IDEX Health & Science
Pressure to contain costs and tighten timelines of new drug development is driving the biopharmaceutical industry to move quickly towards fully automated and continuous bioprocessing.
The implementation of such an idealized manufacturing platform, frequently referred to as Bioprocessing 4.0, will rely on smart technology integrate all process analytical technologies (PAT) and unit operations in the production process. In the context of antibody drug production this includes automated analysis of all critical process parameters (CPPs) to enable real-time decision and eliminate time spent on offline analysis.
Today, most CPPs can be monitored online but antibody or product titer, one of the most important CPPs, is typically analyzed offline retroactively. Obtaining antibody titer in real time helps eliminate immediate bottlenecks in batch production and paves the way for Bioprocessing 4.0 implementation in the future.
The movement toward Bioprocessing 4.0 has been discussed in the industry for years, but in this era of social distancing and hypervigilant risk management, existing pressures are even stronger. The current pandemic and resulting economic turmoil are raising the stakes for process innovation across the biopharma industry, even for companies making drugs unrelated to coronavirus.
Production SOPs and staffing have changed radically on short notice due to social distancing requirements. Even when valuable production staff are available, complicated scheduling challenges dictate that they may no longer able to work in close enough proximity to manage legacy workflows.
Automating as many processes as possible and bringing as many CPPs online as possible will enable improved productivity with fewer manual interventions. This can help maintain development and production metrics and while complying with more rigid employee safety standards.
Several attempts have been made to bring real-time titer closer to the manufacturing suite using various core analytical technologies. Typically, these have been existing instruments with modified specifications and enhanced integration capabilities. However, complex instruments originally designed to be operated by scientists have generally not seen success in the manufacturing suite.
This is because these existing platforms were not specifically designed to fit in a bioprocessing suite to be run by operators. A titer solution which helps the industry move toward continuous antibody production must offer excellent performance, a form factor which allows it to be installed inside a manufacturing suite, and a simple UI which can be run by anyone.
There is one key point in batch production of antibodies where a bottleneck is typically created: slow turnaround of offline titer analysis.
A new purpose-built system for monitoring antibody titer has the potential to bring one of the most challenging critical process parameters in antibody production online and into the manufacturing suite. A new product from IDEX Health & Science has adapted a trusted chromatographic method into a streamlined instrument to make antibody titer available on demand.
The purpose of the recently launched Tridex Protein Analyzer is to offer an immediate solution to production titer bottlenecks and enable online titer measurement, remote monitoring and the potential for titer-based process control. Having the ability to measure titer quickly and easily at the tank is a first step to facilitating continuous bioprocessing.
There is one key point in batch production of antibodies where a bottleneck is typically created: slow turnaround of offline titer analysis. Once the cell culture is complete, a reliable titer measurement is required to transition to downstream processing. Results of offline titer analysis can take 24 hours or longer to reach the manufacturing team relying the data to make decisions about downstream processing. Eliminating uncertainty and costly delays during the upstream to downstream transition can minimize product hold times, adding up to days or weeks of suite time saved in a year. However, the cost, complexity, and footprint of most titer solutions on the market preclude them from easy placement in the manufacturing suite to provide real time titer.
The compact form factor of the Tridex Protein Analyzer allows it to be placed inside the manufacturing suite and its simple push-button operation makes it convenient for busy technicians to run samples when a decision is required. Because the instrument is always on and ready to accept a sample, the true turnaround time for a titer measurement is just a few minutes.
In addition to providing high value manual titer measurements at-line, the Tridex unit is compatible with automated online sampling systems. This opens the possibility of monitoring titer automatically with cycle times measured in minutes, rather than hours or days. Automated titer checks can take the uncertainty out of a process where titer is often measured retroactively from daily samples stored in a freezer. This can minimize sample handling and storage risk as well. Real-time titer monitoring allows a process to be designed around direct measurement of product rather than indirect measurements of cell density and viability. Furthermore, incorporating online titer measurement into network can enable remote monitoring giving an additional piece of mind to teams working from home.
Fully integrating titer measurement into an existing production platform opens new possibilities for process innovation. Using existing technology, closed loop control of a bioreactor run based on titer is extremely challenging in development and nearly impossible in manufacturing. Having titer data available in real time provides a new level of process insight and allows that data to be used to control instead of just monitor a process.
There are many automated perfusion platforms on the market which would benefit from incorporating automated titer measurement. Monitoring cell density is central to a perfusion but more insight into the specific productivity of each cell could help optimize the process. In this way, real-time titer solutions like Tridex could improve overall efficiency and raise the expectations for product titers throughout the bioprocessing industry.
The Tridex Protein Analyzer is a standalone antibody titer device which uses a propriety trap and elute chromatographic assay and UV detection to provide accurate IgG titer measurements in under five minutes. Performance of the system aligns closely with HPLC Protein A over a dynamic range of 0.1 to 10 g/L.
The easy to operate touch screen user interface and completely plug and play consumables allow anyone to take a titer measurement with no formal training.
Tridex was designed and engineered by IDEX Health & Science specifically for bioprocessing. It is compatible with commercially available automated sampling systems for complete integration into a bioprocessing suite.
The Tridex Protein Analyzer is a completely unique solution which addresses a critical need in the biopharma industry. To learn more about Tridex, please visit www.idex-hs.com/bioprocessing.
Visit: www.idex-hs.com/bioprocessing Email: IHSBioProcess@Idexcorp.com
A titer solution which helps the industry move toward continuous antibody production must offer excellent performance, a form factor which allows it to be installed inside a manufacturing suite, and a simple UI which can be run by anyone.
