Formulation and Drug Delivery

The companies have engaged in a manufacturing scale-up of LTX-03 tablets for clinical testing using LIMITx Technology.

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.

The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.

In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.

Valo Therapeutics has acquired a technology from Helsinki University that is expected to broaden its approach and expand the capability of its cancer vaccines platform, PeptiCRAd.

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.

The partnership will provide cost effective biologics for the world market.

A global agreement with Polpharma Biologics gives Sandoz commercialization rights to a proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.

In this interview, the main uses and benefits of NIR spectroscopy in tableting are discussed.

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.

Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.

Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

Medical researchers from the Centenary Institute and the University of Sydney in Australia have managed to successfully develop and test a new vaccine targeting tuberculosis.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

ABPI has issued a statement of support in response to the United Kingdom’s Prime Minister’s recent order of urgent action to boost the numbers of children receiving vaccinations.