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Volume 32, Issue 7
Recently released equipment and products include microbioreactor systems, cell therapy automation software, and IIoT-enabled flow sensors.
New and updated technologies have been released over the past few months for a range of bioprocessing tasks to spark innovation and support efficiency. The following are a sampling of such products.
A new generation of the ambr 15 cell culture automated microbioreactor system from Sartorius Stedim Biotech (SSB) offers increased flexibility and expanded capability for clone selection, media and feed optimization, and early process development work (1).
The Generation 2 system replicates laboratory-scale bioreactor performance at the 10–15 mL microscale and controls up to 48 single-use bioreactor cultures in parallel. The updated design incorporates new features to improve process flexibility, expand the system’s functionality, and allow more applications to be investigated.
New features include a one-year license of SSB’s clone selection software, which provides simplified, streamlined multivariate data analysis for faster, more consistent cell-line screening and ranking, according to the company. Using the Âsystem’s new functionality, election of clones, media, and feeds can be performed under perfusion mimic conditions to bleed large volumes of culture and quickly remove spent media from the microbioreactors. The company states that a new flexible workstation layout and an expanded tip bin capacity provide greater operator walk-away time.
New culture passage steps and rapid vessel drain functionality allow for the adaptation of cell lines to different media for media screening studies to be performed in the microbioreactors. New media mixing steps automate the creation of media blends, eliminating the need to pre-mix. Clone stability studies can also be set up with serial passages performed and fully automated in the microbioreactors. Rapid vessel drain functionality for automated cell passaging and media exchanges in the microbioreactors supports cell and gene therapy applications. New culture station design provides lower stirrer speed control suitable for more sensitive cell lines.
The system also provides a robust screening platform for development of cell and gene therapy processes, including HEK293 for viral vector production, T-cells, induced Âpluripotent stem cells, and other immune-derived cell lines.
The Chronicle web application, the next generation of GE Healthcare’s my.Cryochain software, now supports the complete cell therapy workflow (2). Chronicle automation software is a GMP-compliant, fit-for-purpose digital solution for the optimization of complex cell therapy process development and manufacturing.
Chronicle automation is suited to increase efficiency while meeting regulatory compliance using real-time supply chain tracking, hardware performance monitoring, SMS or email alarms, and comprehensive electronic batch records. Software capabilities include a unified digital space that monitors all facility manufacturing operations and supply chain logistics with real-time data acquisition and notifications. According to the company, electronic batch records increase productivity, reinforce GMP compliance, and improve the security of patients’ samples through increased traceability.
Built by cell therapy platform solution engineers, the software supports electronic standard operating procedures, which are suitable for specific processes to manage deviations, promote adherence to protocol, and provide guidance to ensure sensitive patient cells are handled appropriately. Additionally, the software integrates with the full range of GE instruments as well as many third-party instruments and has been independently audited against GAMP5, 21 Code of Federal Regulations Part 11, and EU Annex 11.
Watson-Marlow Fluid Technology Group (WMFTG) expanded its BioPure gasket range for high purity fluid management (3). The high-purity gaskets cover a range of applications and support leak resistant connectivity within pharmaceutical and biotechnology production processes, reducing validation risks in contamination-free applications.
According to WMFTG, the gaskets use new materials-polytetrafluoroethylene and a synthetic rubber and fluoropolymer elastomer (Viton, Chemours)-to provide a high level of chemical and steam resistance. Each of the high-purity gaskets have been engineered to deliver improved sealing performances under clamping compression. The BioPure range offers lot traceability on every component, silicone products manufactured and packed in an ISO 14644-1 Class 7 cleanroom, compliancy with FDA regulations CFR 21 177.2600, dedicated validation and qualification data to help achieve cGMP requirements, and USP Class VI compliance and animal-derived component free.
The Aventics AF2 flow sensor from Emerson continuously monitors air consumption, which allows for rapid leakage intervention in applications such as packaging (4). The sensor continuously monitors air consumption in pneumatic systems, enabling compliance with the energy management standard DIN ISO 50001. The device is one of various Industrial Internet of Things (IIoT) components offered by the company for networked plants in factory automation.
“The Aventics AF2 series flow sensor is ideally suited to those companies aiming to control and optimize their energy usage,” said Andreas Kliewe, expert for energy management with Emerson’s machine automation business, in an April 2, 2019 press release. “The device records the flow rate and compressed air consumption in a system, sending a signal to the controller when pre-set levels are exceeded. This helps avoid excessive energy loss and enables rapid intervention in the event of an issue.”
The company states that the device’s modular construction makes it suitable for installation where space is limited. The sensor is delivered precalibrated with its filter, which can be configured in any maintenance unit. An organic light-emitting diode display on the Âsensor provides local indication of all relevant operating and diagnostic data. The sensor is available as a normally open and normally closed version. Analog outputs can be switched with a signal from 4 to 20 mA. According to the company, these signals can be interpreted directly by many controllers.
The sensor’s IO-Link capability and the Ethernet interface enable users to communicate with existing controllers. Communications protocols integrated into the device include Open Platform Communications Unified Architecture and Message Queuing Telemetry Transport. A web-based dashboard shows real-time data for the users.
1. Sartorius Stedim Biotech, “Sartorius Stedim Biotech Launches New ambr 15 Cell Culture Microbioreactor System,” Press Release, May 2, 2019.
2. GE Healthcare, “GE Healthcare Announces Commercial Launch of Chronicle Automation Software for Cell Therapy,” Press Release, May 15, 2019.
3. Watson-Marlow Fluid Technology Group, “Watson-Marlow Fluid Technology Group Expands BioPure Gasket Range,” Press Release, May 2, 2019.
4. Emerson, “IIoT-Enabled Flow Sensor Monitors Air Loss in Pneumatic Systems to Optimize Energy Usage,” Press Release, April 2, 2019.
Vol. 32, No. 7
When referring to this article, please cite it as A. Lowry, “Up-to-Date Systems Streamline Operations," BioPharm International 32 (7) 2019.