Process Control, Automation, and PAT

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

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

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

Automation and tools for remote monitoring are finding increased use as pharmaceutical manufacturing adapts to pandemic restrictions.

Even though many companies are at early stages of digital automation, more are evaluating BioPharma 4.0 tools and leveraging built-in automation to speed scale-up and boost efficiency.

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

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

Advanced analytics streamlines continuous manufacturing by providing improved insights to data.

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

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

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

Analyzing process and equipment data provides insights that can improve quality and productivity of pharmaceutical manufacturing.

Advanced analytics and modeling can be used to predict downstream failures, allowing for corrective action before batches are lost.

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

Energy and water waste can be improved with new technologies, and sustainability can be considered in the design of new facilities.

CDMOs must consider challenges associated with the complexity of contract pharmaceutical manufacturing when approaching digitalization projects.

Data collected through the Industrial Internet of Things enable predictive maintenance.

Advanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.

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

Predictive and prescriptive maintenance improve pharmaceutical manufacturing equipment effectiveness.

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.

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.

The pressure to improve operational technology performance combined with the rapid pace of technology change is driving adoption of new automation models in pharmaceutical manufacturing.

Systems-based pharmaceutics case studies, challenges, and new uses were discussed at PSE’s Advanced Process Modeling Forum.

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

Automated, electronic systems for raw materials tracking improve efficiency and prevent mistakes in biopharma manufacturing.

PSE, a supplier of advanced process modeling software and services, plans to become part of Siemens Digital Industries.

The Industry 4. 0 tools of augmented and virtual reality aid pharmaceutical fill/finish equipment design, training, and troubleshooting.

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.