Solutions for Biosimilar Purification Process Development
We have solutions for efficient and cost-effective methods that enable researchers to demonstrate high similarity to the approved reference originator biologic.
Biosimilar Purification Process Development
Producing a drug product at a lower cost than that of the originator is a huge challenge for the biosimilar developer. To identify the best purification strategy and migrate it from lab to process scale requires a reliable stream of workflow components from instruments to resins and columns. Costs must be controlled by designing a purification strategy with the least number of steps while retaining the purity, efficacy, and structure of the biosimilar.
The NGC Chromatography System along with Bio-Rad chromatography resins enable fast and easy screening of methods and components when designing a purification strategy for biosimilars. The modular NGC System allows addition of new capabilities as you move from discovery to scale up. Software tools for scouting and multidimensional (Multi-D) chromatography automate both discovery and scale-up processes and improve reproducibility.
Bio-Rad chromatography resins can be utilized in a variety of applications, including size exclusion, ion exchange, HIC, mixed mode, and affinity chromatography. Resins are available in multiple formats, including plates, columns, and in bulk and are designed to facilitate small- to commercial-scale purifications.
Companion Products for Biosimilar Purification Process Development
- Quickly optimize purification methods using configurable scouting and automated Multi-D features
- Easy method creation to screen multiple resin types in order to identify optimal resin chemistry for the removal of product impurities
- Choose from a range of scalable, economical resins designed for process purifications
- Increase yield and decrease process time by utilizing higher binding capacity
- Flexibility to address multiple imaging needs such as multiplex fluorescence or chemiluminescence detection in addition to DNA or protein gel imaging
- Assess purity using the gold standard densitometer with automated calibration
- Security edition software module for 21 CFR 11 compliance and an Installation and Operations Qualification (IQ/OQ) Kit, allowing for easy transition from discovery to a regulated environment
- Visualize protein purity in under 30 minutes without a staining protocol
- Multiple protein gel formulations and sizes for SDS-PAGE and native PAGE applications