Manufacturing

The deal expands Wavelength’s drug substance manufacturing footprint and its API CDMO business.

Through the agreement, Catalent will manufacture LUPKYNIS (voclosporin), Aurinia’s drug for the treatment of adult patients with lupus nephritis, at its pharmaceutical softgel center of excellence in St. Petersburg, FL.

Cascade began production on new facilities to manufacture APIs for clinical and commercial GMP production.

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

The increased services will work in conjunction with the site’s SimpliFiH Solutions first-in-human services, which includes phase-appropriate drug substance and drug product development and manufacturing.

The US government will pay $1.95 billion for the additional 100 million doses, bringing the total number of doses supplied by the companies up to 300 million.

Integration of Brooks Life Sciences BioStore III automated storage and inventory monitoring solution with Cytiva’s Chronicle software will improve traceability, process control, and monitoring capabilities.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.

Labeling, printing, and on-dose tagging technologies provide a multi-layered approach to anticounterfeiting for pharmaceuticals.

The new business services site will house the company’s North American human resource operations, along with certain finance and information technology teams.

Evonik has revealed plans for investment in the short-term expansion of its specialty lipids production, which are used with mRNA-based COVID-19 vaccines.

The companies will build capacity in Germany that will be ready in 2022 and are exploring options for increasing volume in 2021.

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

How can artificial intelligence and machine learning be used to gather and process real-time manufacturing data?

Model-based approaches and digital analytics are improving flexibility at both the equipment and the manufacturing-line level.

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

As demand for COVID-19 vaccines increases, Big Pharma offers its manufacturing capacity and expertise.

Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches.

Advanced manufacturing technologies are available, but challenges need to be addressed.

Sharing process insights across the stages of drug development improves tech transfer.

Anticounterfeiting technology protects the supply chain from manufacturer to patient.

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.