News

With a $5 million grant from DARPA, DNA Script and Moderna will develop a prototype for rapid mobile manufacturing of vaccines and therapeutics as part of the DARPA’s Nucleic Acids On-Demand World-Wide program.

Sanofi will perform the fill/finish of up to 200 million doses of Moderna’s COVID-19 vaccine at its Ridgefield, NJ, facility starting in September 2021.

Samsung and TG Therapeutics have expanded their 2018 contract manufacturing deal for the supply of TG’s ublituximab, an investigational anti-CD20 monoclonal antibody.

Since launching the partnership, Evotec and Bristol Myers Squibb have established a pipeline of novel first-in-class targeted protein degradation projects, two of which have transitioned into lead optimization.

DCAT’s annual bio/pharmaceutical development and manufacturing business event, DCAT Week, will take place virtually from July 12–16, 2021, with the in-person even postponed to March 20–24, 2022 in New York City.

The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.

Lipid production at Evonik’s Hanau, Germany, site was set up in eight weeks and met high-quality requirements, accelerating delivery time, which was originally set for mid-2021.

DFE’s new line will offer market purity and low endotoxin excipients for use in formulation, while providing drug developers and manufacturers high-quality excipient technology and services.

Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.

Vertex and CRISPR have amended their collaboration agreement to include the development, manufacture, and commercialization of CTX001, an investigational CRISPR/Cas9-based gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia.

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 FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

The new facility, which will be Evotec’s first in Europe, will aim to offer capacity, flexibility, and quality for biotherapeutic development and manufacturing while utilizing technology that employs small, automated, highly intensified, and continuous bioprocessing operations inside autonomous cleanrooms.

CalAmp's new sensor for cold-chain applications provides visibility for shipping vaccines.

FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility.

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.

CordenPharma’s expansion will include the addition of new production lines which will be merged into the lipid manufacturing process in April 2021.

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

The acquisition, which is expected to be completed by the end of 2021, will give Thermo Fisher access to PPD’s drug development platform, patient recruitment capabilities, and laboratory services.

The new Abzena facility will initially include four modular suites with up to two 2000-L bioreactors, followed by the addition of two more 2000 L suites.

Catalent plans to add cryogenic capabilities to its facility in Philadelphia, which will strengthen its ability to cryogenically preserve cell therapies and other biological materials.

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

The ATMPS and Ori Biotech collaboration aims to improve visibility and reporting of cell and gene therapy manufacturing through a pre-integrated data solution.

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.

Through the agreement, Lonza will use its fully integrated end-to-end program, Ibex Design, to manufacture cGMP material for the mAb while supporting the process from gene to IND.