Manufacturing

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.

COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.

ROSS incorporated a high shear rotor/stator into its Dual-Shaft Mixer to meet more intense shearing and homogenization requirements.

The companies previously entered into a collaboration in November 2020 with the goal of producing more than 100 million doses of the CureVac vaccine per year at Rentschler’s Laupheim, Germany facility.

WuXi STA will acquire the site’s operations and assets, including the plant, equipment, and workforce.

From scale-up and tech transfer to analytical method development and quality testing, alliances between innovators and contract partners, and between CDMOs and technology vendors, are taking more therapies from lab to patient.

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

For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

Contract development and manufacturing organizations provide vital services to rush COVID-19 vaccines to patients.

Bayer will support CureVac by providing the company with further development, supply, and territory operations via its clinical operations, regulatory affairs, pharmacovigilance, medical information, and supply chain management expertise.

The vaccine will be developed using Gritstone’s proprietary prime-boost vaccine platform, which includes self-amplifying mRNA and adenoviral vectors, with antigens formulated by Gilead.

Cytiva acquired Vanrx Pharmasystems, a Canadian manufacturer of robotic aseptic filling equipment.

A contract from the US government will help fund domestic US production of small-molecule APIs and finished dosage forms and will be the first GMP facility using ICM technology.

The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.