In-vitro diagnostics or IVD refers to medical devices and tests that are performed on samples like blood or tissue that have been taken from the human body. These diagnostic tests help detect infections, evaluate chronic diseases and screen for various health conditions. All IVD products require raw materials to manufacture test kits, reagents, instruments and other components used in testing. This article provides an overview of some key raw materials used in IVD manufacturing.
Antibodies
Antibodies are protein molecules produced by the immune system that recognize specific antigens or structures on pathogens or diseased cells. In IVD testing, antibodies play a critical role in immunoassays which detect the presence or concentration of targeted analytes. Monoclonal antibodies offer high specificity and reproducibility which is useful in clinical diagnostics. Key sources of antibodies for include mouse, rabbit and goat. Top antibody suppliers provide custom monoclonal antibody development services to diagnostics companies.
Enzymes
Enzymes are protein-based biochemical catalysts that enable or accelerate specific chemical reactions. Many diagnostic assays rely on enzymes to recognize target analytes and generate signals or color change reactions. Commonly used enzymes in diagnostics include horseradish peroxidase (HRP), alkaline phosphatase (AP), beta-galactosidase and glucose oxidase. Natural or recombinant sources of enzymes allow standardization and large-scale manufacturing of IVD test kits. Stability and activity of enzymes during storage is an important quality parameter.
Biological Buffers
IVD Raw Materials Biological buffers help maintain the pH of diagnostic reagents close to physiological conditions which is essential for optimal performance of assays involving enzymatic reactions or immunoassays. Common buffer systems used in IVD include phosphate buffered saline (PBS), Tris-buffered saline (TBS) and 2-ethanesulfonic acid (HEPES) buffers. Key considerations while selecting buffers include buffering capacity, pH range, compatibility with assay components and minimal interference in testing.
Biological Ligands
Biological ligands refer to molecules that bind specifically to other molecules like antigens or receptors. In diagnostics, specific ligands are used to capture target analytes. Common biological ligands used in IVD include antibodies, aptamers, cytokines, growth factors and cell adhesion molecules. Purified ligands with high affinity and specificity are integral to developing sensitive immunoassays and molecular diagnostic tests.
Control Materials
Control materials of known composition are essential for quality control, calibration, performance testing and assurance of diagnostic assays and instruments. Common types of control materials used in IVD include purified proteins, recombinant proteins, serum or plasma based materials, whole blood or cell-line based controls. Stability, commutability, traceability to reference standards are important characteristics of control materials. Developers work closely with control material suppliers to validate performance with their testing systems.
Raw Material Quality Management
Due to regulatory requirements and direct impact on testing performance, quality management of raw materials is critical in IVD Raw Materials Suppliers are qualified based on their quality systems, certifications, documentation and manufacturing controls. Key quality attributes evaluated include purity, activity, specificity, stability and freedom from contaminants. Raw material testing is performed to ensure specifications are met. Traceability, proper storage and distribution systems also help maintain quality and compliance. Comprehensive raw material management enables reliable, robust and reproducible IVD product development and manufacturing.
Emerging Raw Material Technologies
Novel technologies are expanding raw material options for diagnostic developers. Recombinant enzymes, antibodies and ligands offer consistency and scale-up capabilities compared to traditional production methods. Aptamers selected through Systematic Evolution of Ligands by EXponential enrichment (SELEX) provide specific molecular recognition elements alternative to antibodies. Nanoparticles offer increased surface area for immobilizing biomolecules or building assay architectures with improved sensitivity. Advances in biomanufacturing and synthetic biology can accelerate development and industrialization of emerging IVD raw material technologies.