SiO2’s Smart Vials and Operation Warp Speed: The Development of a New Hybrid Packaging Solution for COVID-19 Vaccines

As the COVID-19 pandemic stretches over the second wave, over 50 million cases and 1.25 million deaths worldwide have been recorded. The global hunt for a vaccine is more important now than ever before, and scientists are researching at a breakneck pace. Through Operation Warp Speed (OWS), the federal government has accelerated the efforts of researchers and organizations to develop and distribute vaccines that are effective and safe. The Food and Drug Administration (FDA) has provided guidance for fast-tracking vaccine development and market approval of a COVID-19 vaccine. So far, OWS has funded Phase III trials for three vaccines: Moderna’s mRNA-1273, University of Oxford and AstraZeneca’s AZD1222, and Pfizer and BioNTech’s BNT162.2 OWS is also partnering with more than 18 biopharmaceutical companies as they race to develop more vaccine candidates.

A Global Shortage of Traditional Vaccine Vials

The critical need to develop a safe and effective vaccine is just the first step. While Pharma is highly focused on vaccine development, companies also recognize that there’s a need for a sufficient supply of optimal packaging options to fill, store, and distribute billions of vaccine doses worldwide. In other words, we need enough vials to put the vaccine in, and we don’t have enough to go around. For more than 100 years, pharma companies have used borosilicate glass in the manufacture of vaccine vials. Schott AG, one of the largest producers of this vaccine-grade glass, controls much of the market. But executives from Schott AG have admitted to The Wall Street Journal that they have received requests for a billion vials, and this is double what they can manufacture in 2020. Moreover, borosilicate glass is facing a global shortage due to its unprecedented demand. Complications during production can also delay or shut down the manufacturing process. Glass vials can break due to glass-to-glass contact, and they don’t always break cleanly. The small broken particles can contaminate the vaccines. Contamination can also occur when glass delaminates from the inner walls of the container after prolonged exposure to some drug formulations. Furthermore, particles can interact with the active pharmaceutical ingredients in the drug formulation, which can reduce drug potency and form aggregates that are immunogenic to the patient. With so many vials in production, even a small percentage of defects can lead to severe consequences. The problems of unprecedented demand, breakage, and delamination of borosilicate glass are further confounded by questionable sealing integrity at cold storage temperatures. Plastics have naturally received a surge of attention but have drawbacks that can compromise drug efficacy and stability. Although plastics outperform glass in terms of toughness and resistance to breakage, they are permeable to gas and water vapor, which means that the pharmaceutical active ingredients, excipients, or solvents in vaccines can interact with them easily. To avoid a scenario where a company manufactures a safe and effective vaccine and does not have a sufficient supply of packaging materials, we need a strong alternative for borosilicate glass or plastic primary packaging.

A New Hybrid Packaging Solution

SiO2 Materials Science (SiO2) has spent the past 10 years developing a new hybrid packaging solution that is more effective than previous packaging materials. Championed by the Operation Warp Speed Initiative, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded SiO2 a $143 million grant to accelerate the production of vials and secure a domestic supply for the COVID-19 vaccine. This partnership has increased our scope by an exponential margin. Before the coronavirus outbreak, SiO2 could manufacture 14 million 10 mL vials per year. The BARDA contract has expanded our capacity to 40 million in June, 80 million in September, and 120 million in November.

Interlinking the Benefits of Glass and Plastic

Si02’s innovative primary packaging – in the form of 10 mL vials and pre-filled syringes – combine the benefits of glass and plastic without their respective drawbacks. According to Christopher Weikart, chief scientist at SiO2, “We’re basically taking the best of glass and plastic and combining the benefits of both into a hybrid material.” How have we accomplished this? Si02 scientists chose a medical-grade, engineered cyclic olefin polymer, a type of plastic, as the base for the hybrid packaging material. Then they eliminated the characteristics of plastic that causes it to interact with the proteins found in a vaccine by engineering a chemically inert coating process. The process technology used to deposit the coatingremoves the air from the inside of plastic containers and fills the space with a special mixture of gases that contain the basic building block of silicon dioxide glass (SiO2) . The process applies an electromagnetic field across the container at very low pressure, activating the SiO2 gas and creating a layer of pure glass-like silica. The final product does not dissolve or interact with the compounds in a vaccine. SiO2 is not a combination of glass and plastic; it’s more than that. The layer of pure glass-like silica mimics glass by offering the oxygen and moisture barrier properties of glass without the risks of breakage and delamination. For example, the oxygen barrier performance of the coating is retained even after 1000 lbs. of compression force is applied to the coating. Another benefit of our hybrid packaging material is that it has the optical clarity and appearance of glass, but is about half the weight. Lastly, the glass-like silica coating is chemically inert and resistant to a wide range of pH values and excipients. Results of comprehensive extractables and leachables (E&L) testing on SiO2 vials revealed that the drug contact surface was ultra-clean without any compounds originating from the underlying polymer. Any detectable compounds were at trace levels or well below the established analytical evaluation thresholds.

Why Si02 is the Future of Primary Containers

Long-established glass manufacturers typically require up to 18 months to scale their manufacturing operations. But at SiO2, it only takes four months. This means that pharma companies can increase the bandwidth for making more COVID-19 vaccines and, hence, save more lives. This also implies that Si02 is first-to-market with an innovative product that is more effective than its predecessor. So far, SiO2 has shipped its hybrid vials to five vaccine manufacturers. Although sponsored by BARDA, SiO2 has the liberty to support both BARDA-funded and non-BARDA-funded pharma companies. As many wait for a COVID-19 vaccine, we hope that SiO2 can be instrumental and play a significant role in the quest to prevent the spread and fatality of the SARS-CoV-2 virus that causes COVID-19.
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References
  1. CDC. Frequently Asked Questions about Vaccination. Centers for Disease Control and Prevention. Published February 11, 2020. Accessed November 8, 2020. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html
  2. COVID-19 vaccine tracker. Accessed November 8, 2020. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
  3. Hinshaw JSH and D. Coronavirus Vaccine Makers Are Hunting for Vital Equipment: Glass Vials. Wall Street Journal. https://www.wsj.com/articles/coronavirus-vaccine-makers-are-hunting-for-vital-equipment-glass-vials-11592317525. Published June 16, 2020. Accessed November 8, 2020.
  4. Coronavirus vaccine: Inside US $347m contracts to solve vial shortages – Business Insider. Accessed November 10, 2020. https://www.businessinsider.com/coronavirus-vaccine-glass-shortage-operation-warp-speed-corning-sio2-2020-6
  5. Weikart CM, Breeland AP, Wills MS, Baltazar-Lopez ME. Hybrid Blood Collection Tubes: Combining the Best Attributes of Glass and Plastic for Safety and Shelf life. Slas Technol. 2020;25(5):484-493. doi:10.1177/2472630320915842
  6. Weikart CM, Pantano CG, Shallenberger JR. Performance Stability of Silicone Oxide–Coated Plastic Parenteral Vials. PDA J Pharm Sci Technol. 2017;71(4):317-327.
  7. Weikart C, Saaler-Reinhardt S. Glass Like Inner Barrier Coating Prevents Contamination of Drug Products with Potential Impurities From Primary Containers Composed of COP, A Case Study. Published online 2016.

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