Globally, drug makers are involved in the process of developing a coronavirus vaccine to end the pandemic. But, several have also expressed concerns about a potential shortage of ancillary supplies once the vaccine is developed.
For instance, drug makers need to assure the availability of active pharmaceutical ingredients, along with ancillary supplies namely glass vials, rubber stopper, aluminium seal etc. to launch and distribute a vaccine. Over time, any pharma product will interact with the packaging material. In some cases, this can harm the efficacy of the product or lead to side effects, therefore assuring the quality of packaging materials are paramount.
In the case of a vaccine, glass is considered the best choice of packaging material. According to a statement issued by SCHOTT AG, “In the context of COVID-19, it makes good sense to choose a material whose chemical properties are well known, like borosilicate glass. This speciality 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.”
The statement also highlighted, “Based on inputs from research institutes, the World Health Organization (WHO) pandemic emergency plans and feedback from our customers in the pharma industry, we estimate that one billion units are required for an initial global vaccination campaign. That equals roughly two per cent of the current annual demand for borosilicate glass containers for injectable drugs. Yet, further vials will probably be required for the COVID-19 treatments as well as other unrelated therapies that have been postponed because of the crisis. The demand for borosilicate glass has indeed increased.”
So, is there a shortage?
After understanding the global situation and drug makers’ rush to ensure the ancillary supplies, it sort of created a panic situation not only in the global pharma market but also among Indian drug manufacturers. However, the situation in India seems to be well prepared to deal with the rising demand as the ancillary manufacturers have considerable capacity and capabilities to meet the requirements.
However, Indian ancillary manufacturers assure that they are gearing up to meet the requirements of the pharma industry.
Rishad Dadachanji, Director, SCHOTT KAISHA, replied, “We at SCHOTT KAISHA has enough capacity to cope with the requirements of our customers. Being connected with almost all vaccine suppliers, we are in a comfortable position to deliver. As we know, many companies in India are working towards a successful vaccine. Whoever is out with it first, and desires to source their vials from us, we are more than capable to supply to them. SCHOTT KAISHA manufacturers over three billion pieces of ampoules/vials/syringes and cartridges annually from its plants in Daman, and Jambusar and Umarsadi (Gujarat). Our upcoming facility at Baddi will further add to these numbers.”
Alagu Subramaniam, Managing Director, West Pharmaceutical Packaging India, said, “As a leading solution provider of drug manufacturers and delivery systems, West and our partner, Daikyo are supporting our customers with the COVID-19 opportunities. We have already received the bulk order from many vaccine companies, who are in the advanced stage of clinical trials of COVID-19 vaccine. The companies are placing orders for FluroTec laminated rubber stoppers.”
How is the industry gearing up to meet the demand?
SCHOTT AG 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. Pre-filled 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.
Subramaniam commented, “There are multiple manufacturers like J&J, AstraZeneca (Oxford), GSK/Sanofi etc., involved in the making of COVID-19 vaccine; so, without them coordinating, we might have over one billion doses produced in 2021. In the short term, our FluroTec laminated supplies might see some constraints but it is not an issue to supply such volumes in 2021 and beyond. The company is continuously investing in expanding its manufacturing facility capacities all across the world; for instance, in France, Singapore, the US, Germany, Japan and India. ”
SCHOTT KAISHA has already invested around 50 million euros in the last year and the current year to further expand its facilities. It also has a joint venture with one of the largest manufacturers for tubular glass and containers, SCHOTT AG.
Dadachanji claimed, “Our company is the leading manufacturer of ampoules and vials in India. With four plants all over India (Daman, Jambusar, Umarsadi, Baddi), we will be capable to supply our glass- packaging products and meet the rising demand. I would say we are in a good position to meet our customers’ requirements. SCHOTT KAISHA has been known to scale up extremely fast in order to meet customer demands over the past decades. Further, our customers stay assured with the fact that SCHOTT has 14 other locations worldwide, from where we can bring in the additional capacity as and when required, to meet the rising demand.”
Analysing the market
The vaccine can be packaged in ampoules, vials and pre-filled syringes, but in the case of COVID-19, the preferred choice seems to be vials from all vaccine manufacturers. Since vials can have vaccines packaged in a single-dose vial or multi-dose vials, the demand is going to be high for multi-dose vials, which is usually 10 dose in one vial, for the COVID-19 vaccine.
Considering the global population, which is to be vaccinated — around seven-plus billion people — if the identified vaccine does not need a booster dose, then the requirement of multi-dose vials will be approximately 700 million units.
Mohan G Joshi, a global management consultant with a special focus on glass and pharma, and Ex-President, Strategic Adviser, SCHOTT Glass India, informed, “According to a recent newspaper report, SCHOTT, the world’s largest maker of speciality glass for vaccine vials has turned down requests from major pharma firms to reserve output. Instead, Dr Frank Heinricht, CEO, SCHOTT, would prefer “to keep the door open to give the capacity to those who really are successful in the end.” Regardless of the situation, no supplier of any raw material to any industry can afford to alter production or reserve output in anticipation of an eventuality, however eagerly it may be anticipated. While the entire humanity waits for the arrival of a vaccine to tame COVID-19, the availability of vials to house that vaccine seems to be the latest cause of concern.”
While rationalising the move of the global ancillary suppliers, Joshi commented, “What if the output is cornered by one or two companies and an altogether different company is first out with a proven product? In these difficult times, when every industry is picking itself up, it might appear safe and prudent to ensure cash flow by assuring production to whoever wants it. However, imagine the plight of the supplier if the world turns around and points fingers at them because they had reserved the supplies for the “wrong” producer.” As industry specialists are aware, a 10 to 20 per cent shortage in supplies boosts order flow by about 50 per cent. This, in turn, calls for an expensive increase in capacity that can take up to two years. This is a crucial decision, especially in the cost-intensive glass tubing and pharma packaging segments. When resources are scarce and the world is facing an extraordinary crisis, this decision becomes all the more critical.
There is a definite need for the entire pharma industry to gear up to serve humanity, not just the vial makers. Reputed companies like Schott and SGD Pharma are sure to allocate resources as required—if not for commercial gains, definitely to safeguard their reputation.”
To overcome the COVID-19 crisis, Joshi suggested, “Maybe, this is a good time to aggressively promote open innovation, where companies ought to forget their commercial differences and come together to step up capabilities. We have already seen that happening in the production of ventilators, sanitisers and masks. When life, as we know it, is at stake, rather than raising conflicts, it is more prudent to reach out and collaborate across walls.”