West has been experimenting with products to build vials that are compatible with many vaccines

Alagu Subramaniam, Senior Sales Director, West Pharmaceutical Services, Asia- Pacific, shares details about the company's contribution to the fight against COVID-19, the changing dynamics of the pharma packaging industry, technological advancements in pharma packaging and more, in an exclusive interaction with Lakshmipriya Nair
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How has COVID-19 changed the dynamics of the pharma packaging segment? What are the challenges for the sector as it navigates through the impact of the COVID-19 pandemic?

COVID-19 has drastically impacted the pharma packaging segment as it is directly connected with the manufacturing and supply of COVID-19 vaccines – the only recognised preventive treatment against the disease so far. The demand is huge and so is the pressure to deliver to market on time with a high standard of quality to ensure safe availability of vaccines.

In addition, the demand for common over-the-counter medication remains high. All this has resulted in tremendous growth for the packaging industry. In terms of the dynamics of the industry, the pandemic has ignited vast research and conversation on biologics and therapeutics treatment which is very critical for the pharma packaging industry.

Moreover, the need to innovate at a quick pace has led to never-witnessed collaborations and knowledge-sharing between companies.

In the case of vaccines packaging, keeping up with the accelerated timeline for vaccine approval has been a challenge as it has eliminated the standard development procedure. The time to ensure that all the right packaging containment systems are selected has been greatly reduced. The process must ensure that all kinds of risks related to leachables and container closures are mitigated. Given that different vaccines require different temperatures for storage – primary packaging components are crucial in preserving vaccines for a sustained period at the correct temperature.

With continued research in COVID-19 vaccines and the possibility of a different combination of vaccines, it has been a challenge to innovate products that work for all vaccines. For example, the mRNA and DNA are fairly new vaccine platforms, and so manufacturers must ensure that packaging is suitable for all vaccine platforms while also mitigating the risk of interaction between different chemical components of the vaccine.

What are the major lessons your organisation learnt from this health crisis and its management? How will it impact your future offerings, capabilities development for the life sciences sector?

Protecting the health and safety of team members and their families has been one of the most important priorities during the pandemic. At the peak of the pandemic, there were a lot of restrictions on mobility and the requirements of RT-PCR tests – all necessary measures to decrease the spread of the virus but complicated team management and manufacturing on-site. The continuity of supply was critical to meet the needs of vaccine demand, so management and site safety has been one of the greatest challenges and an opportunity for learning as well.

We developed 24/7 facility operations by increasing recruitment and training and had been one step ahead in securing raw materials to prevent avoidable delays in manufacturing. These processes have greatly increased our capacity in terms of manufacturing and have provided us with an operational roadmap on how to adjust to the demand for products quickly. West has also made capital investment through expansion of installed capacity in facility modifications, new equipment and reallocation. The investment is a signal of long-term goals and sustained demand for biologics and therapeutics in the future as well. West will continue to innovate, especially as we witness the development of new vaccines whether for COVID-19 or the new WHO-approved malaria vaccine.

Tell us about West’s contribution to the fight against COVID-19. What have been the recent innovations from the West which will fuel new efficiencies to fight the pandemic and beyond?

Since the pandemic began, West has been closely working with their vaccine-manufacturing partners to design packaging which is suitable for their vaccine platforms and formula. West has anticipated some challenges and has been involved in research to overcome them.

In terms of availability, there have been concerns of shortages of raw materials given the unanticipated demand. We witnessed massive limitations in the supply of glass vials, so we’ve been evaluating polymer-based containers. Cyclic olefin polymer vials have been studied at various biologics programmes and are potentially an excellent alternative to glass vials.

West has been experimenting with products to build vials that are compatible with many vaccines. For elastomers, we use a selection of the most powerful stoppers, which are basically laminated with ETFE film or our FluroTec barrier film. We have been greatly able to reduce the risk of leachable substances because of the chemical inertness, hydrophobicity, and tight chain packing of the fluoropolymer films like ETFE. As different vaccines require different temperatures to sustain, West use packaging materials that are compatible with a range of temperature to ensure the end-to-end safety of the vaccine. West doesn’t make vaccines, but we make sure they are packaged and delivered safely.

What are West’s technological advancements that are accelerating efficiency and improved outcomes in pharma packaging, especially vaccines? Is the Indian market prepared to leverage the potential of these advancements?

In 2019, West opened a Digital Technology Center in Bengaluru which serves as a global centre of excellence for the company’s Digital and Transformation (D&T) team. With the shift to digital over the last two years, the centre has become an important part of West’s efforts to enhance customer engagement through digital marketing, digital manufacturing and automation to accelerate internal and external business processes.

On 13th September, 2021, West launched the DeltaCube Modeling Platform, one of West’s exciting new digital innovations. It is an online vial integrity modelling system designed to help developers make faster, more confident decisions earlier when selecting vial, stopper and seal combinations. The DeltaCube Modeling Platform helps customers reduce risk and potential rework due to poor system fit. This leads to improved Container Closure System (CCS) integrity, faster product development and safer products.

What are the growth opportunities opening up in the life sciences sector, globally and in India? What are your strategies to leverage them? Any significant investment plans in the offering?

Globally, we continue to increase the capacity of our global manufacturing network to keep pace with increases in demand that we are seeing in both our organic business, as well as COVID-19 vaccine requirements. West has a part in seven out of 10 injections in the world and is engaged with more than 90 per cent of the companies in phase-III trials for a COVID-19 vaccine. We have committed to capital spend of >$265 million to date and we have hired over 1,000 new team members globally, since the start of this pandemic. We have accelerated investment plans to meet the demand for high-value products that include adding hundreds of pieces of capital equipment, molds and dies, and have introduced major facility expansions focussed across the globe.

In India, the vast majority of vaccine developers, as well as contract manufacturers, are using West products for their vaccine packaging for the domestic as well as for the export markets.

We also partnered with Venus Remedies to manufacture pre-filled 1mL long staked-needle syringes that are used with our NovaGuard safety system.

India is often referred to as the “Pharmacy of the World.” Indian companies are servicing almost 200 countries and West India plays an important part in partnering with these companies. Additionally, vaccines from India are being shipped all over the world – two out of three paediatric vaccines are currently being made in India. So, there is a growing biologics market and increased needs around the world and we intend to leverage that and make India a part of our growth.

lakshmipriya.nair@expressindia.com
laxmipriyanair@gmail.com

Alagu Subramaniampharma packagingvialsWest Pharmaceutical Services
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