By Christopher Weikart, Chief Scientist at SiO2 Materials Science
Why is an incredibly innovative and forward-thinking industry like pharmaceuticals being held back by the products that haven’t changed in over a century?
The glass used to package, store, and deliver drugs today was created in 1881 — just 16 years after the Civil War ended — and has changed very little since then, and it’s these vials that drug companies, who are creating ever-evolving, more complex drugs, are beholden to use. Breakage, surface interactions with drugs, shedding, and other glass issues can cause contamination, particulate matter in the drug, recalls, and injury if administered. Yet drug companies don’t have alternatives but to use legacy glass.
Isn’t it time that changed? In order to save lives, treat illness, and even vaccinate against a global pandemic, the next generation of drugs needs better alternatives for packaging. Here’s why, and what we need for the future.
The History of Borosilicate Glass
The production of glass has been around for thousands of years, and by the late 19th century, the glass produced at the time (and still today) was called soda lime glass, made from a blend of silicone oxide, sodium carbonate, and calcium oxide. Soda lime glass was used for everything, from windows to beer bottles, but this type of glass was ineffective in industrial and laboratory settings. It just couldn’t stand the sudden changes in temperature, which resulted in extreme thermal expansion and shattering.
In the 1880s, German glassmaker Otto Schott began to experiment with making glass more temperature resistant, and added boron to the mix, thus making the glass more resilient to temperature changes and thermal shock. Borosilicate glass was born. The everyday consumer probably has this type of glass in their kitchen in the form of Pyrex cookware, and Schott, the company Otto founded, has been producing glass products for many industries, including vials and syringes for drug delivery.
But since the time of its discovery, borosilicate glass has changed very little — and that’s a problem when the industry that uses these glass vials and syringes has changed a lot.
Packaging Biologics
Up until about 30 years ago, the pharmaceutical industry was mainly creating small molecule drugs, and for small molecule drug delivery, borosilicate glass was a viable option. Yet evolving technology allowed drug companies to begin creating biological drugs, or biologics, derived from living organisms as opposed to small molecule drugs synthesized in a laboratory. This has allowed for incredible advances in the ability to treat disease, and as of 2020, seven of the ten best-selling drugs were biologics. Today, 70% of new drugs in development are biologics.
But while biologics are the future of drug manufacturing, they are incredibly complex drugs, which are sensitive to the environment they’re in, like the temperature they’re stored in, their resistance to chemical exposure, or any physical force exerted upon them. Those following the news during the COVID vaccine development heard about the concerns of having to store Pfizer’s vaccine at such low temperatures. This means that biologics need a robust, temperature-resistant, unbreakable, resilient container they can not only be transported in but administered through as well.
The Problems with Glass
However, glass has a lot of issues when it comes to being an effective container for today’s drugs.
The surface of glass has chemical properties that can negatively interact with the drugs it holds, causing contamination. Glass can also shed into the drug, causing particulate matter to appear that could injury or kill someone, if administered (one FDA glass-based recall announcement says administered particles “could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences”).
Glass also breaks easily, causing manufacturing to shut down, or introduction of glass particles into drugs, or even injury (as was the case in a March 2020 recall of a drug due to “ampules breaking and shattering, upon opening, during compounding,” and reports of “cuts in skin and lacerations to health care professionals”).
Glass is also hard to mold and coat to create new devices for administering the drug it carries. And with a lack of alternative materials for vial and device production, drug companies are left with packaging that can contaminate their drugs and endanger their patients.
What We Learned from COVID
As the COVID-19 pandemic raged, drug makers devoted time, energy, and resources to getting a vaccine out to the world — only to see that their efforts might have been derailed by a lack of glass vials. The number of glass vials needed for getting vaccine doses to everyone on the planet wasn’t yet created, and production of the needed supply was expected to take years. Sand supply to make borosilicate glass was in high demand as well, and only a few glass manufacturers essentially controlled the supply of glass vials.
But at the root of the bottleneck was one thing: The industry is too reliant on glass.
Does borosilicate glass, and the industry’s dependence on it, sound like it could stand up to the requirements of what today’s — and tomorrow’s — drugs need in order to be delivered and administered safely and effectively? The answer is no, which is why the industry needs something new.
Next-Gen Drugs Need Next-Gen Packaging
Borosilicate glass served its purpose for a time. But it’s a faulty material that can no longer keep up with the complexities needed for drugs today, in terms of reducing chemical interactions, withstanding breakage, and keeping the particulate matter out of solutions. Too much reliance on borosilicate glass and the handful of companies producing it means not enough diversification in the industry as well. No patient should be deprived of life-saving medications because the packaging didn’t hold up.
