Pharmaceutical Manufacturing and Release Testing




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

Feature Articles

Bio-Rad's Drug Discovery and Development Workflow Solutions
Learn how Bio-Rad's products align with your drug discovery and development workflows  Download

ddPCR™ Supermix for Residual DNA Quantification — with comparison to other ddPCR technologies or other methods for doing HCD

Solutions for Pharmaceutical Manufacturing and Release Testing

Gene Expression

Gene Expression

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

PCR Instrument Validation Tools and Services


Chromatography Resins for Process-Scale Protein Purification

Chromatography Resins for Process-Scale Protein Purification

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

Protein Analysis and Confirmation

Protein Analysis and Confirmation

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

Additional Methodolgies and Research Within Drug Discovery and Development

Biomarker Discovery

Biomarker Discovery
The 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 Assays

Biochemical and Cellular Assays
Biochemical 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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