Manufacturing

Both upstream and downstream processes can benefit from continuous manufacturing advantages.

Tony Wright, CEO of Exelsius Cold Chain Management, answers questions about the new requirements for temperature-controlled pharmaceutical distribution.

Doug Hausner, Engineering Research Center for Structured Organic Particulate Systems, Rutgers University discusses continuous manufacturing for solid-dosage drug production.

The author discusses various aspects of the hot-melt extrusion process and outlines a practical approach to scale-up.

The authors describe how modular systems can be applied to continuous solid-dosage and nutraceutical manufacturing.

Charlie Martin, Leistritz Extrusion, describes hot-melt extrusion manufacturing processes and advances.

The author examines the effect of compaction force, gap width, and sieve setup on granule size.

The selection of excipients is important in generic formulations due to the impact it has on the risk and performance of generic drugs.

The AdvantaPass wall pass-through system from AdvantaPure permits aseptic transfer of fluids between suites.

A universal Milling Isolator from Powder Systems Limited (PSL) handles multiple mills.

FDA develops an assay that could speed the release of pandemic influenza vaccines.

A patented cartridge using fast-drying inks allows high-resolution coding for pharmaceutical packaging.

The Purifier Logic+ cabinet from Labconco provides a safe and comfortable work environment.

Dalton Pharma completes its $2.5 million expansion in Toronto for sterile and aseptic filling capabilities.

EDQM has launched a database, Know-X, which collates reports on counterfeit/falsified medical products that have been detected in Council of Europe member states.

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

SyncOperations Software Helps Increase Workflow

A new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.

New identifiers and tracking requirements aim to block illegitimate products.

Methods of validating and assuring container closure integrity are crucial for quality assurance.

Arc View Handheld Mobile Sensor Enhances Measurements

CLARiSUITE Software Improves Accessibility and Productivity

Multirobot Offline Programming Software Allows 3-D Simulation