Process Development and Scale-Up


The required production quantities of a candidate drug molecule increase greatly as the development cycle moves from discovery through development to approval and large-scale manufacturing. Design and optimization of production scale-up (including pilot plant operations), also known as process development, requires careful testing and monitoring using a wide range of different techniques including protein purification, analysis, quantitation, and identification tools at every step. Show more

One field of active research is to determine how small-scale models can be used to both design scale-up procedures and permit more rapid testing and optimization of process development. This is called scale-down, and provides greater flexibility for testing multiple parameters, more rapid system characterization, and iterative improvements. Furthermore, scale-down can be used for validation purposes. In addition to saving time, scale-down can significantly reduce costs. Sensitive analytical techniques are required for accurate evaluation of scale-down. Show less

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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

Ceramic Hydroxyapatite Application Guide for Process Development and Scale-Up

Solutions for Process Development and Scale-Up

Gene Expression

Gene Expression

Detect and quantitate nucleic acids in your scale-up/scale-down batches. Identify and measure any copurifying residual host cell DNA.

Droplet Digital™ PCR Systems
ddPCR™ Supermixes for Residual DNA Quantification
Real-Time PCR Systems with High-Throughput Automation

PCR Instrument Validation Tools and Services


Protein Purification

Protein Purification

Develop and finesse protein purification strategies across process development and scale-up using our extensive range of chromatography resins and instrumentation.

NGC™ Medium-Pressure Chromatography Systems with IQ/OQ and CFR-Compliant Software
Chromatogtaphy Columns and Resins
Chromatogtaphy Resin Screening Tools

Protein Analysis

Protein Analysis

Use our comprehensive protein analysis tools to monitor protein profiles throughout scale-up and validate antibodies used to detect and identify contaminating host cell proteins (HCP).

Western Blotting Reagents and Equipment
Validated Western Blotting Antibodies
Stain-Free Gel and Western Blot Imaging Systems
GS-900™ Calibrated Densitometer and Regulatory Tools (CFR validated for cGMP)
Antibody Validation for Host Cell Protein (HCP) ELISAs



Save process development time with a wide selection of off-the-shelf antibodies. Utilize our custom antibody services for more specific antibody requirements, including for assay manufacturing purposes.

Antibodies by Application
Antibodies by Target Species
HuCAL® Custom Antibody Services

Additional Methodolgies and Research Within Drug Discovery and Development
  • Biochemical and Cellular Assays

    Biochemical and Cellular Assays
    In vitro and in vivo discovery approaches with high sample throughput and high-content analysis to characterize biological responses.

  • Biomarker Discovery

    Biomarker Discovery & Validation
    Biomarker monitoring across drug discovery, development, and clinical stages is key to defining drug effects.

  • Biologic Development

    Biologic Development
    Biologic development brings patients closer to personalized medicine to treat health problems.

  • Biosimilar Development

    Biosimilar Development
    Biosimilar development requires physicochemical and functional characterization to ensure similarity.

  • Cancer Immunotherapy Development

    Cancer Immunotherapy Development
    Learn about trends in cancer immunotherapy development, such as CAR-T, and tools for genomic, cellular, and proteomic research.

  • CRISPR Gene Editing

    CRISPR Gene Editing
    CRISPR enables researchers to edit their desired target genes efficiently and accelerate drug development.

  • Viral Vector Vaccine Development

    Viral Vector Vaccine Development
    The COVID-19 pandemic opened the door to expedited vaccine development using new technologies and therapies that have traditionally been used in other applications.