Latest Conference

Todd Andrews, global director of Applications and Business Development at CPC, discusses sterile aseptic connectors, flexibility in manufacturing, and more in an interview held at INTERPHEX 2023.

For more INTERPHEX 2023 video content, check 

Articles

Discussing Sterile Aseptic Connectors with Todd Andrews (INTERPHEX 2023)

JP Bornholdt, director of modular operations, CRB, and an INTERPHEX Keynote speaker in the 

Applied Continuous and Modular Manufacturing Innovations session

, discusses the impact that continuous manufacturing and modular innovations have on biomanufacturing.

JP Bornholdt, director of modular operations, CRB, discusses continuous and modular manufacturing.

Continuous and Modular Manufacturing Innovations: Discussion with JP Bornholdt (INTERPHEX 2023)

Ken Gilmartin, CEO, Wood, gives his insight on what's currently in demand in terms of new bio/pharma manufacturing facilities. He emphasizes that a significant amount of capital is being invested in the United States for facilities, particularly in the large molecule and cell and gene therapy sectors.

Wood CEO Ken Gilmartin gives his insight on what's currently in demand in terms of new bio/pharma manufacturing facilities.

Trends in Bio/Pharma Facilities: Ken Gilmartin Gives His Perspective (INTERPHEX 2023)

Bas Trietsch, chief technology officer, MIMETAS, and one of the INTERPHEX Keynote speakers in the 

Organ on a  Chip for Pharmaceutical Development session

, discusses the successes his company has encountered so far using organ on a chip technology in bio/pharmaceutical research.

Bas Trietsch, chief technology officer, MIMETAS, discusses the successes he's encountered so far using organ on a chip technology in bio/pharmaceutical research.

Bas Trietsch Discusses Successes so Far Using Organ on a Chip Technology for Bio/Pharmaceuticals (INTERPHEX 2023)

Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, and one of the INTERPHEX Keynote speakers in the 

, discusses the barriers in implementing organ on a chip technology as well as the need for researchers and scientists to think critically about the data generated from this technology for pharmaceutical development.

Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, discusses the barriers in implementing organ on a chip technology.

Organ on a Chip Technology: Discussion with Yaakov Nahmias (INTERPHEX 2023)

Isaac Bentwich, MD, CEO and co-founder of Quris-AI, and one of the INTERPHEX Keynote speakers in the 

, gives his thoughts on the confidence level of data generated from organ on a chip technology.

Isaac Bentwich, MD, CEO and co-founder of Quris-AI, discusses organ on a chip technology.

Organ on a Chip Data Integrity Discussion with Issac Bentwich (INTERPHEX 2023)

James Rorke, vice-president, operations, Steriline North America, discusses the advantages of automation in fill/finish, particulary for low volume, high quaility products such as cell and gene therapies, for which minimizing product loss is crucial.

James Rorke, vice-president, operations, Steriline North America, discusses the benefits of automation in fill/finish operations.

Talking Automation in Fill/Finish and Cell & Gene Therapies with James Rorke (INTERPHEX 2023)

Martin Smyth, senior vice-president of Go-To-Market Strategy at MasterControl, discusses gaps in digitalization in the pharma industry, and how crucial digitalization is for bio/pharma manufacturing processes. 

Martin Smyth, senior vice-president of Go-To-Market Strategy at MasterControl, discusses gaps in digitalization in the pharma industry. 

Gaps in Digitalization: A Discussion with Martin Smyth (INTERPHEX 2023)

Alessandro Zannini, sales director, engineering division, Stevanato Group, discusses artificial intelligence and digitalization in the pharma field and addresses challenges associated with with visual inspection, assembly, and secondary packaging processes for pharma companies.

Alessandro Zannini, sales director, engineering division, Stevanato Group, discusses artificial intelligence and digitalization in the pharma field. 

Discussing AI and Digitalization with Alessandro Zannini (INTERPHEX 2023)

After using a process analytical technology (PAT)-automated tangential flow filtration (TFF) system that is controlled by real-time concentration measurement for ultrafiltration and diafiltration (UF/DF) processes, it was found to be an innovative solution for companies looking to automate their TFF process and increase process control, according to a poster study from Derek Carroll and Teva Smith from Repligen, which was presented at INTERPHEX 2023 between April 25-27 in New York City.

Using real-time concentration management is intended to ensure consistent targeted concentration results, insensitive to the types of variation commonly seen in mass balance-only systems. Further, automated process control is demonstrated for various final concentration endpoints, which suggests a better solution for the UF/DF process with key advantages over existing methods, according to Carroll and Smith.

Carroll and Smith used the Repligen real-time process management system (RPM) automation, which is driven by an in-line variable pathlength UV/Vis device, the CTech FlowVPX system. This system’s search algorithm assigns a collection start value of 1 absorbalance and measures 5 to 10 decreasing pathlengths to generate a slope value, according to the poster.

Carroll and Smith then introduced the KrosFlo KR2i RPM System, which utilizes Open Platform Communication-United Architecture (OPC-UA) to provide seamless PAT-driven process control with two-way communication between each device within the system. The RPM system using innovative PAT and OPC-UA reduces user input, greater process control, and reliable process output.

The objective of the study was to integrate an automated TFF process based on real-time concentration, and the study included testing the efficacy of the systems automation via repeatably and post-run mixing outcomes. To achieve this, the FlowVPX variable pathlength spectrophotometer and KrosFlo KR2i TFF system conducted a total of 15 UF/DF processes. The UF/DF runs were conducted using bovine serum albumin (BSA) in replicates of three with starting concentrations 5, 7.5, and 10 mg/mL. The final target concentrations for the processes were 50, 125, and 200 mg/mL. A method was then developed to create parameters for each item to react. The endpoints for concentration 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 highlighted that 12 out of the 15 processes to be within -0/+5 specification for target post run mixing concentration. Higher flux and lower final pool volume runs were more susceptible to over concentrate, while lower flux and higher final pool volume runs were susceptible to under concentrate.

The poster authors conclude that real-time concentration 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.

Source: Carroll, D and Smith, T. Automated PAT-Driven TFF System Using In-Line Concentration Monitoring to Control the UF/DF Process. Poster. INTERPHEX 2023. New York, NY. April 26, 2023.

The results found that repeatability testing found all 15 processes to be with in specification for target final concentration.

Latest Conference Articles