Calbiotech, Inc.

Calbiotech, Inc. is an FDA-registered, ISO 13485-certified contract development and manufacturing organization (CDMO) specializing in immunoassay development and production for diagnostic and research applications. Based in El Cajon, California, the company brings 25+ years of in-vitro diagnostics (IVD) expertise to support diagnostics innovation from assay design through commercial scale-up. Calbiotech develops and manufactures over 200 ready-to-use ELISA kits covering clinical diagnostics (cardiac markers, diabetes, infectious disease, cancer markers, allergy, autoimmune disorders) and preclinical research (mouse/rat biomarkers, neonatal screening). Core CDMO services include custom assay design and optimization, contract manufacturing with scalable batch sizes, reagent formulation and fill-finish, biomarker validation, regulatory pathway support (LDT, RUO, IVD), and quality/compliance documentation under cGMP standards. The company also manufactures monoclonal antibodies in a dedicated GMP facility. Calbiotech serves a global customer base across 50-80 countries, offering U.S. manufacturing origin, local manufacturing partnerships, and regulatory support for market access.