BBI Solutions

Beta-2 Microglobulin (B2M) is widely used in immunoassays supporting oncology, nephrology, and other clinical applications. BBI's recombinant human B2M is expressed in Pichia pastoris and manufactured under an ISO 13485-certified quality management system. Designed for IVD manufacturers, the antigen provides: >98% purity by SDS-PAGE analysis Donor-independent production Batch-to-batch consistency Manufacturing from mg to gram scale Suitable for use as a calibrator or control material across a range of immunoassay applications.

Many Beta-2 Microglobulin assays continue to rely on donor-derived material. While native B2M remains well established, donor-dependent sourcing can introduce challenges around availability, scalability, and long-term supply planning. BBI’s Recombinant B2M offers an alternative approach- a scalable, donor-independent antigen suitable for both assay development and routine commercial manufacture. As demand continues to grow across oncology and nephrology testing, secure supply is becoming just as important as analytical performance.

Beta-2 Microglobulin (B2M) is widely used in immunoassays across oncology, nephrology, and other clinical applications. BBI’s recombinant human B2M is expressed in Pichia pastoris and manufactured under an ISO 13485-certified quality system, offering >98% purity, donor-independent production, batch-to-batch consistency, and scalable mg-to-gram manufacturing. Learn how recombinant B2M can support your assay requirements.

For manufacturers considering a move from native to recombinant Beta-2 Microglobulin (B2M), analytical performance remains the key consideration. BBI has evaluated multiple production lots of recombinant B2M against native material, assessed across multiple immunoassay platforms, supporting confidence during assay development and validation activities. The objective is simple: provide a recombinant alternative that closely matches native performance while delivering the benefits of scalable manufacturing and donor-independent supply.

Transitioning from native to recombinant materials requires confidence in both product performance and supplier capability. BBI supports assay developers and manufacturers throughout the development process with: Technical data packages Product samples Application support Manufacturing and quality documentation Long-term supply discussions Whether you are qualifying a secondary source, addressing supply challenges, or evaluating recombinant alternatives for future development, our team can help. Get in touch today to discuss your application.

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