Manufacturing

An industry roundtable representing Metrics, Cambrex, Carbogen Amcis, Euticals, Ferro Pfanstiehl, and SAFC.

This article presents an overview of ISPE's guide on project management.

The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms and APIs of generic drugs.

The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 press release.

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2012 edition from Getinge and MG America.

Service agreements, expert liaisons, and scorecards are important to consider.

Recycling is becoming a viable option for disposal of single-use systems.

A Q&A with Babu Padmanabhan, Managing Director and Chief Knowledge Officer of STEER Engineering, on recent industry trends.

Manufacturers willing to report bad news about the supply can help reverse the shortage trend.

After a series of government reforms that are appealing to both domestic and foreign players, the Japanese pharmaceutical market is making a comeback.

A look at elastomer changeout times shows how industry knowledge improves operations and cost.

Pharmaceutical Technology's annual manufacturing investment update shows slight gains in biopharmaceutical manufacturing and emerging markets and continued restructuring of supply networks.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

The authors compare direct combustion with rinse and swab sampling methods.

Enhancing bioavailability can be achieved through hot-melt extrusion or spray drying. Patricia Van Arnum interviews Bend Research to find out more about when to use each technique.

Highly automated and sensitive quality-control equipment quickly identifies product faults.

IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.

Meticulous system configuration can prevent machines from taking over.

The manufacturing capacity-sharing model in biologics and Merck & Co. and MedImmune ushers in a new paradigm of "co-opetition".

Germany has shifted from a market where the pharmaceutical industry could enjoy considerable pricing freedom to a sensitive market influenced by cost-containment policies.

An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.

The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.

The authors highlight costs, benefits, and implementation success factors across first, second, and third generations of facility management outsourcing contracts.

Annual survey shows strong growth for service providers and promises to continue into 2013.

Dedong Wu, senior scientist at AstraZeneca, explains how nanoparticle engineering and crystal engineering can aid solubility.

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European Union customs in 2011.

MedImmune, the global biologics arm of AstraZeneca, announced that it is restructuring its infectious disease and vaccines R&D and operations. This will result in the closure of MedImmune's sites in Mountain View and Santa Clara, California.

Experts share insights into analytical tools and techniques.