Process and Automation

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.

Equipment and systems for aseptic transfer and manufacture meet cGMP and Annex 1 requirements for pharmaceutical fill and finish.

At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.

A collaboration between Insilico Biotechnology and IFAT aims to develop a manufacturing, planning, and control system for the production of monoclonal antibodies.

Marchesini Group’s Compact 12 electronic counter with HarleNIR vision system measures product and active ingredient when filling and capping bottles for tablets and capsules.

TrendMiner 2019.R3 displays a customized, actionable dashboard with a real-time view of the production process.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

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

Lonza plans to implement MES software to accelerate paperless, 24/7 production of drug capsules.

Process Automation Solutions becomes the latest partner to join the TrendMiner ecosystem.

Rockwell Automation’s updated FactoryTalk AssetCentre software supports several new types of production assets.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

A presentation at the Leistritz Pharmaceutical-Nutraceutical Extrusion Seminar explained how simulation tools benefit the development process.

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

The Allen-Bradley ControlLogix 5580 controller from Rockwell Automation is compliant with the IEC 62443-4-2 security standard.

The FactoryTalk Analytics LogixAI module from Rockwell Automation detects production anomalies.

A data exchange program between GE Healthcare and Amgen aims to improve biologics manufacturing through analysis of how raw materials affect the process.

The UK’s Centre for Process Innovation is collaborating with partners GSK and AstraZeneca to establish a continuous wet granulation manufacturing facility for small-scale development of oral solid-dosage pharmaceuticals.

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

Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.