Manufacturing

A new, robust method for protein elution from ceramic hydroxyapatite.

PDUFA renewal legislation sets stage for new policies affecting revenue, resarch, and oversight.

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

A report commissioned by FDA evaluates the QbD program.

Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.

Growth and change in Brazil and Mexico offer key opportunities for the region's pharmaceutical industry.

The author offers perspectives on ways in which pharmaceutical companies and other stakeholders in the supply chain can confront the threat of counterfeit products, cargo theft, illegal diversion, and economically motivated adulteration.

Smartphones could become the product-authentication tool of choice. Contains online bonus material.

Might European officials reverse their position on acceptable production methods?

International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.

Industry buy-in is increasing as pharma companies proceed with select projects and research.

New product reviews for September 2011 focusing on manufacturing.

The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.

Biocatalysis, chemocatalysis, and other chiral technologies continue to attract the investment dollars of CMOs and fine-chemical companies.

The rising cost of healthcare has complicated the introduction of new, innovative drugs and other medical technologies. While the medical impact of these healthcare advances cannot be denied, governments and healthcare policy makers have found it difficult to sustain the funding of these expensive treatments.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.

As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.

By introducing a Patent Box scheme that offers reduced taxes to innovative companies, the UK government hopes to encourage investment in the country.

A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

Henrik Schwartzbach, senior process technologist at GEA Niro, explins why spray drying is seeing increased uptake in the pharma industry.

A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.