Process Control, Automation, and PAT

Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

Real-time monitoring of product- and process-related impurities remains a challenge.

Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.

The learning curve for process analytical technology has slowed widespread adoption.

Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.

GE Healthcare launches Chronicle GMP-compliant automation software for cell therapy manufacturing.

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.

Technical advances in process understanding and control must be accompanied by a change in mindset.

The GE Healthcare and Rockwell Automation collaboration will help meet the needs of the biopharma 4.0 era.

As automation in biomanufacturing becomes more important, so does the need to integrate process data.

The companies partnered to build a 500-L single-use pilot-scale plant for biologics production.

Applied throughout a product’s lifecycle and across a company’s portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.

Non-destructive surface area measurement can improve stability testing.

New software tools by Tecan, a provider of automated laboratory instruments and solutions, complement each other to enhance process monitoring of its liquid-handling platforms.

Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.

FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems.

ABB’s modeling software, Shop Floor Integration V2.0, allows engineers to validate the connection of existing pharmaceutical manufacturing equipment with Werum’s PAS-X manufacturing execution system in a simulation prior to running it live.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.