Pilot Batch Control Serum Production

Production of purified and characterized antibodies with batch-to-batch consistency. Scaling capabilities to 5g support assay standardization and regulatory requirements.

Specialized contract production of custom polyclonal antisera with non-standard specificities in USDA licensed facilities.

Quality control materials for clinical biochemistry testing. Developed with advanced production techniques to ensure product stability and uniformity across test batches.

Full-service custom antibody development from immunization through characterization and production. ISO 13485-certified manufacturing ensures compliance for diagnostic and research applications.

Contract manufacturing services for rapid testing kit assembly with documented quality control processes. Includes assay development and small-batch production with full traceability and SOP-based quality assurance.

Manufacturer-customized quality control sera formulated according to specific laboratory requirements and analyte specifications. Available in liquid form with configurable analyte panels to meet individual diagnostic testing needs. Batch-constant formulations ensure consistency across multiple quality control cycles.

BIOREF manufactures custom-designed liquid control sera with a human serum matrix comparable to patient serum. These ready-to-use controls offer a shelf life of up to 5 years at -20°C and are stable at 4°C for periods ranging from several weeks to multiple years depending on analytes included. Customers can customize analyte content, concentrations (including normal, pathologically high, and low levels), number of levels, filling options (bottles or small vials), and labeling according to their specific needs. The controls can be supplied in liquid form or lyophilized as required.

On-demand custom quality control product design and manufacturing for analytes not in standard stock. Includes full method validation, compliance documentation, and regulatory support for clinical and forensic toxicology laboratories.

Custom manufacturing of diagnostic reagents including antigens, enzymes, and molecular components. ISO 13485 certification and validated processes ensure regulatory compliance.

Quality control materials derived from processed human serum designed for validation and verification of immunoassay and mass spectrometry methodologies. Used to monitor assay performance and accuracy in clinical and research laboratories.

Quality control material for serum protein measurement. Available in 4x1 mL presentation. Reference 1102004.

Private label manufacturing services for biological reagents and diagnostic solutions customized to customer specifications. Manufactured under ISO-aligned quality control with comprehensive traceability documentation.