 Washington Editor, jillwechsler7@gmail.com.

Articles

The White House sent Congress a summary of “topline” funding requests that continue efforts to combat the coronavirus pandemic and to restore the nation’s economic health.

Biden Seeks Added Funding for Medical Research and Disease Tracking

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.

Vertex Pharmaceuticals and CRISPR Therapeutics Amend Agreement for $1.1 Billion

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.

Waters and Genovis to Collaborate on Biopharmaceutical Characterization Workflows

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.

FDA Unveils Extensive Manufacturing Violations at Emergent

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.

Evotec Launches Biomanufacturing Facility in France

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

CalAmp Launches End-To-End Supply Chain Visibility Solution for Cold Chain

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

FDA Shuts Down Emergent Vaccine Facility

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

Emergent BioSolutions Pauses Vaccine Manufacturing 

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.

Pfizer and BioNTech to Supply EU with 100 Million Additional COVID-19 Vaccine Doses

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

FDA Revokes Emergency Use Authorization for COVID-19 Treatment

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

CordenPharma to Expand Lipid Purification Capacity at its Colorado Site

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

Sartorius Opens New Downstream Center of Excellence Facility in UK

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

FDA Weighs in on Remote 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.

Thermo Fisher to Acquire PPD for $17.4 Billion

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.

Abzena Names North Carolina Location for New GMP Manufacturing Facility

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.

Catalent to Add Cryogenic Capabilities to Support Cell and Gene Therapy Development

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

Hyalo Technologies Unveils Room Temperature Drug-Stabilizing Technology

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

ATMPS and Ori Biotech Collaborate on Integrated Digital Platform for Cell and Gene Therapy

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.

Leadership Change at CDER Spotlights Imperative to Name New FDA Commissioner

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.

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