Manufacturing, Biologic Drugs

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

No evidence that Fluad vaccine caused deaths in Italy, says EMA.

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

Johnson& Johnson is collaborating with WHO and others on clinical testing, development, production, and distribution of an Ebola vaccine.

IDT Biologika completes large-scale biologics finishing facility in Dessau, Germany.

NIH seeks new therapeutic products to bolster the protective properties of vaccines.

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

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

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

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

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

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

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.

New formulations and expanded vaccine production are encouraged.

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

Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

HHS plan makes progress in ensuring availability of safe vaccines.

EMA releases an update on its flu vaccine guidance.

MedImmune has entered into a research collaboration with Immunocore to develop novel cancer therapies.