Manufacturing

Margaret Hamburg, commissioner of the US Food and Drug Administration, unveiled a new program to improve the efficiency of import inspections.

VaxGen Shareholders Reject OXiGENE Merger; Roche Creates Research Hub In Singapore; And More.

GSK launched a stand-alone unit that will specialize in the R&D and commercialization of medicines for rare diseases.

A highly functioning New Product Planning (NPP) group is a company's first line of defence against losses caused by products that fail to reach the market, according to research and consulting firm Best Practices LLC.

Pfizer's first updated pipeline since its acquisition of Wyeth includes fewer projects than before and is targeted to specific diseases.

Cephalon Buys Mepha; BASi's CEO Retires; and More.

AstraZeneca announced this week that it plans to undertake further restructuring in its research and development operations, resulting in the elimination of 3500 jobs.

Hoping to prevent the deaths of eight million children over the next decade, Bill and Melinda Gates recently committed $10 billion for child-immunization programs in the world's poorest countries.

Strategic rather than tactical considerations are driving biopharmaceutical outsourcing.

Sharing too much-or too little-information can have disastrous onsequences.

FDA impersonators and counterfeit drugs threaten the public's trust in online pharmacies.

Editors' Picks of Pharmaceutical Science & Technology Innovations

A look at the formulation challenges in pancreatic enzyme products.

Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.

Regulators and industry move to require inspections of API manufacturing facilities.

When it comes to healthcare rform, we must not overlook investment in innovative technologies.

How to cut time and cost by re-using already submitted documents.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.

Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.

We never thought implementing complex changes could become more cumbersome.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

Although once used only for large production processes, robotics are now working their way into every aspect of the pharma manufacturing processes.

There is much scientific evidence of the early successes of whole cell therapies as disease cures in chronic conditions and disease-modifiers in acute conditions, but limited cases of successfully transferring these discoveries to commercial products or therapies.

Pharmaceutical Technology Europe discusses some of the latest challenges and innovations that are expected to define the future of pharma.

PEGylation has been around for 30 years and it is surprising that it is still widely used given the significant advances that have been made in biopharmaceutical manufacture since then. So why is this the case?

Last year, the UK's National Institute for Health and Clinical Excellence (NICE) decided that a new biopharmaceutical cancer drug costing £3000 per month, which could extend a patient's life by 6 months, was not value for money and would not be prescribed in the UK.

The whole pharma/biopharma industry is under pressure to deliver cost-effective new drugs; however, the number of new drug applications is getting lower as the size of investment is increasing.

The vaccine sector is challenging for both R&D and manufacturing because a wide variety of technologies and techniques are required — even the largest companies find it difficult to cover all the relevant areas of expertise — and this drives up development costs and often forces companies into multiple collaborations to obtain the required expertise and technologies.

Maintaining asepsis and sterility is the primary challenge to implementing aseptic techniques and sterile processes in biopharmaceutical manufacture. Efforts to reduce the risk of microbial contamination of aseptically filled biotech products beyond their already low level represent engineering challenges, that don?t really compliment the progress in biotech R&D.

Novartis CEO To Step Down; DSM To Close Netherlands Facility; And More.