Sterile media hold scale-up using MOBIUS® single-use technology

The benefits of single-use systems (SUS) in biopharmaceutical manufacturing are well understood, and their use is widespread in the manufacture of mAb, rProteins, and related therapies. New frontiers in medicine such as cell and gene therapy present an opportunity for SUS to enable speed to the clinic, however some unique hurdles must be overcome. This poster outlines the collaborative development of a single-use process to address the challenge of supplying sterile media to a bioreactor for inoculation and growth of human tissue cells. To alleviate time constraints, cleaning concerns, and contamination risks, the biopharmaceutical manufacturer chose to employ single-use technology when conducting a 5-fold scale up from a glass bottle process. A significant challenge with this human tissue cell culture process is the 60-day sterile media hold at the cell culture temperature of 36oC, during which time the bioreactor is intermittently perfused with fresh media. The Mobius® Mix50 single-use mixer (SUM) solves this challenge by first beginning with a sterile, gamma-irradiated mixer bag to eliminate concerns over validation of CIP and SIP cycles. Next, a low-pressure overlay is maintained with a carefully-sized hydrophobic vent filter, to prevent contaminants from entering the sealed mixer container. Process variables requiring assessment for this application include the air overlay pressure and flow rate, the liquid (media) flow rate during filling and draining of the SUM, sizing of the vent filter area, the liquid volume in the SUM, and the sterile condensate collection rate. A series of experiments provided a repeatable and scalable single-use solution for implementation into the manufacturing process. This novel application demonstrates the flexibility of single-use in the rapidly expanding clinical market of products derived from human cells with the unique challenges they present

Graphical representation of data for a multiprocessor platform emulating spiking neural networks

Research in the eld of simulating large-scale spiking neural networks (SNN) has been carried out within the frame of Perplexus a European-funded re- search project based on a university consortium. In this project, a semi- custom electronic device called Ubichip has been designed. The mode of interest of this chip to emulate SNNs is based on a SIMD (Single-Instruction Multiple-Data) multiprocessor machine. The software for generating the as- sembly containing simulation of Iglesias-Villa spiking neural network model was also developed within that project and it is currently being successfully used for running neural network emulation on Ubichip. The tools developed so far are useful for debugging by simulation, but in order to evaluate the behavior of SNN being emulated, two needs arose: real- time monitoring of the network evolution and a higher-level, understandable visualization solution. First, the existing software that was developed in the Perplexus project has been analyzed. After examining all available solutions, including writing a standalone dedicated program, it was nally decided to develop the so-called Ubiplot plug-in. The reason was to take advantage of the existing Ubimanager environment. The development started by verifying the communication with the Ubichip, so simple waveforms for data in a given address in the Ubichip's RAM were implemented. Then the plug-in was extended with histogram and raster plots that are accessing multiple locations of the memory in each execution step. This led to the creation of the variable map that de nes the program's variables and their precise placement in the RAM. At the end simple logging facility and possibility to save and restore the layout of the plots were added. This thesis describes the Ubiplot and the development e ort put in its creation

Graphical representation of data for a multiprocessor platform emulating spiking neural networks

Research in the eld of simulating large-scale spiking neural networks (SNN) has been carried out within the frame of Perplexus a European-funded re- search project based on a university consortium. In this project, a semi- custom electronic device called Ubichip has been designed. The mode of interest of this chip to emulate SNNs is based on a SIMD (Single-Instruction Multiple-Data) multiprocessor machine. The software for generating the as- sembly containing simulation of Iglesias-Villa spiking neural network model was also developed within that project and it is currently being successfully used for running neural network emulation on Ubichip. The tools developed so far are useful for debugging by simulation, but in order to evaluate the behavior of SNN being emulated, two needs arose: real- time monitoring of the network evolution and a higher-level, understandable visualization solution. First, the existing software that was developed in the Perplexus project has been analyzed. After examining all available solutions, including writing a standalone dedicated program, it was nally decided to develop the so-called Ubiplot plug-in. The reason was to take advantage of the existing Ubimanager environment. The development started by verifying the communication with the Ubichip, so simple waveforms for data in a given address in the Ubichip's RAM were implemented. Then the plug-in was extended with histogram and raster plots that are accessing multiple locations of the memory in each execution step. This led to the creation of the variable map that de nes the program's variables and their precise placement in the RAM. At the end simple logging facility and possibility to save and restore the layout of the plots were added. This thesis describes the Ubiplot and the development e ort put in its creation

Graphical representation of data for a multiprocessor platform emulating spiking neural networks

Research in the eld of simulating large-scale spiking neural networks (SNN) has been carried out within the frame of Perplexus a European-funded re- search project based on a university consortium. In this project, a semi- custom electronic device called Ubichip has been designed. The mode of interest of this chip to emulate SNNs is based on a SIMD (Single-Instruction Multiple-Data) multiprocessor machine. The software for generating the as- sembly containing simulation of Iglesias-Villa spiking neural network model was also developed within that project and it is currently being successfully used for running neural network emulation on Ubichip. The tools developed so far are useful for debugging by simulation, but in order to evaluate the behavior of SNN being emulated, two needs arose: real- time monitoring of the network evolution and a higher-level, understandable visualization solution. First, the existing software that was developed in the Perplexus project has been analyzed. After examining all available solutions, including writing a standalone dedicated program, it was nally decided to develop the so-called Ubiplot plug-in. The reason was to take advantage of the existing Ubimanager environment. The development started by verifying the communication with the Ubichip, so simple waveforms for data in a given address in the Ubichip's RAM were implemented. Then the plug-in was extended with histogram and raster plots that are accessing multiple locations of the memory in each execution step. This led to the creation of the variable map that de nes the program's variables and their precise placement in the RAM. At the end simple logging facility and possibility to save and restore the layout of the plots were added. This thesis describes the Ubiplot and the development e ort put in its creation