Manufacturing, Biologic Drugs

Rockville, MD (May 31)-The US Food and Drug Administration finalized guidances for seasonal and pandemic influenza vaccines, outlining the regulatory pathways for developing and approving these products.

Acambis, FDA, Biogen, Ranbaxy, more

Geneva, Switzerland (Apr. 27)-A meeting of the World Health Organization and the Committee for Medicinal Products for Human Use's approval of Novartis's new cell culture-derived influenza vaccine offered new hope that sufficient numbers of vaccines could be produced in case of a pandemic.

Interphex2007, New York, NY (Apr. 25)-As governments begin to contemplate the possibility of biological terrorism or a pandemic event, a new problem begins to emerge: in the case of a pandemic or an attack, even if a vaccine or treatment exists, how could it be produced in sufficient numbers to prevent the deaths of millions of people? That question was addressed in at the conference session, "Responding to Bioterrorism and Pandemic Events: A Case for Development of Flexible Manufacturing Space for Vaccine Production," at Interphex today.

Lyon, France (Apr. 17)-Sanofi Pasteur, the vaccine division of the Sanofi-Aventis Group, announced that the US Food and Drug Administration has licensed its H5N1 vaccine, making it the first avian-influenza vaccine for humans in the United States.

Aventrx, ImmBio, Eli Lilly, more

Cobra, InterMune, Pall, More

Geneva, Switzerland (Feb. 16)-During a two-day meeting, the World Health Organzation announced ?encouraging progress? in the development of a pandemic influenza vaccine but admitted that the industry still ?lacks the manufacturing capacity to meet potential pandemic influenza vaccine demand.?

Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.

Alcan, China Biopharma, US FDA, MedImmune, more

Geneva, Switzerland (Oct. 23)-Aiming to increase capacity for producing influenza pandemic vaccines, the World Health Organization has identified strategies and practical solutions for reducing the anticipated gap in the global vaccine supply.

New York (Oct. 9)-Pfizer has positioned itself to enter the DNA-based vaccine market with its agreement to acquire UK-based PowderMed Ltd., which holds a pipeline of DNA-based influenza vaccines currently in clinical development for treating both seasonal and avian flu.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

GlaxoSmithKline (London, England) has developed a vaccine against the H5N1 bird flu strain that, the company says, shows better immune response than other vaccines in development.

Novartis (Basel, Switzerland) will build a cell culture-derived influenza vaccines manufacturing plant in Holly Springs, North Carolina. Construction is expected to begin in 2007.

Although the number of anti-infective vaccines (as distinct from therapeutic vaccines for cancers and other noninfectious diseases) entering clinical study each year since 2000 has been higher on average than it was in the 1990s, this product area may see little additional growth through the rest of this decade, according to a recentanalysis from the Tufts Center for the Study of Drug Development (Boston, MA).

MedImmune, Inc. (Gaitherburg, MD) reports that US Food and Drug Administration (Rockville, MD) has approved the company's supplemental biologics license application to use reverse genetics technology to construct new vaccine strains to produce seasonal influenza vaccines.

Biopharmaceutical company Lipoxen PLC (London, UK) has developed a Hepatitis E vaccine using its novel vaccine delivery technology "ImuXen," which the company claims to be easy to manufacture. According to the company, the proprietary liposomal formulation method delivers vaccine materials to the immune system in a manner designed to emulate the response of a natural encounter with the infection agent.

GlaxoSmithKline PLC (GSK, London, UK) will invest more than GBP102 million ($188 million) over the next four years in a vaccine manufacturing plant in Singapore.

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.

Novartis (Basel, Switzerland) has closed on its $5.4-billion acquisition of Chiron Corporation (Emeryville, CA), paving the way for the creation of a new Novartis division focusing on vaccines and diagnostics.

Reverse Genetics Avian Influenza Vaccine Approved in France

GSK Begins Clinical Trials of Two H5N1 Vaccines

Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed.

Progress Continues in Vaccine and Antiviral Development