After final FDA approval of a new drug, large-scale manufacture can begin. Pharmaceutical manufacturing requires continual monitoring of all aspects of the process: raw ingredients, manufacture, packaging, and storage. Each jurisdiction has codified good manufacturing practices (GMPs), specifying the workflow, record-keeping, and quality requirements for the manufacturing process. The particular drug and the specific manufacturing processes determine the type and number of tests carried out by quality control (QC) laboratories. Show more
Production runs must be routinely monitored for many factors. This so-called release testing can include identification and assay of active substance(s) and excipients, purity assays including measurement of breakdown products and contaminants, and appropriate pharmacological testing such as dissolution. The advent of biopharmaceuticals (biologics or biologicals) and the use of expression systems necessitate the identification and measurement of any residual host cell protein (HCP) or host cell DNA (HCD) in the product. To ensure the safety of the finished product, the target level for residual host cell protein in a drug substance is set at 100 ng/mg or less and 100 pg or less for residual host cell DNA. Show less
Featured ArticleddPCR™ Supermix for Residual DNA Quantification — with comparison to other ddPCR technologies or other methods for doing HCD
Detect and quantitate nucleic acids in your biologicals including any residual host cell DNA. Choose ddPCR™ Assays when you require high sensitivity and tolerance to inhibitors.
Droplet Digital™ PCR Systems ddPCR Supermixes for Residual DNA Quantification
Bio-Rad provides a wide selection of chromatography resins (media) available in custom volumes and packaging to meet the specific purification requirements for your biopharmaceutical process.
Ion Exchange Resins Affinity Resins Mixed-Mode Resins Chromatogtaphy Resin Screening Tools
Streamline your protein analysis with our comprehensive protein analysis tools. Validate antibodies used to detect and identify contaminating host cell proteins (HCP).
Western Blotting Reagents and Equipment Validated Western Blotting Antibodies GS-900™ Calibrated Densitometer and Regulatory Tools (CFR validated for cGMP) Antibody Validation for Host Cell Protein (HCP) ELISAs
Choose from a comprehensive selection of antibodies or explore our custom antibody services for specific antibody requirements
Antibodies by Application Antibodies by Target Species HuCAL® Custom Antibody Services
Biomarker DiscoveryThe use of biomarkers across drug discovery and development and into the clinic is key to enabling close monitoring of a drug candidate’s effects. Biomarkers can range from specific molecules such as a protein, a gene sequence, or expressed RNA to physiological parameters such as blood pressure. Biomarkers may be detected in a specific location or tissue or in plasma and other bodily fluids.
Biochemical and Cellular AssaysBiochemical and cellular pharmacology teams develop and validate assays to support research across drug discovery and development. These assays range from discovery approaches with high sample throughput to high-content analysis to gain an understanding of biological response both in vitro and in vivo.
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