Manufacturing, Biologic Drugs

USP promotes horizontal standards for biologics' quality attributes.

FDA Approves the Influenza Vaccine Formulation for the 2011-2012 Flu Season.

The author describes recent developments to help overcome the downstream processing bottleneck. This article is part of a special issue on Sterile Manufacturing and Bioprocessing.

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.

Novartis has completed the acquisition of a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. — one of the largest privately held vaccines companies in China.

Novartis acquired a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical, one of the largest privately held vaccine companies in China. The acquisition gives Novartis an expanded presence in the Chinese vaccine market and will facilitate the introduction of Novartis's vaccines into the country.

Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days.

World AIDS Day 2010 reminds us that prevention and hope can help fight the disease.

The author reviews advances in technology that may soon allow transdermal delivery of two of the fastest growing drug classes on the pharmaceutical market. This article is part of a special Drug Delivery issue.

Drugmakers hatch new manufacturing paradigms in the wake of the 2009 H1N1 influenza pandemic.

A look at MVI's malaria work in developing countries.

Novartis' Matthew Stober discusses vaccine manufacturing, including egg- and cell-based systems.

President Obama and HHS eye innovation and countermeasures to protect public health.

The European Medicines Agency (EMA) has launched a review of GlaxoSmithKline's pandemic influenza vaccine Pandemrix to investigate whether there is a link between vaccination and cases of narcolepsy, a rare sleep disorder.

The President's Council on Advisors on Science and Technology (PCAST), a group administered by the federal Office of Science and Technology Policy (OSTP), issued recommendations to improve the country's ability to accelerate vaccine production and delivery in the event of a pandemic flu outbreak.

US Department of Health and Human Services (HHS) Secretary Kathleen Sebelius released last week an examination of the federal government's system to produce medical countermeasures, or medications, vaccines, equipment, and supplies needed for a health emergency.

Two new reports describe the vaccine market's recent growth and predict future market expansions.

A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010.

The authors describe recent market trends and indicate the likely future direction of the pharmaceutical and biopharmaceutical industries. This article is part of the 2010 Outsourcing Resources special issue.

Why the primary defence against biosimilars is to develop better molecules that can be launched quickly.

Researchers claim that a dissolving microneedle patch may be able to offer improved vaccination against influenza compared with traditional needles, and also allow people without medical training to easily and safely administer the vaccine.

A new automated factory in Boston (MA, USA) has been developed that uses non-genetically modified green plants to quickly produce large quantities of vaccines and therapeutics.

Growth in the market for monoclonal antibodies, recombinant proteins, and vaccines creates new opportunities for drug companies and suppliers.

Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain - traditionally produced vaccines take approximately 6 months.

Florian Krammer explains how a novel technology using insect cells can accelerate the manufacture of pandemic influenza vaccines.