Manufacturing, Continuous Solid Dosage Processing

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.

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

Early adopters of continuous manufacturing approaches shared their plans and some of their experiences at the 11th annual Charles Jarowski Symposium in Industrial Pharmacy.

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

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

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.

Educational sessions on the INTERPHEX show floor will include a panel discussion on implementing continuous manufacturing.

In OSD continuous manufacturing, flexible batch sizes can optimize supply, but equipment and processing challenges are still being addressed.

FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.

The RK-1 continuous mixing processor from Readco Kurimoto is suited for testing formulations in continuous processing conditions.

Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

Mechanistic process and product modeling turns data into knowledge that can be extrapolated with known confidence for design space characterization and risk assessment.

A twin-screw extruder can be used as a continuous wet granulator.

Coperion’s ZSK 18 MEGAlab extruder fulfills requirements for both wet extrusion and hot-melt extrusion pharmaceutical processes.

A twin-screw extruder can be used as a continuous wet granulator or as a continuous mixer for a wet gelatin mass.

The new industry-led Medicines Manufacturing Innovation Center (MMIC) will offer a unique service to develop and implement novel manufacturing techniques.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

The UK’s University of Sheffield opened a new chemical engineering teaching plant for continuous oral solid-dosage pharmaceuticals using GEA’s multipurpose platform.

GEA and Perceptive Engineering will collaborate to promote and deploy multivariate monitoring and advanced process control (APC) solutions for batch and continuous pharmaceutical process units.

As more continuous processes move toward commercialization, users and equipment vendors are working to speed changeovers and address other needs.

L.B. Bohle’s QbCon 1 laboratory-scale, continuous twin-screw granulator and dryer offers fully continuous drying for R&D in continuous solid-dosage manufacturing.

The pharmaceutical industry is adopting Industry 4.0 and emerging technologies to improve product quality and manufacturing efficiency.

Process analytical technology and advanced process control strategies can be applied to either batch or continuous manufacturing of solid-dosage drugs.

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

A systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.

Fette Compacting and Glatt have joined forces to develop integrated solutions for the continuous manufacturing of oral solid-dosage drug forms.

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.