Sunday, 28 November 2021

"Gearing up on Capability & Capacity enhancements to meet evolving needs of Pharma & Biopharma customers"

30 October 2021 | Views

Saint-Gobain India, a part of the French multinational firm, is a leader in providing glass and glass solutions. But, it is also active in other high-performing sectors that include Performance Plastics (PPL) in Life Sciences. From being leading producers of Performance Plastics to association with pharmaceutical companies for providing medical equipment, to even foraying into the electric vehicles segment in India, the PPL- Life Sciences have been aiming for strong growth. During an interaction with BioSpectrum, Ritesh Patterson, General Manager, Performance Plastics, Saint-Gobain India, Bengaluru shares his insights about the company's strategies in the biopharma and medical industries. Edited excerpts;

What are the major contributions at Saint-Gobain India towards the growth of the life sciences industry?

Life sciences industry in India has built strong capabilities across parts of the value chain to emerge as a big export hub for production of generic drugs and vaccines. In manufacturing, India continues to have the largest number of United States Food and Drug Administration (USFDA) approved plants outside the USA along with a large number of contract development and manufacturing organisations (CDMOs).

Saint-Gobain Life Sciences division has a product portfolio of tubing, single use bags, assemblies, filters and connectors used by pharmaceutical and biopharmaceutical customers for manufacturing life-saving drugs like vaccines, monoclonal antibodies, injections, eye drops etc. Our products play a vital functional role in transfer of these drugs from production to finish and final fill vials and ampoules ensuring sterility and high yields of their end products.

The Indian pharmaceutical industry is expanding its product range towards development of oncology and hormonal products requiring products providing inertness towards harsher chemicals. Saint-Gobain Life Sciences India has a local manufacturing setup for Platinum cured Silicon and Thermoplastic polymer tubing at Bangalore delivering a comprehensive range of products for these diverse requirements of inertness. Our local manufacturing presence ensures customised tubing, shorter lead times for product development and commercial supplies for our customers. In addition, biopharma and pharma customers need validation data to assess the fitness of a given product for their manufacturing processes and risk assessments for submission to regulatory agencies. Our material formulation competencies and validation studies provide them support to meet these stringent regulatory standards of agencies like USFDA, European Medicines Evaluation Agency (EMEA) or European Medicines Agency (EMA) and Drugs Controller General of India (DCGI).

The Medical Component division under Life Sciences has a specialised portfolio of precision injection molded parts, small diameter precision tubing and other sub-components of medical devices which are used in various surgery and diagnostic equipment.

 

What are your latest innovations in this space?

Research and Innovation are at the heart of Saint-Gobain’s strategy. The Group’s research focuses both on breakthrough innovations and on continuously improving its products, processes and services in a spirit of openness and attentiveness to customer needs.

Single-use systems (SUSs) are becoming increasingly common in bioprocessing operations because of their low capital requirements and validation costs. As this trend continues to develop, pharmaceutical manufacturers are asking SUS manufacturers to provide assurance that their products comply with current good manufacturing practices (CGMPs) and do not alter drug products by exceeding established operating ranges.

Our competency in material formulations and developing conceptual design for single use manifold and assemblies helps our customers to eliminate manual connection leading to faster batch turnaround times, yield improvements and minimise risk of contamination. In addition, our enhanced level of tubing validation certification offers a higher level of quality assurance in single-use fluid handling components. Saint-Gobain validates the fluid path of the tubing and single use manifold to meet the USP & ISO standard industry requirements.

 Strategically designed cell culture, processing and preservation systems will pave the way for the next generation of potent 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 to emerge as a preferred partner for these evolving requirements of the Life Sciences sector.

 

Did the pandemic bring in a change in business perspective towards the life sciences sector?

COVID-19 has been a disruptor for all business sectors and that applies to the life sciences sector too. The expected lead times for development of vaccines and drugs have been drastically reduced through excellent collaboration between different stakeholders. The agility required to crash these developmental lead times has forced manufacturers and suppliers to collaborate closely for an efficient supply chain for drug manufacturing.

The significant take away from this crisis is that local manufacturing of consumables for pharma, biopharma and medical industries has gained impetus. Saint-Gobain Life Sciences with its strong local manufacturing footprint in India combined with application expertise and material formulation competencies was able to support these emerging requirements of shorter lead time requirements of product development and commercial supplies. Our local presence enabled strong collaboration with all COVID-19 vaccine manufacturers in India during the pandemic and helped us establish our products for their production lines, ensuring timely supplies to meet their tight production schedules.

Another emerging requirement in all business sectors including Life Sciences is usage of digital platforms to create awareness of products and services, technical and commercial engagements through knowledge sharing has gained traction. Saint-Gobain Life Sciences too is undertaking initiatives for deployment of multiple digital touchpoints to facilitate a seamless customer experience in their various interactions with us.

 

How was the company's performance in the last fiscal and what are your projections for FY 2021-22?

We have had a strong growth in the last fiscal year driven by a surge in demand from both domestic and export customers. Considering the current demand scenario in the Life Sciences market on both domestic and export front we would expect a strong result for FY 2021-22. We are currently at 100 per cent capacity utilisation and are in the process of significant capacity and capabilities enhancement both globally and in India which should help us gain market share and service these strong growth of life sciences customers.

 

What are your investment plans for the Indian life sciences market?

Saint-Gobain Life Sciences manufacturing setup in India currently has two dedicated class 7 cleanrooms to manufacture silicone tubing, thermoplastic elastomers tubing and silicone molded parts. We have investment plans to expand our capacity for both silicone and thermoplastic elastomers tubing by putting additional extrusion lines for servicing domestic and export requirements. 

We have an ongoing investment in our Bangalore plant to produce single use bags and assemblies for our biopharma and pharma customers from the second half of 2022. In addition, we would be investing in state-of-the-art silicone molding presses to enhance our capabilities to produce molded parts for biopharma and medical industries.

 

Are you planning any new launches for 2022?

Saint-Gobain Life Sciences has augmented its product portfolio through recent acquisitions of Netherland based company, Equflow B.V and a French company, MS Technique & Transluminal.

Equflow is producer of Flowmeters, a product used in precise measuring flow of liquid that meet the strict requirements and comply with USP Class VI high quality standards. These products complement our bioprocess solution portfolio and there are potential applications across our Fluid Transfer and Medical businesses.

MS Technique & Transluminal have competency in high-precision thermoplastic extrusion and design expertise for minimally invasive catheter solutions with a strong focus into the cardiovascular market and it provides us a unique opportunity to cater to the emerging needs of domestic catheter manufacturers and assemblers.

Both these product lines would be formally available in the Life Sciences product portfolio to service customer requirements in FY2022.

 

Sanjiv Das

(sanjiv.das@mmactiv.com)

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