Manufacturing

The vaccine will be developed using Gritstone’s proprietary prime-boost vaccine platform, which includes self-amplifying mRNA and adenoviral vectors, with antigens formulated by Gilead.

Cytiva acquired Vanrx Pharmasystems, a Canadian manufacturer of robotic aseptic filling equipment.

A contract from the US government will help fund domestic US production of small-molecule APIs and finished dosage forms and will be the first GMP facility using ICM technology.

The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.

The vaccine met the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a South African Phase IIb trial.

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.

Sanofi will offer access to its infrastructure and expertise to help BioNTech produce over 125 million doses of its COVID-19 vaccine in Europe.

Emergent will use its CDMO services to manufacture drug product batches to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021.

Clinical material for a Theratechnologies product in development will be produced at PPS’ manufacturing facility in Lexington, KY.

The site, which is set to be operational in three years, will feature disposable technology and advanced technology filling lines to produce 90 million vials and 50 million pre-filled syringes a year.

The two facilities consist of 260 and 130 permanent staff members respectively and produce liquid-filled hard capsules and softgels for the pharmaceutical market as well as other markets.

The companies have entered into an advance purchase agreement with COVAX to provide up to 40 million doses of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to lower-middle-income countries.

The company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, to focus on advancing its two SARS-CoV-2/COVID-19 therapeutic candidates, MK-4482 and MK-7110.

The new US offices will give the company the ability to support its US-based customers on site while continuing to collaborate with its global team.

Henogen will be integrated into Thermo Fisher’s Pharma Services business within its Laboratory Products and Services segment.

The 40,000-ft.2 facility will feature eight cleanrooms with configurations for the production of cell and viral vector products.

The acquisition significantly expands Precision Medicine Group’s cell and gene therapy expertise.

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.

The 17,000 m2 facility will serve as a process development and manufacturing site for Chinese companies developing medicines as well as multinationals with manufacturing requirements in China.

Packaging and transporting large quantities of COVID-19 vaccines pose challenges for the cold chain.

Acorda’s Chelsea, MA facility will serve as a global center of excellence in the Catalent network for spray-dried dispersion and dry powder encapsulation and packaging.

Baxter will provide commercial-scale manufacturing services at its Halle/Westfalen, Germany facility to prepare Novavax’s COVID-19 vaccine candidate for distribution in the United Kingdom and European markets.

The company plans to expand its global production capacity across six existing manufacturing facilities in Europe and the United States, as well as a new manufacturing facility in the US.

The new facility, which will be operated by Fujifilm Diosynth Biotechnologies, will provide large-scale cell-culture manufacturing of bulk drug substance with 8 x 20,000-L bioreactors.

The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement.

Bayer will support the development and supply of CureVac’s COVID-19 vaccine candidate, CVnCoV.

The transaction will include operations located at different Novasep sites, including its Pompey, France site and sites in the United States, China, and India.

The new facility, to be located in Boston, MA, will contain experimental and analytical equipment for viral vector and advanced therapy process development and will expand the CDMO’s manufacturing capacity.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

Pharmaceutical Technology interviewed Cloudleaf about trends in tracking vaccines through the supply chain.