Process Control, Automation, and PAT

Models of biopharmaceutical processes can be used for speeding development and improving process control.

Eli Lilly and Company and industry partners, including Ziath, are focused on speeding up the drug discovery process with a fully automated lab.

Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

Horiba has joined a consortium aimed at accelerating the development of process analytical technologies for cell and gene therapy manufacturing

Optima has teamed up with the Robert-Bosch-Krankenhaus and Heidelberg University to develop a unit for decentralized, automated production of CAR-T cell therapies.

The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.

The Module Type Package standard is now supported in Emerson’s DCS and PLCs.

Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern.

Cellares has raised $82 million to accelerate the development of its Cell Shuttle, a factory-in-a-box that allows for the automation of the process of creating highly individualized cell therapies.

The need for real-time monitoring and control has spurred the development of new analytical tools.

The acquisition strategically expands SPT Labtech’s offering in sample management for life sciences.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.

Creativity and collaboration are required to overcome complex method development challenges.

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

The collaboration addresses the need for risk mitigation plans in cell therapies.

Sanofi’s Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, MA was named the Overall Award winner at the ISPE virtual annual meeting.

PAT advances are enabling improved process understanding, process control, and error prevention.

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Edge-AI technology will enable Industry 4.0 automation in pharmaceutical manufacturing.

Honeywell Forge Cybersecurity Suite’s improved industrial-grade remote access and added protection and risk monitoring aids remote operations.

Automated sampling systems and integration of PAT are overcoming some of the roadblocks to increased automation of biopharmaceutical manufacturing processes.

Ori Biotech is partnering with manufacturers and materials suppliers to develop an automated system for cell and gene therapy manufacturing.

MilliporeSigma’s Bio4C Software Suite combines process control, analytics, and plant-level automation.

Enhancements to Augury’s AI-based machine health platform include new capabilities and collaboration tools for personnel working remotely.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Sartorius and the German Research Center for Artificial Intelligence have established a research laboratory for AI in the biopharmaceutical industry.

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.