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Single-use systems are increasingly used in pharma as market trend shifting to biosimilars, cell therapy: Expert
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Shardul Nautiyal, Mumbai
September 13 , 2023
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Single-use systems are increasingly used in pharma manufacturing due to market trend shifting from APIs and complex generics to biosimilars, cell therapy and gene therapy, informs Ritesh Patterson, general manager, Performance Plastics, Saint-Gobain India.
Saint-Gobain India provides silicone and thermoplastic tubing for pharma, biopharma, medical, molded parts for medical devices and equipment, single use bags, liners and assemblies for biopharma and pharma industries and also filters for pharma and industrial applications. The company offers a complete range of silicone tubing accompanied by well-formulated documentation providing customers with both information and assurance.
Patterson explains that these systems offer advantages such as time, cost savings and reduced contamination risks. Manufacturers need to be mindful of the materials they choose for their processes, ensuring limited extractables and leachables, and compliance with regulations.
“Free Trade Agreements (FTAs) will also assist us as they provide significant advantages to the buyer countries. Over the past two years, we have been exporting to customers in the US and Europe, which has been a great advantage for India. We took advantage of this opportunity to establish ourselves as an export hub, offering an alternative to the US and European source plants,” Patterson further explains.
The company produces a wide range of 2D and 3D bags with capacities ranging from 50 millilitre (ml) to 3000 litres (l). These bags can be manufactured using fully automated or semi-automated setups, allowing for efficient production processes.
Patterson further says that these product differentiations, both in terms of tubing functionality and assembly offerings, contribute to competitive edge in the market. By focusing on these key areas, we demonstrate our commitment to meeting customer needs and providing tailored solutions. Indeed, the importance of localization setups and Capex aligning with industry outlook cannot be overstated. By investing in setups that correspond to the growth segments of the industry, we position our company to capitalize on emerging opportunities.
According to Patterson, the company’s strategy of establishing setups in different geographies is a prudent measure to mitigate supply chain disruptions. By replicating manufacturing processes and plants in multiple locations, such as the US, India, and Europe, it ensures business continuity even in the face of calamities or disruptions.
He explains that India as a production hub was used for mainly Asia, excluding China, because China has a manufacturing setup of their own for our product range. So, we were already giving products to Singapore, anywhere in Southeast Asia. Bangladesh is also an important pharmaceutical cluster, which is emerging pretty much there. We are covering it as an extension of India, and it is like we have our own sales team operating out of there. Anything in the Indian subcontinent is what we call our own and for our calculation purposes, we talk about maybe Singapore, Southeast Asia and all those places as exports for us. What happened in Covid was because we had capacity available in our Silicone and thermoplastic extrusion.
“When we have already exported to international clients, especially significant players in regions like the US and Europe, it becomes advantageous in countries where we don't have local manufacturing facilities. For example, let's consider Australia. By catering to Australia's needs, we have positioned ourselves as a credible production hub. This means that products previously sourced from the US can now be shifted logistically to India. This crisis presents us with an opportunity to expand our export footprint. It could include countries such as Australia, Korea, Japan. The company is already supplying to Taiwan. To support these endeavors, we are prepared and investing in additional silicon extrusion and thermoplastic extrusion lines. Our clean rooms will have increased capacity and capabilities. We have already approved one Capex and are extending our resources to ensure that we can serve these export markets effectively,” Patterson further said.
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