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Talking small molecule trends with the CEO and CCO of recently launched Navin Molecular.
October 1, 2024
By: Tim Wright
Editor, Contract Pharma
Navin Molecular was launched in 2023 as the CDMO business of Navin Fluorine to support its customers with development and manufacturing capabilities for small molecules, across a wide range of chemistries, with the ability to support projects from early-stage development through to commercial manufacturing. Its aim is to redefine itself as what it terms a “next-generation” Indian CDMO, at the forefront of providing quality services to its customers, alongside the leading global providers. With a state-of-the-art facility in Dewas, India, the company has extensive expertise in hazardous chemistries, including high-pressure, highly energetic chemistries, direct fluorination and numerous additional competencies, and provides innovative solutions for the manufacture of complex molecules—and to cGMP standards as required. Its mission is to expedite customers’ programs through technology-driven development and manufacturing in a collaborative partnership model. In June/July 2024, the company announced an expansion with the construction of a new, 9,000-square-meter GMP manufacturing plant, which will nearly double overall capacity at the site, and will support existing commercial-scale projects, as well as meeting future demands as the company continues to expand its global customer base. Contract Pharma had the chance to talk with Navin Molecular’s chief executive officer, Rajendra Kumar Sahu, and chief commercial officer, Jordi Robinson, to discuss the launch of the new CDMO business, how the company’s growth strategy will support the small molecule development market, and how it is evolving to meet the ever-changing needs of its global customers. Contract Pharma: What was the strategy behind the launch of the new CDMO business in 2023? Rajendra Kumar Sahu & Jordi Robinson: We branded our CDMO business as Navin Molecular to showcase the broad platform that the company can offer in terms of world-class facilities and strong expertise across the full range of complex chemistries in the manufacture of advanced small-molecule intermediates. Historically, the company’s strength has been in hazardous and challenging chemistries, but our skills serve all customers that are seeking reliable, fast and cost-effective custom synthesis and manufacturing services. Our goal is to allow customers to build a geographically diverse supply chain that operates to internationally recognized standards for quality, safety and the environment. We offer manufacturing partnerships to global innovators, building on the history and heritage of our expertise in fluorination. Our site in Dewas provides GMP-quality products as a standard, which allows us to be extremely flexible with partners who require additional steps. We can also back-fill processes without compromising on quality. CP: What is the current state of the small molecule market? Rajendra & Jordi: The development pipeline for small molecules continues to be very strong, despite the emergence of new therapeutic modalities and the continued growth of biological drugs. The economics of small molecules will continue to see them as the option of choice for first-line treatments in most cases. New technologies in the design, manufacturing and formulation of drugs have allowed innovators to access new molecular space, with the potential benefits of greater efficacy and reduced side effects for patients. Where we have seen the greatest change in the market is in the attitude of customers and their demands on suppliers. The pandemic has left a legacy in two areas: supply chain security, and the perceived speed of development. During the pandemic, there was an over-reliance upon outsourcing in both development and manufacturing, along with the fragility of supply chains. This has led to many companies, particularly those based in the U.S., scrutinizing their supply chain networks, and looking to focus on ensuring strategic partnerships with companies in diverse geographical regions. Ongoing geopolitical uncertainty has led to rising costs for both energy and consumables, and with China perceived as dominant in the industry for outsourcing and raw materials, there is a marked shift in attitudes to outsourcing. Many big companies are employing a “China +1” approach, whereby at least one of the material suppliers has to be non-Chinese. This has led to increased opportunities for Indian CDMOs such as Navin Molecular that can offer high-quality, flexible services to fill the gap. The modern supply chain model balances geographic locations alongside traditional factors such as delivery time, quality and cost. The pandemic showed how rapidly the industry can adapt and accelerate projects under extreme conditions, and this has led to pressure being put on suppliers to provide extremely competitive lead times for projects, especially for early-phase programs. Whereas price was once the most important factor when considering a proposal, opportunities that could accelerate projects are now at a premium. CP: What are the advantages of customers looking to India for development and manufacturing? Rajendra & Jordi: India remains economically advantageous in comparison with its competitors, although costs have been rising, in part because of intense pressure from Chinese CDMOs. The bigger and more established Indian CDMOs have made huge advances and investments over the past decades, and their facilities would rival the infrastructure and quality seen in the west. As well as excellent facilities, India boasts a large, educated workforce. Its lower cost base facilitates flexibility and expansion as necessary. One of the traditional roles that Indian outsourcing partners have fulfilled in pharmaceutical intermediate manufacturing is the provision of technologies in specialist areas such as hazardous chemistry. Rising costs and safety legislation mean these services are almost exclusively outsourced and, through its parent company, Navin Molecular has built up world-leading and cost-effective infrastructure in areas such as fluorination and high-pressure chemistry. Historically, customers may have outsourced only these individual steps, but as the company’s reputation has grown, customers sought to outsource additional stages around the hazardous steps. This was the foundation for what Navin Molecular offers today. CP: How have CDMOs such as Navin Molecular had to adapt to growing demands and needs of customers? Rajendra & Jordi: The outsourcing market is crowded and means that CDMOs must differentiate themselves. With customers looking for more secure and streamlined supply chains, manufacturers need to be able to offer a wider range of services and technologies to fulfil the wide range of demands. Being able to meet the growing pressure on delivery timelines is particularly important. The reliance on a smaller supplier base has shifted the outsourcing model from a purely transactional one towards a partnership relationship. Despite the increased pressure for competitiveness, the likelihood that a long-term, mutually beneficial relationship will result is increased. For this, however, the onus is on CDMOs to be more agile and flexible, and willing to invest in new technologies, capabilities and capacity. Navin Molecular continues to invest in high-quality manufacturing facilities, with its latest expansion nearly doubling our capacity. The site in Dewas has additional space to allow further growth and investment as the market evolves. We offer GMP-regulated services as a standard and are equipped with technologies to ensure the most efficient manufacturing possible, backed up by analytical and quality protocols to ensure the highest-quality of service for our customers. CP: What are the global challenges that the industry faces, and what can/is Navin Molecular doing to address these? Rajendra & Jordi: As previously mentioned, time is the greatest challenge for innovators. Outsourcing partners must not only be technically competent and offer economic advantages, but also be in a position to work within ever-increasing time constraints. This means having capacity available—and, crucially, the correct capacity—as well as being flexible. The lower cost base in India allows CDMOs in the country to work to lower occupancy levels than would be viable in the west. This means they often have additional capacity available to take on additional work at short notice, and it is easier to expand and grow as customer demand increases. On a wider industry platform, sustainability remains a huge challenge for the manufacturing sector. In today’s market, the standard expectations for suppliers to be competitive in areas such as price, lead time and material quality are taken as a given. Increasingly, additional factors are being used in the selection process, including the supplier’s approach to sustainability. Manufacturing is both energy- and resource-intensive, and at Navin Molecular we looked at our environmental impact and are committed to a long-term strategy to minimize it. Our environment management and energy management systems are accredited with ISO 14001:2015 and ISO 50001:2018 respectively, and our site has been awarded EcoVadis bronze certification. Although manufacturing volumes have increased at the site since 2021, our sustainability initiatives have resulted in annual energy consumption decreasing by nearly 14%, and water by about 6%, which were achieved by adopting technologies that are more efficient. Over half of the waste generated at Navin Molecular is recovered through recycling and re-use processes, with hazardous waste pre- or co-processed for use as fuel, rather than being sent to a disposal site. ESG parameters are also factored into our supply chain management logistics, with more than half of our input materials sourced from neighboring districts to further cut the environmental impact of shipping. CP: What is next for Navin Molecular as it continues to grow and evolve? Rajendra & Jordi: Although the brand is relatively new in the market, it is backed up by decades of experience in providing the highest quality manufacturing services for customers. The expertise we have in complex and hazardous chemistries is the backbone for the model we are promoting to customers looking for long-term relationships. Our secure, diverse supply chains are attractive to the industry, and we have several key relationships with innovators and global pharma companies that benefit from the value of high-quality, economically advantageous suppliers. The CDMO market is in constant evolution as it reacts to the demands of drug development. Small molecules continue to be a mainstay within the industry, and we must look as a supplier to ensure that our investments and services match these, whether through flexible capacity or new technologies, to ensure manufacturing can be as efficient as possible.
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