Manufacturing

Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.

The company will supply its heparin sodium injection in prefilled syringe form.

The new program, Cornerstone, integrates process development expertise and novel technology to remove development bottlenecks in the manufacture of gene therapy medicinal products.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

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 company’s Custom Single Run product line now has available bioreactors with working volumes of up to 6000 L.

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.

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 joint venture, named BacThera, will operate out of headquarters in Basel, Switzerland and will serve pre-clinical to Phase II projects, with the ability to expand to Phase III and commercial manufacturing in the future.

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 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.

The editors welcome technical article contributions from biopharma industry experts.

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

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

A collaboration between Insilico Biotechnology and IFAT aims to develop a manufacturing, planning, and control system for the production of monoclonal antibodies.

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

A new defined coated cell cultureware by denovoMATRIX allow for the serum-free expansion of mesenchymal stem cells.

The partners will collaborate to identify the bioactive components in hydrolysates, which have long been used as additives in cell culture media and feed formulation in the biopharma industry.

GSK will handle the development, regulatory, commercialization activities, and costs of the drug, while Ionis will obtain license fees and milestone payments of up to $262 million, including a $25 million license fee.

The new vaccine will offer protection against the Nipah virus after a single dose.

Innovate UK has awarded a grant worth thousands to the Atelerix Consortium for the collaborative work with the Cell and Gene Therapy Catapult and Rexgenero on development of cell stabilization technology.

The agreement gives Biotheus access to Alligator’s antibody, Alligator-Gold, for the creation of up to three bispecific molecules.

Pfizer is investing $500 million for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, NC.

The Birtley, UK facility added cleanroom, manufacturing, and testing facilities for biopharma manufacturing single-use systems.

Optima Pharma opened a new assembly hall, the CSPE Center, that will give the company space to build complete, multi-story pharmaceutical manufacturing facilities.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.