Manufacturing

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

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.

EU Issues Strategy for Influenza A (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.

Pandemic flu vaccine projects continue to make progress

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

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.

Joint venture to provide paediatric vaccines to China

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

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.

EMEA Recommends Two H1N1 Vaccines for Authorization

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.

Vaccines for 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.

Single dose H1N1 vaccines get FDA OK

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).

One-shot H1N1 vaccine gets Chinese thumbs up

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

Czech's reject Baxter flu vaccine

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

Tobacco plant helps produce norovirus vaccine

Kim Gaspar, PhD, is manager of quality assurance at Helix BioPharma.

Jinghui Shen, B. Eng., is an analytical chemist at Helix BioPharma.

John Docherty, M. Sc., is president and chief operating officer at Helix BioPharma.

Ravinderjit Batta, M. Pharm., is group leader of formulation development at Helix BioPharma.

Geriene LaBine, M. Sc., is head of quality control at Helix BioPharma.

Praveen Kumar, M. Pharm. and PhD, is vice-president of topical drug product development at Helix BioPharma, 301â111 Research Drive, Innovation Place, Saskatoon, Saskatchewan, Canada S7N 3R2, tel. 306.934.7471 ext 230, fax 306.934.7453.

Marianna Foldvari, D. Pharm. Sci. and PhD, is Canada research chair in bionanotechnology and nanomedicine and associate director of research and graduate studies at the School of Pharmacy, University of Waterloo, Ontario, Canada.

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.

Manufacturing, Biologic Drugs