Phil Vanek, CTO at that company, was commenting as Gamma Biosciences made a strategic investment in Nirrin Technologies, a provider of sensors and analytics for real-time, in-process monitoring and analysis in upstream and downstream bioprocessing applications.
Asked about the percentage of biomanufacturers to date adopting process analytical technologies (PAT) and advanced controls in biopharma, he told BioPharma-Reporter:
“There is a large unmet need for accurate, real-time, in-line analytics that are both simple to implement and cost effective.
“But because process analytics include a variety of testing modalities spanning the entire range of unit operations in bioproduction, including elements of upstream and downstream operations in cell and gene therapy, biologics, vaccines, and mRNA, as well as in-line, on-line and at-line testing, the PAT percentage is nearing 100%.”
Jonathan Hartmann, CEO, Nirrin Technologies, maintains that advanced control is lagging for a variety of reasons including the control architecture within the diversity of equipment being deployed in manufacturing.
“However, with new technologies and the market demand for integrated control in operations, the control aspects, or full automation, will quickly catch up.
“Our technology holds great promise to enable the future of bio-manufacturing with fast, accurate, inline measurements of critical analytes such as glucose, lactate, and proteins.”
In terms of obstacles that remain to greater use of advanced monitoring and control in biopharma, Hartmann said many of the currently available technologies have performance and reliability limitations and can be extremely complicated and/or expensive.
“We aim to solve those challenges, as well as to expand the breadth of measurements that are possible compared to existing sensing technologies (optical, chemical, or physical). It is also important to consider the physical time needed to capture and analyze data, and the integration of the collected data into a real-time control instruction set to allow for process automation.”
There is an issue with sensor technologies on the market today, however, claims Vanek. They are too are costly, slow, and/or complex, and “often measure surrogate events in the process which are then indirectly correlated to the desired metric.”
The partnership with Nirrin is looking to get around such hurdles through the application of measurement and control strategies that deliver total and viable cell density, glucose, protein concentration, and aggregation data, added Vanek.
“This tunable, fast, and reliable sensing technology platform will allow direct measurement of many of the analytes or bioprocess phenomena necessary to provide deep insights into bioprocess manufacturing conditions, and real-time on-line analytics and control,” he said.
In terms of biopharma companies that have adopted Nirrin’s tech to date, Hartmann said the team has worked closely with several of the top 20 pharma and biotech manufacturers during the early feasibility and development process. “These alignments have created a lot of excitement about the ability of Nirrin Technology to measure and monitor glucose, protein and VCD/TCD in real time.”
Vanek explained that the idea now is to continue to align with those partners, and others, to develop the initial commercial designs as appropriate. “Of course, this work is still being handled under confidential agreements, but as the technology scales, we will continue to keep the market informed on our progress.”