Vaccine Development and Manufacturing

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.

Demand for new therapies and vaccines spotlights production challenges.

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

New formulations and expanded vaccine production are encouraged.

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.

Review regulatory requirements and the use of viral-challenge studies in drug development.

HHS plan makes progress in ensuring availability of safe vaccines.

EMA releases an update on its flu vaccine guidance.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

PhRMA report reflects robust R&D in vaccine development.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

Creating an effective nucleic acid-based vaccine requires protecting the fragile nucleic acid from degradation, effective transfection of the targeted cells, and producing high enough levels of antigen to evoke a robust immune response.

Marco Chacon of Paragon Bioservices discusses the challenges associated with outsourced vaccine manufacturing.

The authors describe a validation master plan for closed-vial filling technology.

Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.

The role of TLR agonists has expanded, and now the molecules can be found in a variety of non-vaccine therapeutics.

The global head of technical operations at Novartis talks about new technologies for vaccine development and manufacturing.

Safety concerns remain for developing replicating vectors based on the pathogen human immunodeficiency virus type 1.

Virosomes present novel drug-delivery vehicles with distinct advantages over liposomes.

Release testing involves both standard potency assays and unique assays (particle size, NA activity) developed to ensure the physical, chemical, and biological stability of this type of vaccine.

Adjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).

Filterability and bacterial retention must be verified very early in process development to ensure successful sterilizing filtration validation.