein A and Protein G purification from ascites and supernatant, Papain-F(ab) and Pepsin-F(ab')2 fragmentation, and conjugation to enzymes, fluorescence, latex, and magnetic particles for downstream diagnostic assay integration.
• Large Scale cGMP Polyclonal Antibody Production Over 30 years of polyclonal antibody production expertise, supplying high-quality polyclonal reagents to IVD companies globally, including immunogen and protocol selection, animal colony management, purification/bioprocessing, custom formulation, and inventory management across multiple host species.
• Polyclonal Bioprocessing Polyclonal antibody laboratory services including single pass or full depletion affinity purification, ELISA screening, antigen conjugation, Protein A/G purification, defibrination, delipidation, caprylic acid / sodium sulfate / ammonium sulfate IgG cuts, IgY isolations, and antibody pooling/vialing.
• Species-Specific Immunization Protocols (Rabbit, Goat, Sheep, Chicken) Standardized immunization protocols for antibody production across multiple host species, including 70-day rabbit, 200-day goat/sheep, and 59- and 79-day chicken protocols, plus mice, rats, hamsters, and guinea pigs on request, supporting polyclonal reagent production for IVD manufacturers.

Quantifiable outcome

• SDIX's mean antibody yield from ascites production is 18.9 mgs of antibody per mouse (range from <1 mg to over 50 mgs depending on cell line).
• +4 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Six partnerships are on record, tiered flagship (parent company), minor (historical), core (industry coverage) and minor (historical food-safety business).

• OriGene Technologies, Inc.flagship (parent company)Strategic or Co-development Partner · 1 July 2013In July 2013, OriGene Technologies acquired SDIX's Life Science assets. SDIX, LLC now operates as a wholly owned subsidiary of OriGene Technologies, combining SDIX's core Life Science business and Advanced GAT technologies with OriGene's genome-wide research tools and technology platform to deliver an expanded product portfolio. OriGene UltraMAB and TrueMAB antibodies are manufactured at SDIX in a GMP environment.
• MD Anderson Cancer Centerminor (historical)Strategic or Co-development Partner · 1 January 2007In 2007, SDI (now SDIX) collaborated with MD Anderson Cancer Center in the search for breast cancer biomarkers, applying SDIX's immuno-solutions and antibody-based assay development expertise to academic cancer research.
• Top IVD companies (industry-wide)core (industry coverage)OEM/ Whitelabel/ Licensing PartnerSDIX has longstanding OEM/custom-manufacturing partnerships with all of the top IVD companies, supplying GMP-manufactured antibodies, calibrators, and IVD reagents used in their diagnostic platforms. Custom solutions are delivered per the client's Master Batch Records.
• 14 of the top 20 Pharmaceutical and Biotech companiescore (industry coverage)Strategic or Co-development PartnerSDIX has delivered diagnostic, research, and discovery solutions for partners including 14 of the top 20 pharmaceutical and biotech companies, applying SDIX's custom, applications-driven immuno-solutions to R&D and commercialization goals.
• 3 of the top 5 antibody reagent supplierscore (industry coverage)OEM/ Whitelabel/ Licensing PartnerSDIX supplies antibody products and OEM manufacturing services to 3 of the top 5 antibody reagent suppliers, leveraging its GMP production capabilities and 30+ years of antibody development experience.
• Most of the major food producers, processors, and marketersminor (historical food-safety business)Channel Partner/ Reseller/ DistributorHistorical partnerships with major food industry players for food-safety testing, including the patented RapidChek SELECT Salmonella bacteriophage-based media (launched 2003). SDIX's focus has since shifted to life sciences and IVD.

Scale indicators8 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• OriGene Technologies: Parent company of SDIX; provides genome-wide research tools, overexpression lysates, and UltraMAB/TrueMAB antibody products manufactured at SDIX. While parent-subsidiary rather than pure competitor, OriGene sells overlapping IHC and research antibody products through its own channels.
• Rockland Immunochemicals: Custom antibody manufacturer and IVD/research reagent supplier with polyclonal and monoclonal production capabilities. Closely comparable to SDIX in custom reagent services, OEM antibody manufacturing, and IVD-grade reagent production.
• Abcam: Leading research antibody supplier with a large catalog of IHC, ELISA, and Western blot reagents. Comparable to SDIX in the IHC antibody and IVD reagent space, though more focused on catalog research tools versus OEM contract manufacturing.
• GenScript: Global contract research organization offering custom antibody production, recombinant protein services, and IVD/OEM reagent manufacturing. Directly comparable to SDIX in custom polyclonal and monoclonal antibody contract manufacturing for diagnostic and biotech customers.
• Cell Signaling Technology: Specialized antibody manufacturer focused on high-quality, application-validated antibodies for research and clinical diagnostics, including IHC. Comparable to SDIX's UltraMAB/TrueMAB positioning in the IHC and diagnostics reagent market.

Broad incumbents

• Merck KGaA / MilliporeSigma: Large life sciences supplier offering catalog antibodies, OEM bioreagent production, and bioprocessing services through the Sigma-Aldrich/MilliporeSigma brand. Overlaps with SDIX in IVD-grade antibody supply but operates a much broader life sciences portfolio.
• Bio-Rad Laboratories: Large life science tools and clinical diagnostics company with a significant antibody, reagent, and OEM contract manufacturing business. Overlaps with SDIX in IVD reagent supply and protein purification, but operates at much larger scale across a broader portfolio.
• Thermo Fisher Scientific: Global life sciences and diagnostics conglomerate with antibody production, OEM manufacturing, and IVD reagent capabilities (through brands such as Invitrogen, Pierce, and Patheon). Comparable to SDIX in serving IVD and pharma/biotech customers, but vastly broader in scale and product range.

Emerging players

• Fitzgerald Industries International: Specialty antibody and reagent manufacturer focused on IVD and clinical diagnostics customers with polyclonal and monoclonal capabilities. Comparable niche scale and customer overlap with SDIX, particularly in clinical chemistry and immunology IVD reagents.
• Capra Science: Specialized Swedish polyclonal antibody contract manufacturer using rabbits, goats, and other species, with a focus on custom antisera production for diagnostic and research use. Comparable to SDIX's polyclonal production services but operating primarily in Europe.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/thesdix
• LinkedInlinkedin.com/company/strategic-diagnostics

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SDIX