COVID News: EU, Samsung Biologics & More

The latest on COVID-19 vaccines/drugs and manufacturing featuring the Samsung Biologics, GreenLight Biosciences, HIPRA Human Health, and European Commission. Highlights below.

Manufacturing and supply of COVID-19 vaccines and drugs
EU Signs Procurement Contract for HIPRA’s COVID-19 Vaccine
* Samsung Biologics, Greenlight Biosciences Complete COVID-19 Vaccine Engineering Run

Manufacturing and supply of COVID-19 vaccines and drugs

EU Signs Procurement Contract for HIPRA’s COVID-19 Vaccine
The European Commission’s Health Preparedness and Response Authority has signed a joint procurement framework contract with HIPRA Human Health, an Amer, Girona, Spain-based bio/pharmaceutical company, to allow 14 European Union (EU) member states and countries participating in the EU’s joint procurement framework to purchase up to 250 million doses of HIPRA’s COVID-19 vaccine.

HIPRA’s vaccine is under rolling review by the European Medicines Agency. It is a bivalent recombinant protein booster dose being evaluated in previously immunized persons 16 years of age and older.

The EU’s Joint Procurement Agreement allows 36 participating countries to jointly procure medical countermeasures as an alternative or complement to procurement at national levels. The joint procurement contract with HIPRA complements a portfolio of approximately 4.2 billion doses of COVID-19 vaccines secured through the EU Vaccines Strategy, including contracts signed with AstraZeneca, Sanofi–GlaxoSmithKline, Johnson & Johnson’s Janssen Pharmaceutica, Pfizer–BioNtech, Moderna, Novavax, a Gaithersburg, Maryland-based vaccine company, and Valneva, a Saint-Herblain, France-based vaccine company.

Source: European Commission

Samsung Biologics, Greenlight Biosciences Complete COVID-19 Vaccine Engineering Run
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, and GreenLight Biosciences, a Medford, Massachusetts-based biotechnology company of ribonucleic acid (RNA) products, have completed the first commercial-scale engineering run for GreenLight’s mRNA COVID-19 vaccine.

The companies formed a partnership in December 2021 under which Samsung Biologics would  manufacture GreenLight’s mRNA COVID-19 vaccine candidate at commercial scale, and the companies have since completed technology transfer and scale-up. GreenLight’s process involves drug substance and lipid nanoparticle formulation to bulk drug product. Earlier this year (2021), Samsung Biologics completed an expansion of its mRNA drug-substance manufacturing suite at its site in Songdo, South Korea, where the company provides end-to-end mRNA production of both the drug substance and drug product (aseptic fill–finish).

With the demonstration at Samsung, and with GreenLight’s COVID-19 booster vaccine clinical trial expected to start in 2022, GreenLight would be capable of supplying mRNA vaccine at a commercial scale. A second engineering run will start this month (August 2022) to implement improvements indicated by the first run and to demonstrate repeatability at scale​.

Separately, GreenLight Biosciences announced late last month (July 2022), a collaboration with the US National Institutes of Health (NIH) to develop COVID-19 vaccines that are more broadly protective against new variants and with longer-lasting effects. GreenLight—in collaboration with the Vaccine Research Center, part of NIH’s National Institute of Allergy and Infectious Diseases—will co-design and test mRNA vaccines against coronaviruses with the goal of developing vaccines that confer a more durable immune response than current vaccines. In addition, they will work together to develop systems that expedite new designs into clinical use.

Source: Greenlight Biosciences (NIH collaboration) and GreenLight Biosciences (Samsung Biologics)