Manufacturing

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.

The United States Pharmacopeial Convention is recalling USP 33?NF 28.

Many life-sciences companies are likely to execute an acquisition in the next 12-24 months, according to a survey by Ernst & Young.

Influenza vaccines can be produced faster using a new insect cell-based technology compared with traditional egg-based processes, according to scientists in Vienna (Austria).

Zydus Cadila, a pharmaceutical company based in Ahmedabad, Gujarat, India, will begin conducting trials for a H1N1 vaccine.

On Jan. 4, 2010, Novartis (Basel) and Nestlé began completing their 2008 agreement, under which Novartis will acquire Nestlé's remaining 52% stake in eye-care company Alcon (Hünenberg, Switzerland).

Bioject Medical Technologies establishes alliance with MPI Research; Biogen Idec CEO to retire; And More.

Microelectronics offers "striking opportunities" for advancing biomedical research and creating new markets for the medical sciences industry.

This study used biological indicators containing Geobacillus stearothermophilus spores and a new technology to continuously monitor incubated BIs and record nonsterile results.

A comprehensive book about mass transfer benefits from the author's personal touch.

Team leaders in FDA's Office of Generic Drugs provide an overview.

Plus, novel dosage forms and emerging trends.

The authors describe the implementation of an on-line particle-size analyzer on an active pharmaceutical ingredient milling operation at a commercial site.

From healthcare to corruption to life expectancy, here's what we can learn from the past decade.