Formulation and Drug Delivery

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

Member of parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.

Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.

WuXi's new facility in Philadelphia will manufacture CAR T-cell therapies and other cancer immunotherapies.

Penn Pharma's equipment addition meets growing need for continuous dry granulation and for handling of highly potent drugs.

Innovative equipment, analytical techniques, software, and modeling systems are improving the tableting process.

Taste may be subjective, but it is crucial to patient compliance, particularly for pediatric treatments.

Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.

PAT has aided formulation, both pre-and post-filing, by reducing costs and time frames.

Ionic liquid technologies offer a new way to improve bioavailability.

New cellulosic polymers have been shown to improve solubility in these key amorphous solid dispersion processes.

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

Mallinckrodt Pharmaceuticals has bought Ikaria, a privately-held critical care company, for $2.3 billion.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.

Baxter has bought SuppreMol, a German biopharmaceutical company that focuses on autoimmune treatments, for €200 million ($225 million USD).

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

A facility expansion adds space for production of Repligen’s tangential flow system.

Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.

Richard Grant, Global VP of Cell Therapy at Invetech discusses the advantages and challenges of developing and manufacturing personalized immunotherapies.

The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.

While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.

Protecting workers, patients, and the environment requires advanced technologies.

While the skin offers an alternative route of administration for local and systemic drug delivery, developing semi-solid dosage forms can be a challenge.