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A conversation with the CEO and president of JHS about the company's continued growth and the emerging trends shaping the CDMO landscape.
Released By Jubilant HollisterStier CMO
December 9, 2024
Jubilant HollisterStier (JHS) has established itself as a leading player in the contract development and manufacturing organization (CDMO) space. Under the leadership of CEO and president, Chris Preti, the company is making significant strides in expanding its capabilities to meet global demand for complex formulations and sterile injectables. In this interview, Chris shares insights into the company’s ongoing expansion, its strategic approach to scalability, and its commitment to maintaining the highest standards of quality and compliance. With a history of innovation and adaptability, JHS is poised to address both current challenges and future opportunities in the pharmaceutical manufacturing industry.
From a $300 million expansion in Spokane, WA to strategic investments in cutting-edge technologies and biologics manufacturing, JHS is pushing the boundaries of what is possible in pharmaceutical production. Chris highlights how the company’s dual-site strategy, robust project management systems, and strong regulatory track record allow it to remain agile in an evolving market.
Contract Pharma: Can you tell us more about the recent expansion of Jubilant HollisterStier’s manufacturing capacity in Spokane? What additional capabilities will this expansion bring to Jubilant’s portfolio?
Chris Preti: JHS is doubling its capacity with two additional state-of-the art production lines, expanding our manufacturing potential and supporting job growth in the Spokane, WA community. We are excited for the opportunity to meet a growing need, utilize the latest available technology, and respond quickly to future pandemics.
Line 3 is equipped with full isolator technology and three additional compounding suites. Isolator technology ensures the excellent level of quality and safety our partners need and can scale alongside production campaigns and reduce the risk of contamination by ensuring no human interaction with the product during manufacturing. We have finished the first phase of expansion and are currently scheduling time with customers on line 3.
We’ve broken ground on constructing line 4, which will be ready by 2026. The 160,000 sq. ft. expansion and the addition of larger lyophilizers will open opportunities for us to better service customers by expanding operations. The line 4 expansion will also include additional operational space with a build-out, loading docks, ultra-cold storage and temperature-controlled capabilities, a high-speed packaging line, environmental monitoring, stability space, and a new employee services area. Once line 4 is live, JHS will be able to produce over 60 million vials and service over 300 million patients annually around the world.
CP: With rising demand for complex formulations, biologics, and sterile injectables, how is Jubilant positioned to support scaling operations and what strategies are in place to ensure flexibility and responsiveness in production?
Chris: For each individual customer project, JHS assembles a technical team with expertise in every aspect of process development. The team works closely with our partners to lay out a scale-up strategy by leveraging their experience using a diverse set of raw materials that behave in unique ways. This could begin as a simple mixing study and scale-up confirmation batch, or in more complex cases, as an engineering batch and re-validation. Focusing on quality as well as the compliance to the critical attributes of those products and employing stringent manufacturing practices places scalability and adaptability at the heart of any project. The key for customers is high-quality production in a consistent and reliable manner.
During the COVID-19 pandemic, we stayed agile despite multiple urgent projects requiring novel solutions. Thanks to our highly tenured workforce, we were prepared to overcome potential challenges that would impact the timeline and to still keep compliance and quality as our highest priorities. While the industry average for cold storage solutions takes an average of 16 months to procure, we were able to do it within 90 days. During another project, our turnaround time from signing the contract to patient administration was less than 6 months.
CP: How is Jubilant managing scalability to ensure that increased capacity does not compromise quality, compliance, or efficiency in operations?
Chris: JHS invests in our technology and our people. Our onsite employees have an average tenure of seven years, and JHS is proud of the expertise and knowledge they bring to any project. As we grow our facilities, JHS is committed to providing additional training to develop the abilities of our team members. 92% of our partners are return customers, and we will keep manufacturing quality products at the level our partners know to except.
Our best-in-class project management system includes five stages for each project: initiation, planning, execution, monitoring/controlling, and closure. Using this process every time guarantees a project finishes without mistakes. Because our teams consist of long-standing JHS employees practiced in multiple aspects of the CMO process, our clients know those managing their products fully understand the ins-and-outs of what will make the project successful.
JHS is routinely inspected every two years by the FDA and value the oversight they provide. We also have a successful compliance history with many other major international regulatory agencies, including:
• Health Canada• ANVISA in Brazil• EMEA in the EU• MOH Turkey• MOH Russia• TGA in Australia• PMDA in Japan• MFDS in South Korea
CP: What trends or challenges are you seeing in the supply chain for complex formulations and sterile injectables? How is Jubilant responding to these issues to minimize disruptions and ensure continuity?
Chris: We’ve built resiliency into our own supply chains by drawing from a diverse network of suppliers who have proven their ability to maintain quality and regulatory standards. Conducting risk assessments, employing predictive analytics, and keeping a safety stock of critical materials helps us keep the production line moving in the face of potential disruptions. Products like vaccines and biologics require strict temperature control during storage and transportation. As the demand for cold chain logistics increases, JHS continues to acquire advanced temperature monitoring and refrigeration capabilities to preserve product integrity.
The U.S. government and JHS entered a partnership to bolster the domestic availability of patient therapies and vaccines in the case of another public health emergency. As part of our $300 million expansion to create lines 3 and 4, the federal government contributed $149.6 million to expand critical vaccine manufacturing. Furthermore, having two sites across Montreal and Spokane helps us meet the needs of customers desiring redundancy in North America.
CP: Looking forward, are there additional areas in the CDMO landscape—such as high-potency drugs, biologics, or other specialized formulations—where Jubilant sees potential for growth or further expansion?
Chris: The COVID vaccine’s success helped launch RNA therapeutics into the mainstream, and innovators have been successful in the past few years using small molecule and biologic drugs to target a broad range of disease states. At JHS, we’ve invested in biologics and small molecule manufacturing process and can produce offerings for our partners like therapeutic peptides, non-replicating and non-live vaccines, monoclonal antibodies, several kinds of hormones, and antifungals.
As we continue to expand our capabilities and set new benchmarks for excellence, we remain focused on delivering innovative solutions, fostering meaningful partnerships, and serving patients worldwide.
Learn more about Jubilant HollisterStier>>>>>
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