Calbiotech
Private Company
Funding information not available
Overview
Calbiotech is an established, privately-held CDMO and diagnostics provider founded in 1998 and headquartered in Spring Valley, California. The company leverages over 25 years of expertise to offer custom assay development, contract manufacturing, and reagent formulation services, primarily for the IVD sector, supported by FDA registration and ISO 13485 certification. Its dual business model combines fee-for-service CDMO work for biotech and pharma clients with a direct product business selling validated ELISA kits for research and preclinical applications. Calbiotech's strategic position is strengthened by its U.S. manufacturing base, which aids partners in navigating regulatory pathways and accessing the American market.
Technology Platform
Immunoassay (ELISA/CLIA) and molecular diagnostic (multiplex PCR) development and manufacturing platform, supported by ISO 13485-certified, FDA-registered quality systems for IVD commercialization.
Opportunities
Risk Factors
Competitive Landscape
Competes with large, diversified CDMOs like Thermo Fisher Scientific and Charles River Laboratories, as well as specialized diagnostic CROs/CDMOs. Differentiation is based on its mid-size flexibility, deep immunoassay expertise, and strategic value as a U.S.-based, FDA-registered manufacturing partner for market access.