April 12, 2019 PAP-Q1-2019-CL-009
The ongoing provision of innovative drug development and manufacturing solutions requires continual investment in advanced technologies, equipment and facilities. Having recognized that pharmaceutical customers are seeking rapid and cost-effective proof-of-concept services combined with GMP production capabilities, UPM relocated from our original location in Baltimore, Maryland and into a former Pfizer manufacturing site in Bristol, Tennessee. We then invested $12 million to expand production suites and modernize the facility, plus over $1 million to create a Solids Formulation R&D Facility. At present, UPM is a full-service contract development and manufacturing organization (CDMO) capable of producing solid and semisolid products from 100 g to approximately 1 ton annually.
Our facility in Bristol has segregated storage for non-GMP raw materials and suites for R&D, pilot and commercial manufacturing. For solid products, four R&D production suites include the equipment required for dry and wet granulation, compression and encapsulation processes. Our similarly equipped pilot plant comprises 11 different manufacturing suites for the production of up to 30–50 kg of product, depending on the process. Some of these suites are designed to allow production under low-humidity (15%) conditions for air- and moisture-sensitive APIs.
Our commercial facilities include granulation and high-speed compression, coating and encapsulation capabilities. The UPM Bristol plant is also equipped to perform small- and large-volume bulk production of semisolids, including creams and ointments in tubes and vials. We also have a long and successful track record of producing controlled substances and potent compounds across all scales.
Supporting all of these activities is our full-service, in-house analytical laboratory. Our laboratory allows for method development for raw material release, API and drug product characterization, stability testing, in-process testing and product release. The lab includes all of the necessary state-of-the-art analytical instrumentation necessary to meet current GMP testing requirements. Our most recent investment was the purchase of a mass spectrometer and detector for inductively coupled plasma analysis of elemental impurities.
Three high-speed packaging lines in the plant enable bottle packaging for many products. The ability to offer final product manufacturing and packaging in one facility helps clients streamline their supply chains and reduce time to market. For clients that wish to extend support beyond drug product manufacturing and packaging, UPM also has a separate 250,000-ft2 warehouse and provides warehousing and distribution services.
While UPM is best known as an early-stage development company with extensive expertise in solid and semisolid dosage manufacturing, over the last several years we have had numerous projects advance from the proof-of-concept stage to commercial production. At the same time, UPM has continued to build relationships with both large, well-known pharmaceutical companies and small and medium-sized growing drug manufacturers. We have been quite pleased to see our business grow by ~100% and expect it to double once again within the next two to three years.
As UPM has moved from a small to a medium-sized full-service CDMO supporting small molecule oral solid and semisolid dosage forms, we have only begun to fill the available capacity at our Bristol facility. Within our existing ~225,000 square feet of manufacturing space, we are positioned to bring in new business without creating any conflicts with our existing client projects. Indeed, we continue to possess significant flexibility to incorporate new projects into the manufacturing schedule. Wait times tend to be a few weeks compared with months at some CDMOs.
We have the capability to produce 700 million capsule units and 3.5 billion tablet units per year. Currently, we are utilizing about 30% of this production capacity and will reach 50% over the next two years, leaving ample room to grow with respect to new projects. While we are near 100% capacity for production of semisolids in jars, we have significant capacity available for semisolid products filled into tubes. Furthermore, we have significant available real estate at the Bristol site and are willing to partner with clients to design customized manufacturing facilities and equipment trains under the appropriate conditions.
Technical flexibility is essential for developing effective, safe and robust formulations and manufacturing process solutions for the challenging drug candidates moving through the pharmaceutical pipeline. UPM has established expertise in a number of different complex chemistries and delivery technologies. This includes highly potent compounds, different types of controlled substances, oral peptide therapies and modified-release technologies and dosage forms. We have worked on successful applications for particle coating, sustained-release matrix tablets, tablets with modified-release coatings and complex combination products.
UPM’s dedicated team of technical and manufacturing experts has nurtured many projects from the proof-of-concept stage and into commercialization over the last two years, which is a clear demonstration of our extensive expertise in early-stage formulation development and commercial production for solid and semisolid oral dosage drugs, including immediate- and controlled-release products.
In fact, UPM has built-in flexibility for addressing the challenges that arise through process development and commercialization. Although we take a structured approach that includes assignment of each client project to an interdepartmental team headed by a project manager with daily scheduling meetings, UPM is able to quickly respond to changing client and market demands. The team keeps close track of the project and provides routine communication with the client regarding all activities. We also have the operational capability to respond to unexpected manufacturing issues.
Behind everything we do at UPM is the understanding that our clients are committing significant monetary resources to the projects that we undertake. They have timelines that must be met, and we are cognizant of this and share their goals while striving to minimize the risks associated with each project. We also understand that projects rarely proceed without encountering glitches along the way. That is why UPM has designed support systems that, while structured, also have the flexibility necessary for the rapid response needed to accommodate unexpected issues.
UPM employs an experienced group of scientists and engineers that work on technology transfer; each has a background in formulation, manufacturing equipment, process development, scale-up and validation. Our heads of formulation and manufacturing, for instance, have over 40 and 30 years of experience in the industry, respectively. On average, our staff has 5–25 years of experience in formulation development and technology transfer, managing projects from the ground floor. In addition, we take a collaborative approach to our projects, with frequent internal discussions on technical issues and troubleshooting to leverage our knowledge and provide value-added work to our clients.
At UPM, we are excited to be growing with our clients. When we moved into the Bristol facility, many of our clients had projects in the phase I or phase II stage. Over the years, UPM has helped take these early-stage projects into commercial production. As a result, we are now focused on enhancing our services for the bulk of our clients, who are now involved in later-stage development projects. In addition to supporting scale-up and the production of registration batches, we are now serving as a primary commercial supplier for products already on the market. However, we will continue to provide early-stage support for legacy clients and for promising new projects.
One of the steps we have taken to provide better service is to combine our early- and late-stage R&D groups into one unit, which more fully leverages the talents of our highly skilled and experienced staff. We have also established a clearer review process for incoming project requests to ensure that we can give each project the level of attention required. Both moves have helped UPM to reduce complexity and allow us to better focus on the services that are becoming a larger part of our business.
We are also excited to see the business at the Bristol plant, which was originally owned by King Pharmaceuticals, a company founded by the Gregory Brothers, continue to flourish for the benefit of the local community. Some risk was taken by UPM when acquiring the facility, but we were committed to growing our CDMO operations in order to reestablish a strong business in the community that provides high-technology jobs and will be an important contributor to the local economy for many years to come. We have turned the corner on successfully transitioning from an early-phase contract service provider and are now eagerly cementing our position as a full-service CDMO in support of late-stage and commercial development and manufacturing of oral and semi-solid dosage drugs.
James E. Gregory has served as the President and Chief Operating Officer of UPM from 2004 until the present. Gregory previously worked for King Pharmaceuticals from 1995 to 2000 as Executive Vice President and General Manager of King’s Bristol, Tennessee manufacturing facility. He served in various consulting capacities at King from 2000 to 2003 and served on the Board of Directors in 2002 and 2003. Gregory served from 1982 to 1995 as a senior administrator in the court systems of Phoenix, Arizona and Washington, D.C. He was deputy executive officer in charge of business operations of the District of Columbia Court System from 1990 to 1995. Gregory has a B. A. from the University of Maryland and a Masters in Public Administration from American University.