Next Generation Vials for COVID-19 Vaccines and Cell and Gene Therapies
The emergence of cell and gene therapies and new COVID-19 vaccines brings the promise of treating some of the most challenging diseases. Storage, transport, and delivery of these breakthrough therapies for safe clinical use has its own set of challenges. These new therapies and vaccines are complex and inherently unstable, requiring storage at extremely cold temperatures or lyophilization to preserve the formulation. SiO2 Materials Science (SiO2) has developed primary containers that are ideally suited for sensitive therapeutics and vaccines. We are turning the corner, away from traditional glass vials for COVID-19 vaccines and cell and gene therapies. The containers are made of a hybrid material that combines the best attributes of glass and plastic without any of the drawbacks. SiO2 vials enable the following combined features including ready-to-use, track-and-traceable, particle free, leachable free, no breakage and container closure integrity (CCI). SiO2 vials can withstand exposure to temperatures approaching liquid nitrogen (-196°C) without breaking. Moreover, SiO2 vials support larger fill volumes after drug product lyophilization without breakage. Maintaining seal integrity at cryogenic temperatures is arguably one of the more challenging features to ensure and many traditional test methods are not well suited to detect failures. A cold storage aging study was conducted using a novel CO2 headspace test method to illustrate the seal integrity of SiO2 vials. A lyo study at various fill volumes with a mannitol formulation was conducted to illustrate breakage resistance. These studies will be presented along with customer evaluations of SiO2 vials filled with a viral vector formulation and subjected to cold storage at -80°C.
- Seal Integrity (CCI) at cryogenic temperatures
- Lyophilized drugs at 100% fill volumes without breakage
- Proven technology used for COVID-19 vaccines and biopharmaceutical therapies
Christopher Weikart, Ph.D. is Chief Scientist at SiO2 Materials Science. Dr. Weikart is responsible for managing both internal and external R&D initiatives, including collaborative studies at domestic and international universities, customers and research organizations. He has oversight for the company’s innovation strategy and the development of new technologies to address customer-centric problems. Dr. Weikart works closely with SiO2’s Scientific Advisory Board and technical consultants for launching new technical initiatives. He also works closely with the intellectual property department to provide technical support for patent filings and trade secret preservation. He is the technical ambassador and spokesman at conferences, customers, and regulatory bodies. Dr. Weikart earned a PhD in chemical engineering from the University of Missouri-Columbia. He worked in Central Research at the Dow Chemical Company for 12 years in various R&D, engineering and leadership roles. Dr. Weikart earned a 6 Sigma Black Belt.