"Enhanced readiness and capacity to meet the changing needs of pharmaceutical and biopharmaceutical customers"

2021-11-25 04:25:20 By : Mr. Sam Xiao

Saint-Gobain India is part of this French multinational company and a leader in providing glass and glass solutions. However, it is also active in other high-performance fields, including high-performance plastics (PPL) in life sciences. From becoming a leading producer of high-performance plastics to cooperating with pharmaceutical companies to provide medical equipment, and even entering the field of electric vehicles in India, PPL-Life Sciences has been committed to achieving strong growth. During the interaction with BioSpectrum, Ritesh Patterson, General Manager of Saint-Gobain High Performance Plastics, Bangalore, India, shared his insights on the company's strategy in the biopharmaceutical and medical industries. Edit excerpt;

What are the main contributions of Saint-Gobain India to the development of the life science industry?

India’s life sciences industry has established strong capabilities in all parts of the value chain and has become a large export center for the production of generic drugs and vaccines. In terms of manufacturing, India continues to have the largest number of US Food and Drug Administration (USFDA) approved plants outside the US and a large number of contract development and manufacturing organizations (CDMO).

The Saint-Gobain Life Sciences division has a product portfolio of pipes, disposable bags, components, filters and connectors, which are used by pharmaceutical and biopharmaceutical customers to manufacture life-saving drugs, such as vaccines, monoclonal antibodies, injections, eye drops, etc. Our products play an important role in transferring these drugs from production to finished products and final filling vials and ampoules to ensure the sterility and high yield of the final products.

The Indian pharmaceutical industry is expanding its product range to develop oncology and hormone products that need to provide inertness to more demanding chemicals. Saint-Gobain Life Sciences India has a local manufacturing facility for platinum cured silicon and thermoplastic polymer pipes in Bangalore, and can provide a comprehensive range of products to meet these different inert requirements. Our local manufacturing operations can ensure customized pipes for our customers and shorten the lead time for product development and commercial supply. In addition, biopharmaceutical and pharmaceutical customers need to verify data to evaluate the suitability of a given product for their manufacturing process, and need to submit a risk assessment to regulatory agencies. Our material formulation capabilities and validation studies provide them with support to meet these requirements from agencies such as the U.S. Food and Drug Administration, the European Medicines Evaluation Agency (EMEA) or the European Medicines Agency (EMA) and the Indian Drug Administration (DCGI). Strict regulatory standards.

The medical component department of Life Sciences has specialized precision injection molded parts, small-diameter precision tubes and other sub-components of medical equipment for various surgical and diagnostic equipment.

What is your latest innovation in this field?

Research and innovation are at the core of Saint-Gobain's strategy. The Group's research focuses on breakthrough innovation and continuous improvement of its products, processes and services in the spirit of openness and attention to customer needs.

Due to its low capital requirements and verification costs, single-use systems (SUS) are becoming more and more common in bioprocessing operations. As this trend continues to evolve, pharmaceutical manufacturers require SUS manufacturers to ensure that their products comply with current Good Manufacturing Practices (CGMP) and will not change drugs beyond the established operating range.

Our capabilities in material formulation and development of conceptual designs for single-use manifolds and components can help our customers eliminate manual connections, thereby reducing batch turnaround time, increasing yield, and minimizing the risk of contamination. In addition, our higher level of pipeline verification certification provides a higher level of quality assurance for disposable fluid handling components. Saint-Gobain validates the fluid path of pipes and disposable manifolds to meet USP and ISO standard industry requirements.

 Strategically designed cell culture, processing and preservation systems will pave the way for the next generation of effective cell-based cancer therapies and vaccines. Our life sciences business unit produces a variety of disposable products for these promising new therapies, including cell culture and processing bags, and becomes the partner of choice to meet these evolving needs in the life sciences field.

Has the pandemic changed the business perspective of life sciences?

COVID-19 has always been a disruptor in all areas of business, and this also applies to life sciences. Through excellent cooperation between different stakeholders, the expected delivery time for vaccine and drug development has been greatly shortened. The agility required to shorten these development lead times forces manufacturers and suppliers to work closely together to establish an efficient drug manufacturing supply chain.

The significance of this crisis is that local manufacturing of consumables in the pharmaceutical, biopharmaceutical and medical industries has been promoted. Saint-Gobain Life Sciences, with its strong local manufacturing footprint in India, combined with application expertise and material formulation capabilities, can support these emerging requirements for product development and commercial supply of shorter lead times. During the pandemic, our local presence allows us to work strongly with all COVID-19 vaccine manufacturers in India and helps us build our products for their production lines, ensuring timely supply to meet their tight production plan.

Another emerging demand for all business sectors, including life sciences, is to use digital platforms to increase the visibility of products and services, which has gained attention through knowledge sharing technology and commercial participation. Saint-Gobain Life Sciences is also taking steps to deploy multiple digital touchpoints to promote seamless customer experience in various interactions with us.

How did the company perform in the last fiscal year, and what is your forecast for the 2021-22 fiscal year?

Driven by the surge in demand from domestic and export customers, we achieved strong growth in the last fiscal year. Taking into account the current domestic and export demand in the life sciences market, we expect strong performance in the 2021-22 fiscal year. We are currently at 100% capacity utilization and are significantly increasing our production capacity and capacity globally and in India, which will help us gain market share and serve these strong growth life science customers.

What is your investment plan for the Indian life science market?

The Saint-Gobain Life Sciences manufacturing facility in India currently has two dedicated Class 7 clean rooms for the manufacture of silicone tubes, thermoplastic elastomer tubes and silicone molded parts. We have investment plans to increase our extrusion production lines to meet domestic and export demand, thereby expanding our production capacity for silicone and thermoplastic elastomer pipes. 

Starting in the second half of 2022, we will continue to invest in our Bangalore plant to produce disposable bags and components for our biopharmaceutical and pharmaceutical customers. In addition, we will invest in the most advanced silicone molding machines to enhance our ability to produce molded parts for the biopharmaceutical and medical industries.

Do you plan to launch any new products in 2022?

Saint-Gobain Life Sciences recently expanded its product portfolio by acquiring the Dutch-based company Equflow BV and the French company MS Technique & Transluminal.

Equflow is a manufacturer of flow meters, which are used to accurately measure liquid flow, meet stringent requirements and meet USP Class VI high quality standards. These products complement our portfolio of bioprocess solutions and have potential applications in our fluid transfer and medical businesses.

MS Technique & Transluminal is capable of high-precision thermoplastic extrusion and design expertise for minimally invasive catheter solutions, with a focus on the cardiovascular market, which provides us with a unique opportunity to meet the emerging domestic catheter manufacturers and assemblers need.

Both of these product lines will be officially used in the life science product portfolio in fiscal year 2022 to meet customer needs.

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