Cost-Effectivity Due to Improved Productivity in mAb Capture
Changing anything in the antibody purification workflow requires an ironclad business case. Without this, it is impossible to motivate investing in new technologies. Here, we lay out the reasons for switching to membrane chromatography and invite you to find out more in the case studies in our newly published whitepaper.
This article is posted on our Science Snippets Blog
The process of capturing monoclonal antibodies (mAbs) using Protein A resin and capture chromatography is well established, but subject to some common challenges. Protein A chromatography has dominated the industry due to high levels of sample purity, but despite the widespread adoption, capture using Protein A resins is not without its drawbacks. While protein A ligands can provide >95% purity for monoclonal antibody purification, resins suffer from low productivity due to diffusive mass transport, which can lead to bottlenecks in the production process.
Typical Protein A resins have productivity in the range of 10 – 20 g/L/h, which is relatively low and typically requires large processing times downstream when implemented at manufacturing scale. To generate an ROI, resins also must be used for the entirety of their intended lifetime which adds constraints to the production process especially for challenging molecules in a pre-clinical phase. This is particularly problematic when a plant needs to generate its ROI in a timely manner. Extended use times often lead to increased column handling, which has additional risks such as higher likelihood of bioburden or cracking ruining a production run and requiring the disposal of expensive, underutilized Protein A resin. In addition, the current industry needs for ever increasing productivity, and the drawbacks of resins being expensive, slow, and prone to costly errors such as contamination or cracking are causing even the most conservative manufacturing plants to consider alternatives.
Fortunately, there are alternative methods that are currently being explored. These methods are focused on enhancing the productivity of the capture chromatography process while reducing costs and risks. One such method involves using rapid cycling chromatography (RCC) using membranes, which eliminates the need for columns altogether.
RCC is a process which involves separation or purification of biomolecules with relatively short cycle times of 10-15 minutes, thereby drastically increasing the productivity of the unit operation when compared to diffusion-based chromatography media. This approach enables the use of smaller, more efficient capture devices that can be fully utilized in a shorter period of time, resulting in higher productivity. It also means that the production facility can be amortized much faster and significantly reducing the financial risk to the manufacturing plant.
Here is an excerpt from our new white paper “High Productivity Drives Cost-Effectivity at Capture Chromatography for Biologics Development and Manufacturing” where we detail exactly how exactly how RCC compares to resin bed chromatography.
Table 1. How RCC compares to bed chromatography
The move to rapid cycling chromatography represents a major step forward in the bioprocessing industry's efforts to improve process economics and mitigate risk. By shortening cycle times and increasing productivity, RCC can help companies bring their products to market faster and more efficiently. As a result, RCC is quickly gaining traction as a promising alternative to traditional capture chromatography methods, and we are excited to be at the forefront of this exciting new technology.
Our experts have assembled a whitepaper exploring the cost savings and productivity gains that come from membrane RCC. In it we introduce Sartobind® Rapid A and provide details for how it can make processes faster, cheaper, and less risky. We take data from our own labs as well as published work, but we also provide 3 important case studies that show how RCC can work in the real world.
These case studies are:
- Case Study 1: Comparability of CQA & Reduced Risk with Sartobind® Rapid A
See how much of a productivity increase you could achieve by switching to membranes and operating Sartobind® Rapid A in One-Batch, One-Membrane format. - Case Study 2: Cost Reduction
Learn how membranes can save money in your process with a specific example showing a 30% COGS saving. - Case Study 3: Scalability, Flexibility, and Time Savings at Commercial Scale
See how membrane based RCC can remove some of the significant scaling headaches when moving from PD to manufacture.
Membrane based RCC processes offer significant advantages over traditional resins, including faster cycle times, higher productivity, and reduced risk of contamination. By using smaller, more efficient columns that can be run for shorter periods of time, RCC enables bioprocessing companies to achieve greater than 10X productivity, significantly reducing costs and accelerating time-to-market.
