Maxim Biomedical, Inc.
Manufacturer and contract developer of in vitro diagnostic kits and immunoreagents based in Rockville, Maryland. Offers assay development and OEM kit manufacturing under a quality system that includes FDA cGMP compliance and ISO 13485 certification. Operates a 30,000 sq. ft. facility with clean rooms, BSL-3 capability, automated filling and plate-coating equipment, and provides services from recombinant antigen/antibody production to kit assembly, packaging and contract manufacturing for infectious disease diagnostics.
Industries
N/A
Products
Urine-based HIV-1 antibody enzyme immunoassay (EIA)
Urine-based EIA for detection of HIV-1 antibodies for use in professional laboratory settings (screening assay).
Serum/plasma Western blot confirmatory assays
Serum/plasma immunoblot assays intended for confirmatory testing of samples positive or indeterminate by routine screening.
Limiting-antigen avidity EIA for HIV-1 incidence testing (DBS and serum/plasma)
Avidity-based EIA formats for incidence estimation compatible with dried blood spot (DBS) and serum/plasma specimens; reported CDC approval.
Commercial ELISA and rapid test kits for vector-borne diseases (example: dengue)
Commercially offered ELISA kits and rapid immunochromatographic cassettes for dengue IgG/IgM serology, provided via the company shop/distribution channel.
Urine-based HIV-1 antibody enzyme immunoassay (EIA)
Urine-based EIA for detection of HIV-1 antibodies for use in professional laboratory settings (screening assay).
Serum/plasma Western blot confirmatory assays
Serum/plasma immunoblot assays intended for confirmatory testing of samples positive or indeterminate by routine screening.
Limiting-antigen avidity EIA for HIV-1 incidence testing (DBS and serum/plasma)
Avidity-based EIA formats for incidence estimation compatible with dried blood spot (DBS) and serum/plasma specimens; reported CDC approval.
Commercial ELISA and rapid test kits for vector-borne diseases (example: dengue)
Commercially offered ELISA kits and rapid immunochromatographic cassettes for dengue IgG/IgM serology, provided via the company shop/distribution channel.
Services
Contract manufacturing (CRO/CMO) for diagnostic kits
Manufacture of diagnostic kits to customer specifications in a cGMP facility, including OEM and contract production.
Assay development and validation
Development of immunoassays (ELISA, WB/RIBA, rapid tests, PCR) and support for scale-up and validation to manufacturing.
Reagent production and formulation
In-house recombinant antigen production, antibody production in cell culture, reagent formulation and control manufacture.
Kit assembly, packaging and labeling
Full kit assembly including foil pouching, custom labeling, and packaging tailored to client requirements.
Contract manufacturing (CRO/CMO) for diagnostic kits
Manufacture of diagnostic kits to customer specifications in a cGMP facility, including OEM and contract production.
Assay development and validation
Development of immunoassays (ELISA, WB/RIBA, rapid tests, PCR) and support for scale-up and validation to manufacturing.
Reagent production and formulation
In-house recombinant antigen production, antibody production in cell culture, reagent formulation and control manufacture.
Kit assembly, packaging and labeling
Full kit assembly including foil pouching, custom labeling, and packaging tailored to client requirements.
Expertise Areas
- In vitro diagnostic assay development
- Serology and confirmatory testing
- Contract manufacturing (CRO/CMO) for diagnostics
- Biomanufacturing and reagent production
Key Technologies
- Enzyme-linked immunosorbent assay (ELISA)
- Western blot / immunoblot
- Rapid immunochromatographic (lateral flow) assays
- PCR-based assay workflows