MATERIAL DEVELOPMENTS

Combining the Benefi ts of Glass and Plastic for the COVID-19 Effort SiO2 Materials Science receives a $143 million contract from the U.S. government.

KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT

Operation Warp Speed (OWS) is a partnership among components of the Department of Health and Human Services (HHS), including the CDC, FDA, NIH, the DoD, and the Biomedical Advanced Research and Development Authority (BARDA).

As of press time, the OWS eff ort aims to deliver 300 million doses of a safe, eff ective vaccine for COVID-19 by January 2021—part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures) which will require a signifi cant number of vials and other packaging components.

SiO2 Materials Science, a U.S. materials science corporation with novel technology for packaging biological pharmaceuticals and vaccines, recently announced a $143 million agreement with BARDA to accelerate the scale-up of the company’s vial technology.

The primary packaging system combines a plastic container with a microscopic pure silica (glass) coating, undetectable to the naked eye. The patented multi-layer system measures under 0.5 micron thick and includes: • Primary container • Adhesion layer to adhere the coating to the plastic • Silica coating • pH protective layer of silica mixed with carbon

“The nation can produce all the vaccines we want, but we must have appropriate containers to store them and deliver them to patients safely,” explained Dr. Robert S. Langer, institute professor at MIT and advisor to SiO2.

The company reports that its coated materials feature a thermal stability range of -196˚C to 121˚C, with a seal integrity down to -80˚C to accommodate a number of storage conditions. Chemical stability makes the system suitable for a wide range of drug characterizations, including pH ranges from 3-14.

The system is resistant to breakage, withstanding 1,500 pounds of direct force, with the potential to save time, money, and resources in eliminating breakage on the line and post-fi ll. With a gas barrier, the vials have gas permeation properties like glass to provide the shelf life and stability required by many therapies.

SiO2 currently employs more than 200 engineers, scientists, and technicians, most of whom live in Lee County, AL. The company expects to hire 200 more.

↑ Automated transfer station of SiO2 product into the coating machine.

Additional Vaccine Vial News

+ BARDA is partnering with and providing $204 million to Corning to expand domestic manufacturing capacity to produce an additional 164 million Valor Glass vials each year if needed.

Corning will accelerate the scale up of Valor Glass tubing and vial manufacturing at the company’s facilities in NC, NY, and NJ. + The CEOs of Gerresheimer, Stevanato Group, and SCHOTT recently made a statement that they are committed to ensuring ample supply of pharmaceutical containers for any COVID-19 vaccine and treatment that is developed, and that no patient shall be left behind, no matter what region of the world they live in. + The DoD and HHS announced a $138 million contract with

ApiJect for more than 100 million prefi lled syringes for distribution across the U.S. by year-end 2020, as well as the development of manufacturing capacity for the ultimate production goal of over 500 million prefi lled syringes in 2021.