Manufacturing

FDA's requirements for API manufacturers in regards to ICH Q7.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

QbD paradigm advances process understanding in development and manufacturing.

New product reviews for March 2013, featuring automation, IT, and process control systems.

Vaccine development is benefiting from manufacturing advances and support for global health.

The authors review developments in wet granulation using a twin-screw extruder.

Recent advances in equipment design and operation in spraying, drying, and mixing can improve the tablet-coating process.

The tableting science anti-research (TSAR) project seeks to understand why certain formulations stick to tablet tooling.

A roundtable discussion of the challenges and innovations in tablet splitting featuring Freeman Technology, Accu-Break Pharmaceuticals, and Medelpharm.

An alternative chapter has been added to the European Pharmacopoeia for dosage uniformity.

Equipment purchased today for the packaging line should be serialization-ready in preparation for upcoming requirements.

A Q&A with Michael Lacey, plant manager at the National Institute for Bioprocessing Research and Training.

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

Engineering groups at Rutgers and MIT constructed solid-dosage continuous manufacturing lines and transferred the technology to pharmaceutical industry partners.

Protein Sciences announced that the Biomedical Advanced Research and Development Authority (BARDA) will continue to support the company?s influenza vaccines program.

In the era of manufacturing capacity rationalizaton, tighter return on assets, and re-alignment of manufacturing assets to meet changing product demand, strategies for cost-effectively managing manufacturing and other facilities become ever-more crucial. A Q&A with UMS Advisory.

FDA has released a list of more than 50 guidance documents planned for 2013.

Medication safety and efficacy depend on maintaining products at the proper temperature.

The share of biologic-based drugs in the global pharmaceutical market is on the rise.

Quality assurance of biological products is central to India's good distribution practices guidelines.

Measuring the rouge corrosion rate can help determine when a system should be cleaned so the final product is not impacted

A thorough investigation of all possible causes of deviations should be performed.

Eastern Europe is moving towards a goal of harmonized regulations.

The minimum amount of residue that can be visually detected is demonstrated for a small number of active pharmaceutical ingredients (APIs) on a range of different surface materials.

New product reviews for February 2013.