Biopharmaceutical manufacturers are continuously striving to find efficiencies and make improvements across downstream processing steps to improve product quality, reduce costs, and accelerate the development of safe and effective biopharmaceuticals.

Chromatography plays a critical role in the purification of biopharmaceutical products. However, developing chromatography processes can be a challenging task because it involves balancing factors such as selectivity, yield, and productivity while maintaining the purity and quality of the final product. Strategies for process development are evolving and include design of experiments (DoE) and high throughput process development (HTPD). These strategies accelerate process development and increase process understanding, but they require multiple experiments and extensive data analysis, which can be time consuming and resource intensive.

To overcome these challenges, the biopharma industry is increasingly turning to chromatography modeling software and mechanistic modeling to optimize chromatography processes.

What is mechanistic chromatography modeling?

Mechanistic chromatography modeling is a valuable tool to speed up downstream process development and improve manufacturing outcomes. Mechanistic models create in silico, computer simulations of chromatograms. The models use mathematical equations based on fundamental principles of mass transfer, thermodynamics, and fluid mechanics to help users understand process variability and improve process understanding.

The benefits of using mechanistic modeling include:

• Reduced number of experiments
• Easily interpreted model parameter values
• Extrapolation beyond the boundaries of your experiments
• The ability to conduct risk assessments
• Development of effective design space and control strategies
• Facilitated tech transfer because the model can be scaled up
• Root cause analysis
• Improved process understanding and support of QbD

GoSilico™ Chromatography Modeling Software

GoSilico™ Chromatography Modeling Software from Cytiva is a software solution tailored for and used by many biopharma companies that performs in silico mechanistic modeling. It accelerates early- to late-stage chromatography process development, scale-up, troubleshooting, and chemistry, manufacturing, and controls (CMC).

The software uses factors such as solute properties, column characteristics, and mobile phase conditions to predict chromatographic behavior. It needs only a few calibration experiments to create a digital twin of your downstream process. A simulated chromatography run can thereby replace a physical experiment enabling you to generate thousands of in silico purification options in just a few hours (Fig 1). This method saves time, reagents, and costs by reducing the number of wet lab experiments. It also can help improve process knowledge and process robustness, facilitate tech transfer, and further support regulatory decision making.

A standard license package includes the installation on one computer and one user account, but you can add more computer licenses and user accounts as you need them. During your chosen license period, updates and technical support are free. An additional feature of GoSilico™ software is that it provides seamless lab integration by optimally linking to Cytiva ÄKTA™ systems and UNICORN™ software.

To see the capabilities of GoSilico™ Chromatography Modeling Software in action, view the video demonstration here:  See GoSilico™ Chromatography Modeling Software in action