Answering the hard questions about pharmaceutical packaging supply

Glass vials as packaging for a potential COVID-19 vaccine. Image credits: getty images / onuroner

When it comes to the world’s response to COVID-19, two questions have been at the center of a boiling debate.

How many do we need? How much is good enough?

In recent months, governments, industry, and the general public have asked these questions about a laundry list of materials and directives: personal protective equipment, testing, ICU capacity, and even the stay-at-home measures that much of the world finds itself under.

Recently, pharmaceutical packaging – like vials and syringes – has joined this list. It makes sense to be concerned. When the pharmaceutical industry discovers a sought-after vaccine, will there be enough packaging to get it to the people that need it?

As a packaging manufacturer, the last thing we want is to learn too late that packaging is the weak link in the global supply chain. So, we are sharing what we know and don’t know about the supply situation, so that we, and the industry, can make informed decisions.

Pharmaceutical packaging is a topic few people ever think about. A vial or syringe usually costs just a few cents. The vaccine, on the other hand, could cost tens or hundreds of dollars. Yet packaging is an integral part of the drug product.

First, what kind of packaging would be needed?

Usually, any drug would undergo long-term testing to inform packaging decisions. Over time, any pharmaceutical product will interact with the packaging material. In rare cases, this can harm the efficacy of the drug or lead to side effects. At worst, it might harm peoples’ lives. That’s why regulators have only approved of specific types of pharmaceutical-grade glass or polymers. As a supplier of both materials, we know that each has its pros and cons. The best choice always depends on the specific application.

In terms of COVID-19, however, time is a luxury we don’t have. From this, it makes good sense to choose a material whose chemical properties are well known: Borosilicate glass. This specialty glass has been used for packaging drugs for over 100 years. More than 50 billion containers are made of it per annum. Every single day, more than 135 million injections are administered out of a borosilicate glass container.

That brings us to a second question:

How much additional glass and packaging would be needed to combat SARS-CoV-2?

Based on input from research institutes, World Health Organization pandemic emergency plans, and feedback from our customers in the pharmaceutical industry, we estimate that one billion units are required for an initial global vaccination campaign. That equals roughly 2 percent of the current annual demand for borosilicate glass containers for injectable drugs. Yet, further vials will probably be required for COVID-19 treatments, as well as other unrelated therapies that have been postponed because of the crisis.

The demand for borosilicate glass has indeed exceeded supply in the recent past. The upside: What needs to be done now is a subset of what the industry has been working on anyways. Long before we first heard of COVID-19, all major pharma glass suppliers began building new capacity. SCHOTT alone is increasing its manufacturing of borosilicate glass tubing by 40,000 tons – providing enough raw material to produce an extra 6.8 billion standard vials. Such vials will be the preferred type of packaging for the initial release of the vaccine. Prefilled syringes could be an option, yet contain more parts and substances like a plunger, lubricant, or needle glue, and thus require more testing to reduce the risk of drug/container interaction.

Packaging production is a two-step process. Once the glass tubes have been produced, they are shipped to converters, who re-heat the glass to form the actual container for the drug.

The availability of pharma glass is of lesser concern in the medium run; yet how much idle capacity do the converting companies have to produce the vial or pre-fillable syringe?

That is a tricky question. Additional converting machines don’t fall from the sky, and many moving parts of a complex supply chain have to work seamlessly to make this happen. Yet again: The converting companies, too, have been working on increasing capacities, with build-in options for even further growth. In SCHOTT’s case, the combined investment in Borosilicate glass production and converting sums up to US$ 1 billion, equaling half of our annual turnover. We can confirm that our projects are on track. Besides, ready-to-use vials designed for vaccine candidates in clinical trials are readily available from our plant in Pennsylvania, USA.

The one remaining question then would concern the established production and filling capacity for COVID-19 vaccinations. Here, many of the already involved pharma companies signal sufficient capacities for global vaccination campaigns.

In a post-coronavirus world, many things will be fundamentally different. In terms of pharmaceutical packaging, however, it’s more about connecting the dots and making wise use of what is already there. As an industry, we need to focus on ramping up our previously planned capacities. We also need to keep up the knowledge exchange and work together on setting the right priorities. It will certainly be a stretch. But at least, the industry has set the right course.

June 18th, 2020

Kontakt

Björn Weller
Pharmaceutical Packaging
SCHOTT AG

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