Pharmaceutical Technology - May 2023

Pharmaceutical Technology - May 2023

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PharmTech.com Trends in Manufacturing eBook May 2023 Pharmaceutical Technology ® 35 INTERPHEX RouNduP mg/mL. A method was then developed to create pa- rameters for each item to react. The endpoints for con- centration stages of the process were being controlled through the FlowVPX concentration measurements, according to the poster. The results found that repeatability testing found all 15 processes to be with in specification for target final concentration. Further, the success rate for all process at varied start values and final concentration for KR2i RPM system emphasizes the sensitivity and reliability of PAT-based automation. The study high- lighted that 12 out of the 15 processes to be within -0/+5 specification for target post run mixing con- centration. Higher f lux and lower final pool volume runs were more susceptible to over concentrate, while lower f lux and higher final pool volume runs were susceptible to under concentrate. The poster authors conclude that real-time concen- tration measurement provided by the FlowVPX System ensures reliable concentration readings, mitigating the types of variation found in traditional mass balance setups. They mention that future studies for the RPM system will be regarding post mixing optimization and novel modality testing. Continuous manufacturing Pharmaceutical Technology interviewed JP Bornholdt, director of modular operations, CRB, at INTERPHEX 2023 about continuous and modular manufacturing. Bornholdt discussed the impact that continuous man- ufacturing and modular innovations have on bioman- ufacturing, predictions for the future, and more. PharmTech: What are the benefits of continuous and modular manufacturing, and how does it impact the bio/pharma industry? More on Organ on a Chip Bas Trietsch, chief technology officer, MIMETAS, discusses the successes he's encountered so far using organ on a chip technology in bio/pharmaceutical research. Isaac Bentwich, MD, CEO and co-founder of Quris-AI, gives his thoughts on the confidence level of data generated from organ on a chip technology. For more on this video, check out the site! For more on this video, check out the site! Yaakov Nahmias Highlights Benefits that Organ on a Chip Technology Brings to Pharma In an interview with Pharmaceutical Technology® at INTERPHEX 2023, Yaakov Nahmias, founder and chief scientific officer or Tissue Dynamics, an emerging organoid company, highlighted certain benefits that organ on a chip technology brings to the table for bio/pharmaceutical development. In particular, the technology can make possible things today that were not possible in the bio/ pharmaceutical industry before. For a long time, Nahmias explained, the industry held a vision that organ on a chip technology will eventually replace animal studies. But the real potential of this technology goes far beyond that, he asserted. "The potential of the field is doing experiments that were never possible before this. Essentially, dynamically tracking your molecule and seeing exactly how it works. What is the mechanism, not whether or not [the molecule] works," he stated. In essence, organ on a chip technology can take the industry farther afield with molecule characterization and profile data than simple "yes/no" answers. The industry can, therefore, explore more critical—and complex—questions during drug R&D and preclinical testing than whether a newfound molecule works/doesn't work as a therapeutic drug. "These are questions that we are not trained to ask in pharma. We are trained to ask, 'does it work?' or 'does it not work?'; 'at what concentration does [the molecule] work?'; and then maybe 'what is its main target?'," Nahmias emphasizes. "But now, we can actually ask much more complex questions: 'how do things work?'; 'how does a disease change and cause hepatology?'" Organ on a chip technology can facilitate the evolution of R&D studies leading to a more comprehensive, and potentially more accurate, understanding of both underlying disease mechanisms and mechanisms of action for specific therapeutic molecules. As Nahmias predicts, this is a technology that will control and lead the next decade of bio/pharmaceutical drug development. — Feliza Mirasol For more on this interview, check out the site!

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