Manufacturing

Industry wants clarification on compliance following the end of the Brexit transition period.

The new line of Defined Tubing Routing (DTR) from High Purity New England is a flexible tubing support system for single-use biopharmaceutical manufacturing.

A virtual ribbon cutting, tour, and panel discussions were hosted on Oct. 29, 2020 to announce the opening of BioCentriq on the campus of the New Jersey Institute of Technology in Newark, NJ.

FDA, US Customs and Border Protection, and the US Immigration and Customs Enforcement, Homeland Security Investigations signed a Memorandum of Understanding to prevent illegal drug imports from entering the US through International Mail Facilities.

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.

Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product.

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 companies have signed a Statement of Intent with Gavi to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine available for distribution.

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.

The company is investing in its Capsules and Health Ingredients Division to expand its capsule production capacity by 30 billion capsules annually.

The 6th-generation Eclipse FFF system handles analytes such as proteins, polymers, viruses, gene vectors, and liposomal drug nanoparticles.

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 lab, which is currently available to customers, can handle highly potent compounds.

The facility will include a high-speed sterile line for live virus filling, a line for standard fill/finish, cleanroom capacity, labs, warehousing, and offices to support production.

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.

The expansion has doubled Cambrex’s footprint to 15,000 ft2, including an added 3500 ft2 of laboratory space.

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

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.