Pharmaceutical Technology Editors

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

Researchers from the United Kingdom, have identified a new additive manufacturing method that enables the 3D printing of medicine in highly porous structures.

Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.

Solentim has announced the expansion of its European operations, with the establishment of a new entity in Ireland.

Vectura and Inspira Pharmaceuticals have joined forces to develop a potential inhaled therapy for COVID-19.

FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Catalent has acquired Promethera Biosciences’ cell therapy manufacturing subsidiary, which includes a 32,400 ft2 facility in Gosselies, Belgium.

ISPE’s virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency.

FDA has approved AstraZeneca’s Farxiga (dapagliflozin) for treating chronic kidney disease in the United States.

Moderna will double the space at its Moderna Technology Center in Norwood, MA, to transform it from a production and lab space into an industrial technology center.

Cellares has raised $82 million to accelerate the development of its Cell Shuttle, a factory-in-a-box that allows for the automation of the process of creating highly individualized cell therapies.

Moderna has entered into an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine to the 92 Gavi COVAX Advance Market Commitment low- and middle-income countries.

Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

A shortage of pipette tips has been attributed to several factors, including the COVID-19 pandemic.

The company has introduced Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.

This new collaboration between Vyant Bio, Ordaōs Bio, and Cellaria mitigates risk in the drug discovery process using artificial intelligence and in-vitro “avatar” clinical trials.

With new unbiased analysis features and an easy-to-use interface, the CytoML 5.2 uses batch processing to engage a range of parameters used simultaneously for better data representation.

The new ImpactAir-ISO-90 and ImpactAir-90 ranges are designed for use in high-grade areas within the pharmaceutical, healthcare, and specialist food industries where process monitoring of viable particles is necessary.

Eppendorf’s new centrifuge is designed to increase laboratory efficiency, offering advanced features that simplify and accelerate centrifugation steps in the workflow.

AMRI will increase R&D and manufacturing capabilities for orphan and rare disease products.

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space, executing advanced inventory management systems, and adding support areas to supplement capacity.

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

The UK’s Medicines and Healthcare products Regulatory Agency has granted an approval for Vazkepa (icosapent ethyl) to be used as a treatment to reduce the risk of cardiovascular events in high-risk statin-treated adult patients in Great Britain.

The European Medicines Agency and the European Centre for Disease Prevention have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.

ViroCell will supply viral vectors and gene modified cells, to academic and corporate clients, for translational cell and gene therapies going into clinical trials.

Through the acquisition, Pfizer will have access to Amplyx’s lead compound, Fosmanogepix (APX001), an investigational asset under development for the treatment of invasive fungal infections.

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites.

ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.

Under the terms of the agreement, Catalent will handle the process development and CGMP manufacturing of AavantiBio’s adeno-associated viral vector-based therapeutic candidate for use in clinical trials in the US and Europe.

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.