Manufacturing

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

An optimal engineering design is crucial for aseptic operation and cleaning.

Successful migrations require careful planning to meet business needs and maintain data integrity.

Consider modular automation and cybersecurity when modernizing manufacturing processes.

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

The CountQ system from Verista automates accurate counts of tray-loaded parts, including vaccine vials.

Edge-AI technology will enable Industry 4.0 automation in pharmaceutical manufacturing.

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

Automation and tools for remote monitoring are finding increased use as pharmaceutical manufacturing adapts to pandemic restrictions.

The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.

The new VirusExpress lentiviral production platform increases dose yields and reduces process development time for cell and gene therapies.

The new facility at the company’s San Diego, CA, site will be for late phase and commercial CGMP manufacturing.

Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.

FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.

Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.

Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic.

The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.

Research is striving to make pharmaceutical processes more scalable by making them simpler and easier to replicate and control. Advances include 3D printing, as well as miniaturized and continuous processes, all of which are being aided by improved automation and analytics.

The manufacture of gene therapy vectors is shifting to more modern technologies.

Industry experts discuss challenges and best practices for scaling up manufacturing under a short deadline.

A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.

Facility and equipment design are important, but the team and its experience matter most.

End-to-end traceability can provide more value than just securing drug product safety.

Cellular and gene therapy fields are currently on track for, if not already experiencing, a serious capacity crunch.

The ROSS VMC-1000 VersaMix is a 1000-gallon triple-shaft mixer available on a pivot-design single-post hydraulic lift.

Recipharm and BIAL have expanded their long-term supply agreement for the global manufacture and supply of opicapone API.

The technology is a novel, plasmid-free manufacturing system for robust and reproducible manufacture of AAV at scale.