Biologic Drugs in Development

While falling short of the 2018 record levels, US drug approval numbers continue to set the pace globally.

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.

The agreement paves the way for GSK’s specialty HIV company, ViiV Healthcare, to develop a broadly neutralizing antibody, N6LS, for HIV treatment and prevention.

The companies have entered into a clinical and commercial agreement to use MaxCyte’s ExPERT platform to enable development of up to five of Vor’s engineered cell therapies.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an alternate approach for commercial production.

The use of scale-down models allows for the theoretical optimization of processes and for troubleshooting problems during the developmental stage.

On Tuesday, Nov. 5, 2019, Karima Yadi from Becton Dickinson & Co. will present the challenges of using, and necessity for, shorter needles and integrated systems with high viscosity drugs, such as biologics, to improve the patient experience at CPhI Worldwide.

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.

The new services provide rapid production of antibody drug conjugates (ADCs) for best candidate selection.

The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.

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

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

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.

Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.

Bayer will use ProBioGen’s GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.

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.

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

In an effort to secure a continuous, sustainable supply of an important vaccine ingredient, Agenus is turning to a plant cell-based cell culture method for production.

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