Manufacturing, Biologic Drugs

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

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.

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

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

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.

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).

GlaxoSmithKline (GSK) has agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

Last week, GlaxoSmithKline (GSK, London) agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

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The European Medicines Agency, the European Center for Disease Prevention and Control, and the Heads of Medicines Agencies issued a European strategy for H1N1 vaccine benefit–risk monitoring.

GlaxoSmithKline (GSK), Novartis, sanofi aventis and Baxter International have provided updates regarding the development, manufacture and shipment of pandemic (H1NI) vaccines.

A long-term joint venture between GlaxoSmithKline (GSK) and China's Jiangsu Walvax Biotech Company hopes to develop and manufacture paediatric vaccines for use in China.

On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria.

A joint venture between a charity and a pharma giant has led to the creation of the Hilleman Laboratories, which will use a not-for-profit operating model to develop and deliver vaccines to low-income countries.

The FDA has approved four vaccines for the H1N1 influenza virus, while other companies, including UK pharma giant GlaxoSmithKline (GSK), have reported promising results from clinical studies with a single dose vaccine.

Now expected to obtain its production license during the next few days, an H1N1 vaccine developed by Sinovac Biotech (China) has passed the experts' evaluation by the Chinese State Food and Drug Administration (SFDA).

The Czech Republic will no longer purchase the H1N1 flu vaccine from Baxter International.

Scientists have modified a tobacco plant to produce a vaccine for norovirus, the viral infection sometimes referred to as the "cruise ship virus".

The authors describe a proprietary process for producing a stable, topical interferon alpha-2b formulation that can deliver large drug molecules into the skin or mucosa.

The authors discuss how strategic outsourcing to contract manufacturing organizations that have technical and regulatory expertise can add further value during vaccine development.

The United States Department of Health and Human Services (HHS) this week placed an initial order with Sanofi Pasteur (Lyon, France) for a vaccine to fight influenza A (H1N1) infection.

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Scientists are giving up on a preventive vaccine for AIDS, but there are lessons to be learned.

Merck & Co. initiated a voluntary recall of 11 lots of its Haemophilus influenzae type B vaccine, Pedvaxhib, and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, Comvax.