Manufacturing

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

Washington, DC (June 14)-The US Department of Health and Human Services awarded two contracts totaling $132.5 million to Sanofi Pasteur and MedImmune to retrofit their influenza vaccine manufacturing facilities.

Sanofi Pasteur and MedImmune Awarded Contracts for Flu Vaccine Facilities

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

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.

FDA Issues Guidances on Seasonal and Pandemic Influenza Vaccines

May 31, 2007 Notes: Acambis's Smallpox Vaccine Approved by FDA, Microbix Discovers Vaccine Production-Boosting Manufacturing Process, 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.

New Hope for Worldwide Influenza Vaccine Supply

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.

A Call for Flexible Manufacturing Capacity for Vaccine Production

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.

FDA Licenses Sanofi-Pasteur's H5N1 Vaccine

March 30, 2007 Notes: Pharmatek to Manufacture Oral HIV Medication for Aventrx, Eden to Provide Development and Manufacturing Services for ImmBio's Flu Vaccine Program, More

March 23, 2007 Notes: Cobra Joins Vaccine-Delivery Development Consortium, InterMune to Cut 50% of its Workforce, 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.?

WHO Stresses Lack of Capacity for Pandemic Flu Vaccine

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.

Manufacturing, Biologic Drugs