The world awaits a vaccine to vanquish the novel coronavirus. But, finding or developing it is only half the battle. Succeeding in the Herculean task of ensuring access to the vaccine and enabling immunisation at an unprecedented speed and scale will be crucial to winning the war against this pandemic. So, it is important to keep the pharma industry in a prepared mode to achieve this goal.
Readying for the future
This translates into a huge challenge and an opportunity, not only for the vaccine makers but also for their partners. Meeting the massive demand that will arise for glass vials, is a case in point. Therefore, some leading glass packaging partners in India divulge how they are increasing their preparedness to meet the demand.
Khasim Saheb, MD ‑ Primary Packaging Glass India, Gerresheimer informs, “Type1 glass manufacturers are ready to serve the pharma sector for COVID-19 vaccination. Gerresheimer India is tripling its capacity of tubular glass by end of 2020 and doubling its capacity of moulded vials by end of 2021. We are also making strategic investments in adding capacities in terms of equipment and technology.”
“2 ml Type1 tubular glass vials, 3 ml moulded vials are most favoured for vaccines currently, but moulded glass Type 1 vials are also used, especially for multi-dose vaccines. Multidose vaccinations with 10 ml, 20 ml, 30 ml and 50 ml moulded vials can be an immediate solution in case of a shortage of vials. We have sufficient capacity of moulded glass Type1 vials available too,” he apprises.
However, admitting that the demand for vials is likely to go up significantly, he states, “Though it is difficult to assess accurately at this point of time, the demand is likely to be in billions for a couple of years after a vaccine is discovered. Therefore, reputed pharma companies are securing capacities for 2021 and 2022. We have given the inventory/capacities of our spare capacities to several pharma companies,” updates Saheb on the global scenario.
But, he also assures that Gerresheimer is continuously expanding its capacities as part of its strategic growth plan globally and is ready to serve the pharma industry and COVID-19 vaccine requirements.
Rishad Dadachanji, Director, Schott Kaisha divulges, “Schott Kaisha has been pro-actively expanding its production capabilities over the past years, including an investment of around 50 million euros since last year. With its newest facility in Umarsadi (Gujarat), it is already manufacturing over three billion pieces of ampoules, vials, syringes and cartridges annually. The upcoming facility at Baddi, Himachal Pradesh will be Schott Kaisha’s fourth manufacturing plant that will further add to our production capabilities.”
“We are confident that we can quickly expand our production capabilities in case the demand arises. In fact, as a joint venture with the world’s leading and largest manufacturer for tubular glass and containers, the technology group SCHOTT AG, we have the further strength to bring in additional capacity from their 14 other locations worldwide, if required. There are no challenges hindering any further ramp-up. Pharma has been a focus sector for India over the past years, and the overall growth has led to a conducive environment for expansion for its packaging industry as well,” he adds.
Explaining why his outlook for the future is optimistic, Dadachanji says, “India’s position within the global pharma segment has strengthened over the years as part of its vision to become the world’s pharma hub. The global pharma packaging industry has also been growing rapidly, and now it is even more important to ensure ample supply of high-quality glass packaging products, for drugs manufacturers all over the world. In fact, SCHOTT KAISHA itself has a contribution of about six per cent towards the global supply of glass packaging products, as it supplies more three billion pieces out of approximately 50 billion pieces produced and sold globally per annum.”
He updates, “We do not foresee any vial shortage. We are in a very strong position to meet our customer’s current and anticipated requirements. For instance, we are the only company to manufacture and supply sterile ready-to-fill glass containers in the country.”
Vijay Shah, Vice Chairman of Piramal Glass also concedes that there will be a large demand for glass vials but it will be difficult to quantify at this point in time since it will depend on the form and the dosage of the vaccine. However, he assures, “There are news articles which are mentioning that there will a huge shortage of glass vials and glass vials will be a key problem area for the industry. I will like to dispel that misunderstanding. There won’t be any shortage.”
Explaining why, he elaborates, “Piramal Glass makes Type 1 moulded borosilicate glass vials. There are only four major moulded glass suppliers in the world, including us, but we have sufficient capacity. We have a furnace which has the capacity of producing 40 tonnes per day, and two of our competitors in India would also have capacities of another 40 tonnes. So, we are roughly 50 per cent of the India market. When the need arises, we can easily meet the rise in demand since we have another furnace which can be converted to manufacture Type 1 glass. This will double our capacity. Our competitors can also double their capacities. So, we don’t foresee any shortage.”
He also points out that moulded vials are often manufactured and stocked beforehand while that is generally not the case with tubular vials which are made to order. He also highlights that moulded glass is a better option for multidose vials, which will be a good option to enhance access to the vaccine.
Shreevar Kheruka, MD, Borosil informs that a lot of CAPEX has been spent on upgrading facilities/infrastructure in value and volumes at his company in the recent past. He says, “Currently, we have the capacity to manufacture 250 million tubular glass vials. We can triple this capacity at our current location by installing the needed equipment. Moreover, we have upgraded our machines with state-of-the-art features and up-to-date technology to offer best in class packaging solutions which are manufactured with no human intervention.”
He points out that scientific glass is about 25 -30 per cent of the company’s portfolio. While it is not the biggest player in pharma glass packaging, it has a sizeable share.
Speaking on the opportunities and the company’s preparedness to leverage them, he emphasises, “We estimate the demand caused by COVID-19 in the first year will be around two billion. As the cost of production in this country is best in the world, a lion’s share of filling the vaccine once it is developed can come to India. Therefore, we have lined up large investments in this segment and is well prepared to supply for any vaccine or drug.”
Thus, glass vials manufacturers are quite confident in their abilities to support and meet the requirements of India’s pharma sector.
This is fortunate since industry stakeholders and observers share the outlook that as one of the largest producers of vaccines in the world, India can leverage its manufacturing expertise and technical infrastructure to become partners of choice for global companies to ramp up the global supply of safe, reliable and cost-effective COVID-19 vaccine.
Partnering global inoculation
Kiran Mazumdar Shaw of Biocon, speaking at a recently organised virtual event, stated, given India’s vast capabilities in vaccine production it can become a “very important strategic partner” in facilitating global inoculation. After all, the world will require massive volumes of vaccines at affordable costs!
Dr Prasanna Deshpande, Deputy Managing Director, Indian Immunologicals, explains, “To address the COVID-19 pandemic crisis, two large tasks are ahead of us – one is to research and develop a safe and effective vaccine. Second is to scale up and manufacture that vaccine in large quantities to enable supply for large segments of the population. India can play a significant part in the latter task given that technical expertise exists to manufacture a safe and effective vaccine while complying with national and global regulations. Vaccines industry in India has a proven track record of globally supplying large volumes of vaccines for immunisation programmes as well as trade markets. ”
“India’s has the advantage of cheap labour and availability of raw material required for bulk production of the vaccine. The above preparedness will go a long way in enabling access to COVID-19 vaccine across the world. It already has a head start with some domestic companies undertaking bulk manufacturing even before completion of clinical trials,” points out Arvind Sharma, Partner at Shardul Amarchand Mangaldas & Co, a leading law firm which works with the pharma sector, amongst others.
At least half a dozen domestic vaccine makers are in the race to develop a COVID-19 vaccine and many like Serum Institute of India have already entered into licensing agreements and partnership arrangements with leading biotech companies and universities to deal with the present global health crisis. Of the total WHO-listed vaccines being developed worldwide, at least three are being manufactured in collaboration with Indian companies.
Moreover, COVAXIN, an indigenous vaccine candidate for COVID-19, developed by Bharat Biotech in collaboration with ICMR-NIV recently got DCGI approval for Phase I & II Human Clinical Trials. “The world is going to need multiple vaccines to be able to overcome this challenge of COVID-19. We (India) are good at manufacturing but we need to prove to the world that quality vaccines and R&D is possible in India. I will consider it a big success for Science in India if COVAXIN is successful. Bharat Biotech can strategically play a role in keeping our vaccines affordable and available to all countries,” says Dr Krishna Ella, Chairman and MD, Bharat Biotech.
Sharma reminds, “It is notable that India has supported the European resolution at the World Health Organization to ensure “universal, timely and equitable access to all necessary products for countering the pandemic”. Therefore, India should step up its efforts in international cooperation, enter into partnerships and establish effective distribution networks.”
Hopefully, the measures taken by packaging partners would be a step in this direction. It would go some way in alleviating a potential shortage which would hamper the distribution of a COVID-19 vaccine, especially since India’s role in enabling access to it across the world could be a starring one.
|The global scenario: A snapshot|
|Pharma companies and public health activists raised concerns about a possible shortage of vials which will create a serious bottleneck in the distribution of COVID-19 vaccine once it is discovered
In turn, global glassmakers, Stevanato Group, SCHOTT, and Gerresheimer committed to supporting future COVID-19 vaccine with pharma containers. They also assured to support the pharma industry’s priorities for overall medication supply in addition to COVID-19 drugs.
Yet, fears of shortage led to manufacturing deals and partnerships such as:
|Alternatives to glass?|
|Glass is the most preferred material for vaccine fill and finish because of its inert nature which prevents interaction with the drug, its resistance to delamination, durability and robust structure. At this point in time, there are no proven scalable alternatives to glass when it comes to primary packaging of high-end pharma products like vaccines
But, mounting fears about a potential shortage of glass vials have kindled an interest in alternative technologies like polymer vials and pre-filled syringes manufactured using blow-fill-seal technology.
To cite an example, Honeywell recently launched Aclar Edge, a pharma packaging solution for oral liquids for human health and sterile injectables for animal health applications.