Optimizing Cell Line Development With Automated mAb Sample Preparation
Cell line developers usually handle up to 50 monoclonal antibody (mAb) samples simultaneously in multi-parallel bioreactors to maximize the chances of finding a high-performing clone. Streamlined sample preparation solutions are necessary to avoid overloading the purification team with samples, leading to cell line development bottlenecks. Learn what features you should look for in your equipment.
This article is posted on our Science Snippets Blog
Technological advances in early cell line development (CLD) workflows, such as Sartorius’ high throughput bioreactor platform Ambr® 15, have transformed the way early screening for process optimization and clone selection is performed. Equipped with advanced sensing technologies, the Ambr® 15 allows users to simulate a bioprocessing environment representative of larger-scale bioreactors used in pilot and manufacturing plants. Ambr® 15’s automation reduces the time required to process clones, enabling higher throughput in CLD and ultimately reducing the drug-to-market timelines.
However, without the appropriate sample preparation tools, the bottleneck is pushed to analytics and limits the cell culture feedback loops (Figure 1). Drug developers need streamlined solutions for fast sample preparation to harness the full benefit of upstream process automation.
Figure 1. The fast sample preparation enabled by the Streamlink® CC 15 facilitates new development models.
How to Streamline Sample Preparation in CLD Workflows
What features should you look for when optimizing your sample preparation process?
Automation
Manual sample processing is time- and resource-intensive. An automated and walkaway system would free up valuable operator time. However, this must be accompanied by sophisticated error recovery processes to avoid process interruptions.
Consistency
Minimizing sample-to-sample variation is a priority for all robust bioprocesses. Modern solutions possess tight control systems to drive a high level of consistency. Moreover, automation will limit human error and also increase process repeatability.
Speed
Time-to-market is a significant business driver. In high-throughput operations, sample preparation can be particularly time- and resource-consuming. Systems that accelerate existing processes are favorable.
Small Footprint
Minimizing footprint can help minimize overhead costs, increase flexibility, and improve sustainability. A compact, multi-purpose system limits the need for multiple pieces of equipment, creating a smaller footprint and simplifying downstream operations.
Easy-to-Use
Biomanufacturers are under significant time pressure. When implementing new tools, simple and intuitive systems that do not require extensive user training and specialization are preferred.
Flexibility
Modern biopharmaceutical facilities should be flexible to adapt to the constantly changing landscape. A sample preparation system that is adaptable to different process setups (such as different cell lines, cell densities, and product concentrations) is ideal for avoiding costly and time-consuming equipment changeover.
Introducing the StreamLink® CC 15
The StreamLink® CC 15 is the first automated high throughput system that streamlines the preparation of cell culture samples produced in Ambr® bioreactors (Figure 2). The specialized Ambr® 15 vessel holder allows the “plug-and-go” transfer of vessels directly onto the StreamLink® CC 15 to minimize risk and maximize efficiency. The combination of Ambr® 15 and StreamLink® CC 15 promises to revolutionize the bioprocessing space and the speed at which drug candidates can be taken to market.
Figure 2. Sample preparation and critical quality attribute (CQA) analysis is resource-intensive. Biopharmaceutical manufacturers need fast and effective solutions to make data-driven decisions and reduce time between culture runs.
The combined process carries out clarification and purification steps in a novel one-step workflow (Figure 2). The system can clarify and purify 24 mAb-expressing cell culture samples in as little as 2 hours, accelerating testing while maintaining quality through automated, optimized protocols.
How Does the StreamLink® CC 15 Work?
The StreamLink® CC 15 has three configurable processes:
- Clarification using the Sartoclear® Disc, a single-use multi-layer clarification filter
- Purification using the multi-use Sartobind® Rapid A nano, Protein A membrane adsorber
- Combined processing (clarification and purification)
The system allows the user to run a single integrated clarification and purification process using an automated robotic pipettor to transfer 24 or 48 bioreactor samples (from Ambr® 15 or any other suspension cell culture) for processing in a fully walkaway process.
The intuitive software comes pre-configured with a ready-to-go process while also allowing the user to define several automated control features for further optimization if required, including differential pressure control of clarification, UV peak cutting of the eluate, and output sample neutralization.
Figure 3. Sample preparation for a critical quality attribute (CQA) analysis workflow in a standard process compared to the StreamLink® CC 15.
Final Thoughts
To maximize the chances of finding a high-performing clone, cell line developers usually handle 20-50 samples simultaneously in multi-parallel bioreactors, such as the Ambr®15. StreamLink® CC 15 provides an automated, streamlined workflow downstream of Ambr® bioreactors, accelerating sample preparation for CQA analysis and speeding up clone selection. This can be achieved by freeing up resources to analyze more samples, analyzing samples directly from the Ambr®15, and avoiding hold times (Figure 3).
The system is designed to seamlessly work alongside the existing products within the Sartorius CLD portfolio, creating simplified, integrated workflows that speed up drug discovery and time to market.
Download the application note to learn about the utility of the system in a mAb production process.
