In an exclusive interview with Packaging360 team, Mr. Alagu Subramaniam, Managing Director at West Pharmaceutical Services, talks about the company’s operations and innovation for Indian Market and how it plans to adopt latest packaging technologies. He discusses the company’s approach in order to comply with stringent regulations & legislations in the EU and other markets.
The Managing Director of the US-based pharmaceutical packaging and delivery systems manufacturer throws light on the company’s technological capabilities and the products developed for Indian consumers. He also highlights few latest innovations in packaging as well as mentions quality & safety standards practiced by the company.
Alagu Subramaniam, Managing Director at West Pharmaceutical Services
P360: Please tell us something about the current status of the pharmaceutical industry in terms of adoption of latest packaging technologies?
Alagu Subramaniam: The global pharmaceutical market is rapidly evolving, driven by greater use of medicines, increased focus on personalized medicine and the emergence of innovative therapies for chronic conditions. Industry analyst firm QuintilesIMS predicts that global medicine spending will grow 4-7% and reach nearly $1.5 trillion by 2021. India is expected to be one of the top ten pharmaceutical markets by this time as access to healthcare increases and global and domestic drug manufacturers expand their footprint in the country.
Alongside this growth, there is increasing demand for high-quality packaging components across the pharmaceutical, biotechnology and generics markets as drug makers look to pair their injectable drugs with container/closure and delivery systems that can help ensure speed to market and competitive differentiation.
In India and around the world there are a number of trends driving the need for innovation and quality in injectable drug packaging and delivery. These include growth in generics and biosimilars as well as biologics, and an increasing demand for combination products. In addition, concerns for patient safety has led regulatory agencies to ask drug and packaging manufacturers to build quality into their products from the start, resulting in a move toward the use of a Quality by Design (QbD) approach to manufacturing.
P360: How are the pharmaceutical companies prepared to comply stringent regulations & legislations in the EU & other markets?
A.S: As noted above, concerns for patient safety have resulted in higher regulatory scrutiny and increasingly stringent requirements. At West, we have adopted QbD principles and applied them to packaging design and manufacturing which delivers an improved, data-driven output that can lead to a superior product. Utilizing a QbD approach can also help to minimize disruptions to the supply chain. By incorporating QbD principles into the development of packaging such as West’s NovaPure® components, drug manufacturers can be confident that the products they provide to patients are contained with packaging of the highest quality.
P360: Please tell us the technological capabilities of West Pharmaceuticals for the industry?
A.S: To help customers bring their products to market faster, West has established a comprehensive global supply chain network that includes the necessary infrastructure for the Asia Pacific region. Our plant in Chennai is fully operational and manufacturing various offerings from our product portfolio of seals, as well as elastomeric components and other offerings in response to regional market demands.
In addition to our primary packaging and device expertise, West offers a variety of integrated solutions designed to help customers at any point during the drug product lifecycle. We support customers with analytical testing, regulatory expertise and contract manufacturing services that can help to mitigate risk and simplify the supply chain.
In order to share the expertise and best practice for other pharmaceutical professionals in India, West launched the Knowledge Center last year. It provides scientific insight and detailed technical information on key areas of expertise, including technical reports, bulletins and science posters from West’s cross-functional team of scientists, engineers and technical experts, as well as respected industry organizations.
P360: What are the products developed especially for the Indian customer?
A.S: The generics market is an important area of strategic focus for India, and customers are looking for a global network to provide shorter lead times and faster time to market with higher performance products to meet increasing regulatory concerns. West developed the AccelTRATM Component Program specifically to meet these needs.
Designed to help customers stay competitive, the AccelTRA Component Program offers market-leading delivery times and a single, next-generation formulation for stoppers. In addition, the AccelTRA Program, which is built around the benefits of quality, speed and simplicity, can help generics manufacturers meet increasing quality standards, ensure fast response to market volatility and move product to market quickly. Available globally, the components meet global compendia requirements and have an industry leading E&L profile, offer optimized lead times and a global supply network, and are made from a next-generation formulation in RU & RS options.
P360: Please highlight a few innovations which would showcase customer-centric packaging from your company?
A.S: Self-administration and biologics have increased the popularity of combination products, such as wearable auto-injector systems used for the management of chronic diseases. One example is West’s SmartDose® drug delivery platform – a wearable, subcutaneous injector with an integrated drug delivery system that incorporates human factors and usability testing to deliver a truly patient-centric approach to self-administration. Auto-injectors, wearables and other new systems will only increase the already budding demand for combination products in the coming years as companies in India and Asia Pacific create them for local use and for export to the rest of the world.
Additionally, injectable formulations are significant for India, driven by investments in injectable development centers and newer injectable manufacturing capacities for complex biologics. While we have traditionally focused on marketing injectable container solutions in India, we now see the opportunity to further develop our drug delivery business here. Several customers in India have expressed interest in Daikyo Crystal Zenith® solutions–our technologically-advanced cyclic olefin polymer containment and delivery systems that offer an alternative to glass.
West is also seeing increased customer activity around our patient-controlled injection platform, the SelfDose™ injector, as companies seek technologies that make it easier for patients to self-inject. These and other initiatives are seeding the market for future growth.
P360: What are the quality & safety standards practiced by your company vis-à-vis global scenario?
A.S: The West brand is synonymous with quality, expertise and innovation. Our top priority is delivering quality products that meet the exact product specifications and quality standards customers – and regulators – require and expect.
To that end, West’s India manufacturing plants are GMP and ISO certified and employ sophisticated technologies to produce clean, sterile, high-quality pharmaceutical packaging components and drug delivery systems.
NovaPure®, AccelTRA™ and SelfDose™ are trademarks and registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.