As one of the leading contract development and manufacturing organizations (CDMO) providing drug delivery technologies and development solutions, Catalent offers worldwide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. With over 11,000 employees, including more than 1,800 scientists, Catalent works with over 1,000 customers to produce 73 billion doses of nearly 7,000 products annually. This equates to approximately 1 in 20 doses taken each year by patients or consumers around the globe.In the last two years Catalent has made two major acquisitions. First, in 2017 the CDMO purchased Cook Pharmica’s facility in Bloomington, IN, expanding its biologics development capabilities. In 2018, the company acquired the UK-based Juniper Pharmaceuticals, an early-phase development and manufacturing company.Contract Pharma had the chance to sit down with Catalent’s president of oral drug delivery, Jonathan Arnold, to talk about the challenges and opportunities the company faces and its growth in early development and new technologies.Contract Pharma (CP): Describe the Juniper deal and how it expands Catalent’s early phase capabilities.Jonathan Arnold (JA): In August 2018, we acquired Juniper Pharmaceuticals, Inc., including its Nottingham, UK-based Juniper Pharma Services division. The $133 million acquisition expands and further strengthens Catalent’s offerings in formulation development, bioavailability enhancement solutions and solid oral dose manufacturing, and complements our integrated downstream global clinical and commercial supply network.The Nottingham facility now acts as a European center of excellence for early phase development and its nearly 150 employees, who have deep scientific expertise in formulation development and supply, are now fully integrated within the Catalent organization.The Nottingham facility specializes in solid-state characterization and preclinical formulation screening for lead-candidate selection, phase-appropriate dose-form development, and formulation technologies to address challenging molecules, which further strengthen and expand on our capabilities to accelerate clinical development and offers our customers’ opportunities to begin optimizing formulations earlier and potentially reducing the risk of failure later in development.CP: What are some other business highlights over the past 12 months?JA: Earlier in 2018, before we acquired Juniper, we also announced that we were investing $5 million in the creation of a focused drug development center of excellence at our Somerset, NJ facility and headquarters. The site will focus on preclinical to clinical phase 2b formulation, analytical, and manufacturing solutions for orally delivered small molecules, as well as specializing in the development of modified and controlled release formulations. The investment will build upon the site’s expertise in clinical dose form strategies, and its handling capabilities for potent compounds, and will provide many of the same capabilities as its sister sites in Nottingham UK and on the west coast of the U.S., in San Diego.Alongside the new centers of excellence, we are implementing systems that ensure the seamless tech transfer of programs downstream into our late-stage clinical and commercial manufacturing sites. This includes a process of harmonizing raw materials; specifications; analytical methods; environmental, health and safety considerations; and mirrored manufacturing equipment for improved scalability and project management systems. The goal is to provide greater speed, cost efficiency and reduced risk to projects as they progress through the clinic to commercialization. Our San Diego site has successfully transferred multiple development programs to our Kansas City, MO site for late stage scale-up, which led to cost and time savings compared to external transfer to a different provider.CP: What are some of the most pressing challenges facing the industry and CDMOs in particular?JA: At Catalent we continue to see a growing need for solutions that improve the bioavailability of poorly soluble new chemical entities. We have built up a wide-ranging portfolio of capabilities to enhance oral bioavailability, including development of amorphous dispersions with spray drying and hot melt extrusion, particle-size reductions with micronization and nano-milling, and lipid-based delivery systems.We aim to match the best technology for clinical success using an agnostic, data-driven process, where the formulation and dose strategy is driven by the attributes of the particular molecule, the manufacturing process intended, key patient acceptance factors, and our customers’ strategic product goals.Today’s drug development pipeline is increasingly complex, and molecules with delivery challenges are commonplace. With many programs now driven by small, venture-capital backed companies without the resources of large pharma, finished dose outsourcing will increase. The number of new drugs approved per billion U.S. dollars spent is falling, mainly because of a lack of efficacy, often discovered at phase 2 or later, when significant resource has already been invested. The industry needs to focus on those programs that offer the best chance of the molecule reaching, engaging with the target, and eliciting a desired response, and killing other programs before spending more on them. It’s far too expensive to develop all candidates that show promise, and that is why customers often turn to development partners to help get to a scientifically based “go/no go” decision quickly.There is increasing recognition that for a patient to comply with their dosing regimen, we need to make drugs in forms that aid their compliance all the way to the end of the course of treatment. While it was once sufficient to be able to treat a condition, there is an increasing focus on how patients can continue to live a normal life with their condition. Many patients endure having to take multiple medicines at whatever prescribed interval throughout the day, that may be hard to swallow, taste awful, or induce some undesirable side effect, but apply those same conditions to the young, the old, or the already infirm and most would agree we need to find better treatment technologies.CP: What are some of Catalent’s most recent technological breakthroughs?JA: We have recently developed the Zydis Ultra oral disintegrating tablet (ODT), which builds on the Zydis fast dissolve tablet technology. Zydis Ultra technology involves a novel API coating technology to increase drug load per unit dose. The advantages of ODTs over conventional oral dosage forms are well established and documented and are principally related to improved patient compliance, adherence and convenience. These are particularly evident within such groups as pediatrics, geriatrics and mental health patients who more frequently have problems swallowing tablets.However, a significant challenge with ODT dosage forms is the formulation of APIs with an extremely bitter taste or a propensity to cause stinging, burning or numbing within the mouth. Usually, ODT drug loading is limited to 100 mg per dose, however, Zydis Ultra technology overcomes this through the use of a patented API coating technology that draws on both acoustic mixing/coating and lyophilization. It will therefore significantly broaden the number of molecules that can potentially be formulated using Zydis ODT technology, and this next generation of ODTs will have broad industry potential to improve patient compliance, adherence and convenience, as well as expanding the applicability of the ODT platform to a greater range of compounds.To date, industry response has been overwhelmingly positive, and we have now entered proof-of-concept programs and full development with several customers, for both over-the-counter and prescription therapies.
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Early Development Trends – Contract Pharma
