Manufacturing

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.

Keiji Fukuda, special adviser on pandemic influenza to the World Health Organization's (WHO) director-general, told a hearing at the Council of Europe that WHO's response to the influenza (H1N1) pandemic was not improperly influenced by the pharmaceutical industry.

Lonza Group (Basel) plans to reinforce its presence in Asia, including its platform in Nansha, China, and to close its Conshohocken (Riverside), Pennsylvania; Shawinigan, Canada; and Wokingham, United Kingdom, sites in 2010.

FDA Issues Warning Letter To McNeil Healthcare; Charles River Laboratories Will Suspend Operations At Massachusetts Facility.

McNeil Consumer Healthcare is voluntarily recalling certain lots of over-the-counter products in the Americas, the United Arab Emirates, and Fiji.

Could flexible manufacturing change the standards for biopharmaceutical production? To find out, Equipment and Processing Report talked to James Robinson, vice-president of technical and quality operations at biotechnology company Novavax (Rockville, MD).

The authors sought to improve the productivity of protein synthesis by using a highly active cell-free extract from Escherichia coli and by optimizing buffer conditions and shaking conditions.