Calbiotech’s development, quality, and manufacturing teams support programs from early assay development through regulated production and commercial supply. Our multidisciplinary teams operate within established quality system environments supporting technology transfer, scale-up manufacturing, and long-term partner supply programs.

Calbiotech operates under established quality system frameworks aligned to FDA Quality System Regulation, ISO 13485 requirements, and current Good Manufacturing Practices (cGMP). Our quality and manufacturing systems support development, transfer, and production of immunoassay and related diagnostic technologies for research, laboratory, and commercial assay programs.

Calbiotech supports diagnostic companies, laboratory networks, and regional partners across North America, Latin America, Middle East, and Asia through development partnerships, manufacturing programs, technology transfer supporting regional production implementation, and localized commercialization strategies.

Calbiotech maintains integrated development, manufacturing, and quality system infrastructure designed to support long-term diagnostic production programs and global partner supply requirements.

Our manufacturing operations support controlled production environments, validated processes, and scalable manufacturing workflows designed to support transition from development through sustained commercial production.