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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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

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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