Increases in Manufacturing Capacity Target Vial and Syringe Shortages

With some COVID-19 vaccines being released under Emergency Use Authorization by regulatory bodies, the challenge now is having enough doses to serve the market. Among the supply challenges the industry must contend with is a perception that components such as syringes and vials in which the vaccines will be packaged are in short supply. However, the situation is not so dire, and manufacturers of these components have begun steps to increase manufacturing capacity.

Lawrence Ganti, president and chief business officer of SiO2 Materials Science, notes that there continues to be some issue with supply, although the situation has changed. “Some of the vial and syringe manufacturers have re-prioritized their supply to support the vaccines that have come to market,” he says. However, the next wave of vaccines is being told as having long lead times, upwards of six months, and it will not only be a supply issue. “Some of these new vaccines have challenges with their formulation, which make traditional glass less than ideal,” he says.

A company official for Becton, Dickinson and Company (BD), a global medical technology company, says that, while some product categories are in tight supply, there is not currently a shortage of needles and syringes as an overall category, and no shortage of syringes that are appropriate for vaccinations. “BD has received orders for more than 1 billion injection devices, which include the needles and syringes, across the world to support global COVID-19 vaccination planning efforts,” the official notes. These orders reflect commitments from countries, including the United States, Australia, Belgium, Canada, Germany, the Netherlands, Saudi Arabia, Spain, and the United Kingdom, among several others, as well as non-governmental organizations that are supporting vaccine deployment for developing countries, the official states.

The BD official explains that shipments for these orders are already underway, and more than 400 million injection devices have been delivered around the world to date, with the remaining orders to be delivered between now and the end of 2021 to support vaccine administration. “We also continue to plan supply capabilities to ensure maximum volumes can be dedicated to COVID-19 efforts while minimizing disruption for routine health care and normal vaccination efforts, such as childhood immunizations and flu vaccines,” the official says.

Fabian Stöcker, vice-president global strategy and innovation at SCHOTT Pharmaceutical Systems, has a steadfast view. “The fact that the vast majority of COVID-19 vaccine projects rely on borosilicate glass shows that the material is the best suited option for numerous formulations. We understand that the thought of vaccine distribution being hampered by the availability of glass vials appears alarming, but once you gain a deeper understanding of the supply chain, you will find that the process is well tuned-in,” he states, explaining that a packaging supplier is part of the development of a vaccine from the beginning. Hence, the supplier would know months ahead what container and quantity will be needed for which drug product, giving enough room to prioritize production.

“With regard to COVID-19, the pharma companies told us about their project timelines in early 2020, and we have been (and will be) delivering the required quantities when they need them. This ranges from a few (hundred) thousand vials for the clinical trials, to industry-scale supply in the range of millions later on,” Stöcker says.

He emphasizes that SCHOTT sees the sourcing of COVID-19 vaccine components as a joint task in the industry. The fact that all major glass and packaging providers had made significant investments to expand capacity before the pandemic and considering the timeline of vaccine development, SCHOTT is optimistic that adequate supply with glass vials can be achieved, Stöcker says. “In other words, if the industry pulls together, we are optimistic that the goals can be met,” he notes.

Fran DeGrazio, chief scientific officer of West Pharmaceuticals, also takes an optimistic tone, saying that the industry is responding positively by increasing capacity in vial and syringe—and related components—manufacturing. “Specific to West Pharmaceutical Services, we are fortunate to have an assortment of manufacturing capability across the globe for both elastomers and seals manufacturing. We had plans for further capacity expansion, but the onset of the COVID-19 situation accelerated those plans,” she states. West has also focused on accelerating the startup and utilization of new equipment and capacity to address the increased COVID-19 demand, she adds.

A look at increases

Recent investments in manufacturing capacity include Corning, BD, and SiO2. In June 2020, Corning was awarded $204 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, through its partnership with the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command. Under the contract, Corning was tasked with expanding its domestic manufacturing capacity for its glass vials for COVID-19 vaccines (1).

In July 2020, SiO2 completed the scale up of their manufacturing capacity to 400 million doses and are on track to hit 1.2 billion capacity before the end of 2020 (2) after receiving a $143-million contract from the US government in June (3). BD, meanwhile, announced a $1.2-billion investment in December 2020 over the course of four years to expand and upgrade manufacturing capacity and technology for pre-fillable syringes and advanced drug delivery systems. The project will span across the company’s six global manufacturing locations and includes the addition of a new manufacturing facility in Europe (4).

“Since the start of the COVID-19 pandemic, BD has been working around the clock discussing needs with governments across the world and running needle and syringe production lines 24/7,” the BD official says. The company has also been working to support immediate efforts for COVID-19 vaccinations and is also working on a long-term strategy to ensure global readiness for future pandemic vaccination efforts.

“We are partnering with the US government on a $70-million capital project to further expand our operations and manufacturing capacity in Nebraska. This is expected to be online this summer, and, once completed, the federal government will have priority access to hundreds of millions of injection devices to support vaccination efforts for COVID-19 and future pandemics,” the BD official states.

To a certain extent, recent capacity upgrades will be sufficient, but the supply situation is dependent on how the real market evolves, cautions Ganti. “How many doses and how often? How many vaccines actually make it to market? We tend to forget that there has been so much prioritization towards COVID vaccines, that even with the added supply of vials and syringes, we need to also remember that there are other medications that require the same vials and syringes. Thus, you likely won’t hear much about vial shortages for the vaccines, but we will start to hear about vial shortages for other medications,” he forewarns.

SCHOTT, meanwhile, had set up an investment program in 2019, which enables the company to ramp up production in its global production network quickly, says Stöcker. Stöcker notes that the company’s $1-billion investment program in its pharmaceutical business is in full swing despite the pandemic. “Many new lines are already up and running, and, by the end of 2021, we will have already implemented 50% of these projects,” he states.

“Another thing to remember is that with COVID-19, time is a luxury the world doesn’t have,” Stöcker continues. “It makes sense for pharma companies and authorities to rely on existing infrastructure that can be ramped up quickly, and to use tried-and-true packaging materials such as borosilicate glass vials for two reasons. Firstly, pharma companies know how the glass behaves with regard to specific drug compositions and buffer solutions. Secondly, they have been processing it on their filling lines for a long time, meaning that no adjustments or re-validation by the authorities would be necessary to fill a COVID-19 vaccine,” he adds.

Supply chain vulnerability

Ganti notes that the entire supply chain is constrained. Although raw materials for glass, for instance, are certainly being enhanced, it takes time to bring on glass tubing capacity. Rubber supplies as well are starting to feel a constrain, he says. “The biggest realization is for the smaller guys and second and third wave of vaccines. The big glass manufacturers are asking for large upfront payments and/or lead times upwards of six months. That might be fine for a large corporation, but it is rather difficult for the smaller innovative companies who are trying to bring their vaccine or therapy to market,” he states.

Early planning and preparation are critical, the BD official emphasizes. Planning ahead provides the best opportunity for the global industry to manufacture the number of devices required to be ready for mass vaccination programs, the official explains. As an example, BD was already starting to ramp up production as early as April 2020, primarily for devices to support flu vaccination—because flu vaccine demand typically increases drastically during or after a pandemic. “From that point, BD partnered with governments to learn what specific needs they have and help educate them to place orders as early as possible,” the official notes.

SCHOTT, meanwhile, is in a more secure position, because the company itself produces the pharmaceutical glass tubing for vaccine packaging and is also able to adjust the capacities for glass production in advance. “This also benefits packaging manufacturers who do not have their own glass production facilities,” Stöcker says.

“Of course, there are many aspects that need to come together to meet production requirements,” adds DeGrazio. “When you consider the full supply chain, the storage of many of these vaccines occurs at ultra-low or frozen temperatures. A most significant challenge for these is distribution and storage under the defined conditions to assure vaccine efficacy. There must be enough capacity from a transportation standpoint and for storing the vaccines under the appropriate conditions at the site where they will be given,” she states.

Future needs

As the rollout of different COVID-19 vaccines progresses gradually, the future sourcing situation for vials and syringes remains uncertain and a bit complex.

The different pharma companies’ vaccination programs show great variations, Stöcker points out. He explains that some companies want to package a single dose in a small vial, while others want to package five doses or more in a larger vial. “Consequently, the mere number of glass tonnage or vials doesn’t give too much of an indication of the supply situation. That is why we have decided to talk about vaccine doses rather than packaging units,” he says.

“If you add up the volume of the COVID-19 vaccine projects we are involved in, we are supplying vials for around 2 billion doses of the COVID-19 vaccine. These include projects that you hear about in the media. The delivery will take place in several project phases; this ranges from a few (hundred) thousand vials for the clinical trials, to industry-scale supply in the range of millions later on,” Stöcker adds.

Ganti says that trying to anticipate the number of vials and syringes needed in the future is a fuzzy prediction. Predicting numbers is a balance game, first taking into consideration the needs of pharma companies looking to have multi-dose vials initially and then eventually moving on to more convenient options. “There is also the challenge of making the actual drug product and ensuring distribution to the end patient. We will still require billions of vials and syringes to meet the global demand for the vaccines. Do we have enough? For some, yes. Can we do more? Absolutely,” he says.

BD’s understanding of the sourcing situation, based on the company’s engagement with different governments, is that countries are preparing for a two-shot injection of a COVID vaccine. “There is clearly a lot of variability in the timing of vaccine availability and uptake that impact the planning process. While we can’t comment on the exact number of vials and syringes required, we are in continued discussions with governments and non-governmental organizations to support short and long-term needs that will enable the delivery of vaccinations around the world,” the BD official states.

“As a major supplier to the industry, I can tell you that we are working very closely with all our customers to understand their demands,” adds DeGrazio. “As for dosing per vial and how many vial systems or syringe systems are needed, this is something that each pharmaceutical company must understand based on their specific vaccine and their fill/finish capacity. Based on their needs, they would work with their suppliers to assure that the proper materials are available for use,” she states.

References

1. Corning, “U.S. Departments of Defense, Health & Human Services Select Corning Valor Glass Packaging to Accelerate Delivery of COVID-19 Vaccines,” Press Release, June 9, 2020.
2. SiO2 Materials Science, “SiO2 Scales Manufacturing of Hybrid Vial Capacity for 400 Million Doses of COVID-19 Vaccine Achieved Ahead of Schedule,” Press Release, July 2, 2020.
3. SiO2 Materials Science, “SiO2 Materials Science Receives $143 Million Contract from US Government to Accelerate Capacity Scale-Up of Advanced Primary Packaging Platform for COVID-19 Vaccines and Therapeutics,” Press Release, June 8, 2020.
4. Becton, Dickinson and Company, “BD to Invest $1.2 Billion in Pre-Fillable Syringe Manufacturing Capacity Over Next Four Years,” Press Release, Dec. 2, 2020.

About the author

Feliza Mirasol is the science editor for BioPharm International.

Article Details

BioPharm International
Vol. 34, No. 3
March 2021
Pages: 40–43

Citation

When referring to this article, please cite it as F. Mirasol, “Increases in Manufacturing Capacity Target Vial and Syringe Shortages,” BioPharm International 34 (3) 2021.