APR September/October 2020 - 61
VENDOR VIEWPOINT
There is growing concern that glass manufacturers cannot meet the
surge in demand for the launch of a COVID-19 vaccine.21,22 This is
compounded with the existing and growing demand of the biologics
market. The ability to rapidly ramp up production capacity is essential
to meet the short-term Operation Warp Speed goal of 300 million
doses by January of 2021 and hundreds of million more after that. We
believe that SiO2 technology has a clear advantage over traditional
glass manufacturing in rapidly scaling up production capacity. This is
enabled by state-of-the-art molding equipment for the cyclic olefin
polymer vial and plasma coating modules that can add capacity as
simple as plugging in additional USB devices to a laptop. Over 80
million vial units of annual vial capacity is already in place at SIO2 in
Auburn, Alabama with another 50 million units expected to come
on-line by December 1st. It takes approximately 3-4 months to add
additional capacity.
Figure 4. Particle counts measured by light
obscuration across 6 different lots of 6 mL SiO2 vials.
The USP 789 limits for particle >10 and >25 micron in
size are shown.
Primary Container Selection for COVID-19 Vaccines
The current pandemic has the world preparing for the safe delivery of
a COVID-19 vaccine. Uncertainty about the performance of ordinary
glass under cold storage, the ability to scale up quickly, supply chain
issues and fill-finish compatibility has vaccine developers and the US
government considering better packaging options. We believe SiO2 is
well-positioned to supply high quality products to regulated markets
at very high volume. If compromise is not an option for new COVID-19
vaccines to manage risk, we believe SiO2 primary packaging provides
the best possible solution.
References
1.
Jiang, G.; Akers, M.; Jain, M.; et. al., Mechanistic studies of glass vial breakage for frozen
formulations. II. Vial breakage caused by amorphous protein formulations. PDA J Pharm
Sci Technol 2007, 61 (6), 452-460
2.
Chow, E. J.; Kitaguchi, B.; Trier, M., Effects of Subzero Temperature Exposure and
Supercooling on Glass Vial Breakage: Risk Management and Other Applications in Cold
Chain Distribution. PDA J Pharm Sci Technol. 2012, 66 (1), 55-62.
3.
Nieto, A.; Roehl, H.; Adler, M.; Mohl S., Evaluation of Container Closure System Integrity
for Storage of Frozen Drug Products: Impact of Capping Force and Transportation. PDA J
Pharm Sci Technol 2018, 72 (6), 544-552.
4.
Zuleger, B.; Werner, U.; Kort, A.; Glowienka, R.; Wehnes, E.; Duncan, D., Container/Closure
Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for LowTemperature Storage at -80 °C. PDA J Pharm Sci Technol 2012, 66 (5), 453-465.
5.
Sacha, G. A.; Saffell-Clemmer, W.; Abram, K.; Akers, M. J., Practical Fundamentals of Glass,
Rubber, and Plastic Sterile Packaging Systems, Pharm Dev Technol 2010, 15 (1), 6 -34.
6.
Nakamura, K.; Abe, Y.; Kiminami, H.; Yamashita, A.; Iwasaki, K.; Suzuki, S.; Yoshino, K.;
Dierick, W.; Constable, K. A, Strategy for the Prevention of Protein Oxidation by Drug
Product in Polymer-based Syringes, PDA J Pharm Sci Technol 2015, 69 (1), 88 -95.
7.
Hamedani, Y.; Macha, P.; Bunning, T. J.; Naik, R. R.; Vasudev, M. C., Plasma-Enhanced
Chemical Vapor Deposition: Where we are and the Outlook for the Future. Chemical Vapor
Deposition - Recent Advances and Applications in Optical, Solar Cells and Solid State
Devices, 2016, 247-280.
8.
Jones, S. W., Introduction to Integrated Circuit Technology. IC Knowledge LLC (2005).
9.
Weikart, C. M.; Pantano, C. G.; Shallenberger, J. R., Performance Stability of Silicone
Oxide-Coated Plastic Parenteral Vials. PDA J Pharm Sci Technol 2017, 71, 317-327.
10.
USP <660> Containers-Glass
11.
USP <1660> Evaluation of the Inner Surface Durability of Glass Containers
12.
Weikart, C. M.; 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. Extractables & Leachables Europe, Dublin, 2016.
13.
Weikart, C.M.; Breeland, A. P.; Wills, M. S.; Baltazar-Lopez, M., Hybrid Blood Collection
Tubes: Combining the Best Attributes of Glass and Plastic for Safety and Shelf-life, SLAS
Technology, 2020, 25(5), 484-493.
14.
Vieregg, J. R.; Martin, S. J.; Breeland, A. P.; Weikart, C. M.; Tirrell, M. V., Inhibiting
Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic
Parenteral Vials. PDA J Pharm Sci Technol 2018, 72, 35-43.
15.
Fabre, A. L.; Colotte, M.; Luis, A.; Tuffet, S.; Bonnet J., An Efficient Method for Long-term
Room Temperature Storage of RNA. Eur J Hum Genet, 2014 Mar, 22(3), 379-85.
16.
Seelenfreund, E.; Robinson, W. A.; Amato, C. M.; Tan, A. C.; Kim, J.; Robinson, S. E., Long
term Storage of Dry Versus Frozen RNA for Next Generation Molecular Studies. PLoS One.
2014, 9(11), e111827.
17.
Zhang, C.; Maruggi, G.; Shan, H.; Li, J., Advances in mRNA Vaccines for Infectious Diseases.
Front Immunol, 2019, 10, 594.
18.
Hunt, C. J., Technical Considerations in the Freezing, Low-Temperature Storage and
Thawing of Stem Cells for Cellular Therapies. Transfus Med Hemother, 2019 Jun, 46(3),
134-150.
19.
Weng, L.; Beauchesne, P. R., Dimethyl Sulfoxide-free Cryopreservation for Cell Therapy: A
Review. Cryobiology. 2020 Jun, 94, 9-17. doi: 10.1016/j.cryobiol.2020.03.012. Epub 2020
Apr 2. PMID: 32247742.
20.
Krenz, H., Beyond Glass: Next Generation of Pharmaceutical Packaging, Pharmapack
Conference, Paris, 2016 Feb.
21.
Rowland, C. A., Race is on to Make Enough Small Glass Vials to Deliver Coronavirus Vaccine
Around the World, The Washington Post, 2020 Jul.
22.
Bostock, B., Inside the US Government's $347 Million Plan to Fight the Global Glass Vial
Shortage Ahead of a Coronavirus Vaccine Rollout, Business Insider, 2020 Jun.
61
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