Sex Hormone Binding Globulin – SHBG
Sex Hormone Binding Globulin (SHBG)
Sex hormone binding globulin (SHBG) is a key transport glycoprotein that regulates bioavailable testosterone and estradiol, making it central to endocrinology and fertility testing.
BBI’s complete SHBG portfolio for IVD manufacturers, spanning native and recombinant antigens to support endocrinology and fertility testing, immunoassay development, and control manufacture.
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Securing Long-Term SHBG Assay Performance
For manufacturers, SHBG antigens must be consistent, well characterised and available at scale to support long-term assay standardisation and regulatory submissions.
BBI Solutions offers a complete portfolio of SHBG antigens for assay developers and IVD manufacturers, including proven native plasma derived antigens and a new CHO derived recombinant antigen, designed to secure long-term assay performance and supply.
BBI's SHBG Portfolio
| Product Name | Code | Type | Applications | |
|---|---|---|---|---|
| Sex Hormone Binding Globulin (Recombinant) | P145-6 | Antigens/Proteins | Biosensor, Clinical Chemistry, Control Manufacture, ELISA, Life Sciences | Buy now |
| Sex Hormone Binding Globulin > 90% | P145-5 | Antigens/Proteins | Biosensor, Clinical Chemistry, Control Manufacture, ELISA, Life Sciences | Buy now |
| Sex Hormone Binding Globulin > 40% | P145-4 | Antigens/Proteins | Biosensor, Clinical Chemistry, Control Manufacture, ELISA, Life Sciences | Buy now |
All SHBG products are manufactured under BBI’s ISO 13485‑certified Quality Management System with robust QC, including bioburden control and platform‑based characterization where relevant.
What is Sex Hormone Binding Globulin?
Sex hormone binding globulin (SHBG) is a key transport glycoprotein that regulates bioavailable testosterone and estradiol, making it central to endocrinology and fertility testing. Abnormal SHBG levels are associated with androgen excess or deficiency, metabolic syndrome, thyroid disease, liver dysfunction and hormone‑related cancers, driving growing demand for reliable SHBG measurement in clinical laboratories
Why SHBG matters in endocrinology assays
Regulates the balance between bound and free sex steroids, directly influencing free testosterone and estradiol calculations used in male hypogonadism and polycystic ovary syndrome (PCOS) workups.
Clinically requested in panels investigating infertility, puberty disorders, androgen excess, and thyroid or liver dysfunction.
Emerging evidence links SHBG concentrations to cardiometabolic risk and type 2 diabetes, increasing its value in broader risk-stratification panels.
Why partner with BBI for SHBG?
BBI has supplied native SHBG to leading global diagnostic companies for many years and now extends that expertise to recombinant SHBG
Access native and recombinant SHBG from one supplier, enabling dual sourcing strategies, lifecycle planning and portfolio evolution without fragmenting your supply base
Our technical teams can advise on assay integration, platform behaviour and, where required, tailored fills or product customisation to match your development needs
New Recombinant SHBG
BBI has expanded its market-leading SHBG range with a CHO cell-expressed, lyophilised recombinant antigen (P145‑6) designed for IVD manufacturers developing or maintaining SHBG calibrators and control materials in endocrinology and fertility testing.
P145-6 is a recombinant human SHBG expressed in CHO cells, offering a consistent, donor‑independent alternative to serum‑derived material. It has been developed for IVD manufacturers who require secure, long‑term supply for SHBG calibrators, control materials and method development
Key features:
- CHO‑expressed, lyophilised antigen with >80% nominal purity and O‑glycosylation consistent with native SHBG
- Strong immunoassay reactivity, with platform data on Siemens IMMULITE® and Roche cobas® systems supporting use in major SHBG assay formats
- Donor-independent manufacturing with gram-scale capacity reduces raw-material risk and supports both development and commercial production volumes.
Available in 1 mg and 10 mg pack sizes, with gram-level manufacturing capability from our ISO 13485-certified UK facility, P145‑6 is designed to support everything from feasibility through to routine production
Native SHBG
BBI’s native SHBG range is purified from normal human serum/plasma at our HTA-approved site, with over 25 years’ experience in sourcing and characterising human biologicals. These materials are widely used by IVD manufacturers in clinical chemistry, ELISA, biosensors, lateral flow and other immunoassay formats.
Both native products are supplied with CoAs including purity, protein concentration, and infectious disease testing on starting material using FDA approved assays, supporting use in calibrators, controls and reference materials.
BBI’s SHBG Portfolio
| Product Name | Code | Type | Applications | |
|---|---|---|---|---|
| Sex Hormone Binding Globulin (Recombinant) | P145-6 | Antigens/Proteins | Biosensor, Clinical Chemistry, Control Manufacture, ELISA, Life Sciences | Buy now |
| Sex Hormone Binding Globulin > 90% | P145-5 | Antigens/Proteins | Biosensor, Clinical Chemistry, Control Manufacture, ELISA, Life Sciences | Buy now |
| Sex Hormone Binding Globulin > 40% | P145-4 | Antigens/Proteins | Biosensor, Clinical Chemistry, Control Manufacture, ELISA, Life Sciences | Buy now |
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