Manufacturing

John Kelly, vice-president of strategy and transitioning sites for Pfizer Global Supply, discusses the company's manufacturing and supply strategy and network.

Europe establishes new collaborative system to track products.

AAPS Global Health Focus Group's Kishor M. Wasan discusses new initiatives.

Single-use components in the fill–finish line provides increased flexibility to multiproduct manufacturers.

Drugmakers and packagers are pursuing various initiatives to reduce their carbon footprints. This article contains bonus material.

Getting the most value out of M&As requires proper upfront legwork.

Corporate management must be held accountable for quality at all levels.

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

Could oral absorption-enhancing technologies change the shape of protein delivery?

The authors describe the concept of the limiting discriminatory the limiting discriminatory threshold (LDT) as an objective means of evaluating the inherent quality requirement of a large-sample content-uniformity test.

The authors summarize a recent FDA–PQRI workshop on process drift.

A Q&A with Rao Tatapudy, vice-president of scientific affairs at Catalent, on recent industry trends.

Letting contamination build up can cause multiple headaches.

In an effort to balance bilateral trade, India is urging China to increase Indian pharmaceutical imports.

New product reviews for October 2011 focusing on analytical instrumentation.

Manufacturers fund research and reduce prices to tackle diseases.

The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.

Despite new hurdles, industry must move forward and fulfill its mission.

This risk-management case study focuses on assessing empty capsules.

In a quick-fire interview, Dr Stephen Taylor, Vice President & Commercial Director at Fujifilm Diosynth Biotechnologies, looks at some of the challenges facing biologics outsourcing.

GlaxoSmithKline (GSK) is looking to racecar technology as it seeks to improve its manufacturing, R&D, and consumer-healthcare areas. The company has formed a long-term partnership with the UK-based McLaren Group, which is best known for its expertise in the Formula 1 motor sport.

GE Healthcare, the health business of General Electric, will dedicate $1 billion of its total R&D budget during the next five years to its technologies for manufacturing biopharmaceuticals and for cancer research. Part of the money will go toward expanding the company's cancer-diagnostic and molecular-imaging capabilities, as well.

President Obama released his plan for deficit reduction on Sept. 19, 2011, and included in the 80-page report are several provisions that would affect US drug makers if enacted.

In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2011 edition from Lechler and National Bulk Equipment.