Manufacturing, Drug Products

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

Barrier materials, scavengers, and good seal integrity maximize shelf-life of oral solid-dosage drug packaging.

Engineering controls and safe practices for containment protect both operator and product in tablet and capsule production.

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

3D printing is being explored as a manufacturing method for on-demand, personalized medicine.

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

At CPhI World-Wide 2018, Bosch will display its Xelum R&D for laboratory-scale continuous OSD production and its new data-mining service for equipment and process troubleshooting.

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.

Ross, Charles & Son’s new mixing and discharging turnkey system is capable of extruding finished product into strands.

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

The company installed a ZSE-3D twin screw extrusion system at its Somerville, NJ process laboratory.

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

A process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.

Jean-Yves Balfin, product manager at Korsch AG, speaks to Pharmaceutical Technology about the ins and outs of multilayer tableting.

Increasing dwell time can improve tablet production.

API can be mixed with silicone and other polymers to create drug-delivery combination products.

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.

Bosch Packaging Technology’s GKF 720 capsule filling machine for small batches of hard capsules uses a fully automated, washable containment process.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

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