Formulation and Drug Delivery

The author reviews the challenges in delivering macromolecule biologics.

Measuring syringe plunger force using a texture analyzer instrument.

This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.

The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.

Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.

Sigma-Aldrich's custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.

Bristol-Myers Squibb announced that they have reached an agreement with F-star Alpha, giving BMS the exclusive option to acquire F-star's HER2-targeted breast and gastric cancer treatment.

The divestment will create the number two player in the global influenza vaccine industry.

GSK's investigational Ebola vaccine is in Phase I safety trials.

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

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

Manufacturers using highly potent APIs must examine cross-contamination routes and determine acceptable limits.

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

The total market for biopharmaceuticals in 2013 was $36.8 billion according to Kalorama Information. Meanwhile, Frost & Sullivan estimates that the biosimilars market, which it pegged at just $1.2 billion in 2013, will grow to $23 billion in 2019, or more than 20-fold increase.

Pharmaceutical Technology Europe spoke with Piero Iamartino, R&D director at Micro-Macinazione, about the role of micronization in pharmaceutical manufacturing.

LABOCHIM SpA completes construction on multipurpose high-potent API plant in Milan.

Demand for new therapies and vaccines spotlights production challenges.

Weighing the pros and cons of hot-melt extrusion and spray drying.

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

Advances in solid and liquid formulation techniques are providing more options.

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

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

USP expresses its support for a consensus-based global approach to the naming of biologics.

Formulation will utilize Catalent?s OSDrC OptiDose multicore drug-delivery platform.

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.

Micronization and other processes are used to obtain optimal particle characteristics for pulmonary and oral solid-dosage delivery.

A GPhA report says generic drugs saved the US health system $239 billion in 2013.

Molecular Profiles has expanded its capsule filling capability following significant investment into new equipment at its clinical manufacturing site in the United Kingdom.

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