Manufacturing, Biologic Drugs

CALIXAR Collaborates with VirPath to Develop H1N1 Vaccine

September 23, 2014

CALIXAR and VirPath use new manufacturing techniques to create a vaccine for the pandemic flu, influenza A (H1N1), available in 2015.

Pandemic Vaccine Facility Dedicated in Texas

September 19, 2014

Texas A&M dedicates national pandemic influenza vaccine manufacturing facility.

FDA Approves Phase 1 Clinical Trials for NewLink Genetics' Ebola Vaccine

September 05, 2014

FDA gives NewLink Genetics approval to proceed to Phase 1 clinical studies of Ebola vaccine.

Pfizer to Acquire Vaccines from Baxter

July 30, 2014

Pfizer announced an agreement to acquire Baxter International?s marketed vaccines for $635 million.

GSK Submits EU Regulatory Filing for Malaria Vaccine Candidate

July 29, 2014

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

Arecor and CPI Partner to Enhance Biologics' Compatibility with Containers

June 18, 2014

Arecor and the Center for Process Innovation (CPI) Biologics are working on a project to enhance the compatibility of biologics with their containers.

Research Firm Predicts Negative Impact of Biosimilars

June 12, 2014

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

Determining Protein Oxidation Induced During Fill-Finish Operations

May 15, 2014

The effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.

Demand for New Vaccines Spurs Innovation

May 02, 2014

New formulations and expanded vaccine production are encouraged.

FDA Develops Alternative Assay to Increase Availability of Influenza Vaccines

April 10, 2014

FDA develops an assay that could speed the release of pandemic influenza vaccines.