On April 15, 2015 Catalent Pharma Solutions opened a large-scale expansion and investment at its Winchester, KY, manufacturing facility, doubling its footprint to 180,000 sq. ft. Catalent says increased customer demand for the manufacture of complex, oral solid formulations spurred the $52 million project.

Opened in 1992, the Winchester facility has evolved into one of the industry’s premier sites for advanced oral controlled-release drug formulation and manufacturing. The site has more than 20 years of experience in product development, technology transfer and commercial manufacturing, with roots in industry-renowned Glatt technology. It has produced over 3 billion tablets and capsules annually, and launched over 100 new products into the market since its inception.

Construction work on the expansion began in 2013 with a $35 million facility investment, followed by subsequent investment in additional fluid bed capacity. The expansion also features expanded analytical laboratories and an open facility design the company says will provide flexibility in supporting the requirements of new customer programs.

The project will add as many as 90 new employees at the site and has potential to add further employees and capabilities as it attracts customers for its advanced oral dose manufacturing solutions.

The expansion was officially opened by Lieutenant Governor of Kentucky, Crit Luallen, during a ribbon cutting ceremony. Afterwards, Contract Pharma sat down and talked with Catalent’s president and chief executive officer, John Chiminski, about the project and what it means for the present and future of one of the leading global providers of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.

—TW

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Contract Pharma: What were the motivating factors behind the expansion?
John Chiminski: Winchester has a strong brand and reputation in the market place, and we have seen high customer demand for our manufacturing solutions and have been operating the site at near capacity levels for the last few quarters. The expansion allows us to meet this demand with additional fluid bed and analytical capacity, as well as the flexibility to customize the space to meet any customer’s program requirements. We are in discussions with a number of customers about utilizing the expertise of this team with complex oral solid development and supply to create unique fit-to-task solutions for major marketed products and anticipated major launches.

CP: What makes this facility unique and how does this new expansion add to that?
JC: Winchester has a deep history in fluid bed granulation, coating, and high sheer processing, with expertise in modified release, multiparticulates, solvent-based products and controlled substances.

The facility can produce over 3 billion tablets and capsules annually, with more than 6,000 kilograms of multi-particulate daily processing capacity utilizing Glatt technology, which is the site’s foundation. Since its inception, Winchester has launched over 100 products, with numerous technology transfers successfully completed at all phases of the product lifecycle.

CP: What are the new features?
JC: The $52 million expansion doubles Winchester’s footprint to 180,000 sq. ft., including a new fluid bed, large analytical lab, and ability to provide integrated specialty packaging services. The expanded space provides the flexibility to handle large volumes, and the open footprint and large interstitial space also offer flexibility in designing custom or dedicated suites based on program requirements.

CP: What goals does Catalent have set for the new facility?
JC: The new facility allows Catalent to respond quickly and efficiently to customer demand for complex oral solids supply solutions, and to be flexible in how we support program requirements by offering customized suite options. With the new capacity we can also expand our share of higher volume production, and we are currently in discussion with multiple customers for manufacturing of substantial marketed products.

CP: What sort of capacity are you looking to achieve?
JC: Winchester has historically produced over 3 billion tablets and capsules annually. Following the expansion we will have doubled the facility footprint, added two fluid beds, which increases our large scale fluid bed capacity by 33%, and substantially expanded our analytical lab space. Our overall capacity will depend on the product mix and cycle times required to support our customers’ programs. 

CP: What is Catalent’s strategy for oral solid drug delivery solutions for the next several years?
JC: Catalent is positioned to offer a full breadth of technology platforms and services across a product’s lifecycle, with an expansive global footprint. We will continue to develop and optimize our existing oral solid delivery technologies, such as the particle size engineering capability we acquired from Micron, our Optimelt Hot Melt Extrusion technology, Optidose for unique release profiles, and Zydis ODT fast dissolve technology with dissolution less than three seconds. We will expand on these existing platforms. For example, we are looking at innovation around oral delivery of large molecules, as well as ways to increase the drug load and optimize taste masking for our Zydis platform. 

We will also remain focused on the quality and operational excellence required to successfully develop, manufacture, and launch our customer’s products.  Catalent has extensive development capabilities globally for our core business of complex oral solid formulations, and proven expertise in technology transfers and product launches for both small- and large-scale programs. We will continue to grow this supply side of our business, executing against the highest quality standards. And we will look for opportunities to expand or strengthen these capabilities in response to customer and industry demand. In addition to the expansion of our Winchester facility, we have also invested in expanding high potent handling capabilities at our company headquarters in New Jersey, to support the large proportion of highly potent compounds in today’s pharmaceutical pipeline. And our recent acquisition of Micron Technologies, as well as our global hot melt extrusion platform and open alliance with BASF, shows our commitment to offering comprehensive solutions that solve our customers’ bioavailability challenges.

CP: What do you attribute to the growth in activity in solid dosage form?
JC: We are definitely seeing an increase in demand for generics as marketed products come off patent, particularly in Europe where price pressures are significant. In the U.S., the specialty pharma segment remains strong, but from companies of all sizes, there is continued demand for modified release and other complex formulations across both branded prescription and consumer health products. With fewer blockbusters in the pipeline, companies are taking a more targeted approach to treat narrower disease states or patient populations, or looking to improve upon existing marketed products with next generation treatments that offer more optimal results. More and more compounds in the pipeline have more complex delivery profiles, including precise release requirements, combination of different APIs, delivery needs in specific parts of the body for increased efficacy as well as increased demands from payers and patients for convenience in administration, pill burden reduction and adherence. So the market is increasingly demanding better treatments. 

With the right oral delivery technologies and development expertise, that goal can be achieved. Innovative oral solid products can offer flexibility in timing of medication release, reduce side effects, optimize dosing schedules, drive patient adherence, or address the unique needs of certain patient segments such as paediatrics or the elderly, or individuals that may have trouble swallowing. These types of advanced drug delivery forms offer distinct marketing and brand advantages, while adding clear value for patients.
 
CP: What key technologies is Catalent investing in?
JC: From an oral solids standpoint, Catalent has invested in Optimelt technology for hot melt extrusion, and in both U.S. and EU we have established end-to-end HME delivery platforms. This HME offering along with our softgel and micronization capabilities provides a suite of solutions to address our customers’ bioavailability challenges. Our Zydis ODT offers adherence and swallowability benefits with less than three second dissolution, and we will continue to invest in the Zydis platform to achieve higher drug loading and optimal taste masking. We have invested in Optidose technology for unique release profiles as well as combination and dividable formats. Across our core controlled release offering, we will continue to build additional fluid bed, granulation, coating, and high sheer processing to support our customers’ needs. We also have invested in high potent manufacturing capability in our Somerset, NJ facility, as well as controlled substance manufacturing and high potent storage here in Winchester.

As a company, Catalent is investing across its full spectrum of technology offerings. The Advasept glass-free injectable technology platform is expanding, with a new product to be announced at Interphex. We also have developed Optigel Bio for oral delivery of large molecules, Optigel Lock for anti-abuse, and many other technologies across both oral and injectable dose forms.

CP: What are Catalent’s geographic interests for solid oral dosage form?
JC: Catalent is currently present in the U.S. and EU for its oral solid development and manufacturing business, with three commercial facilities in the U.S., and two facilities in Europe, one of which is our Zydis production facility. In addition we have 11 softgel development and manufacturing facilities in U.S., Europe, Australia, Japan, China and South America.

CP: What does the client base look like? Are you seeing more interest from large pharma/biopharma or smaller, specialty companies and/or emerging companies?
JC: Catalent works with a wide range of customers, from the smallest biotech to the largest pharma companies. In Winchester we have established very strong relationships with both specialty and large pharma. Historically the majority of our Winchester business has been with the specialty mid-tier segment, but with our increased capacity, we are also engaging in more discussions with large pharma around higher volume products. The expansion provides us the flexibility to work with customers and programs of all sizes. Overall, Catalent has relationships with 49 out of the top 50 pharma companies including long-standing top supplier relationships with many, as well as with over 1000 smaller innovators. We pride ourselves on skills to deliver differentiated tailored services to both sets of customers.

CP: What are sponsors asking for these days with regards to solid dosage form? 
JC: Customers want to develop better treatments, whether through more optimal release profiles, less invasive dosing regimens, reduced side effects, better swallowability, or other mechanisms to improve efficacy, adherence, or the patient experience. They also want to solve product challenges such as bioavailability and absorption. Drug delivery technologies that offer unique release profiles, solve bioavailability challenges, offer combination or dividable formats, and provide more effective or convenient ways to get the right amount of a drug into the right part of a patient’s system at the right time are in high demand. Also, oral delivery of macromolecules and abuse deterrence are hot topics of conversations and development work. 

CP: What are some of the current challenges with solid dosage form development?
JC: Bioavailability issues are a common theme in today’s market, with 70% of drugs in the pipeline classified as poorly soluble. One challenge in optimizing the solubility of a molecule is that it often requires a multi-faceted approach to optimize the API, optimize the formulation, select and optimize the processing technology, and develop the desired marketed product form, such as tablet or capsule. In many cases, the impact on resulting solubility is co-dependent across these factors. Another challenge is in delivering drugs that are broken down by low pH in the stomach. Tailored enteric coating or resistant capsules containing minitablets or pellets are a potential solution for local gut delivery and improved systemic availability. Then there are also the challenges of controlling release, tailoring delivery, preventing abuse, and ensuring patient adherence.

CP: Are there other services/businesses that Catalent is expanding into?
JC: Catalent has made a number of advancements in new areas. The recent acquisition of Redwood Bioscience and SMARTag ADC technology shows our commitment to the high growth biologics space, an important business for Catalent and a critical growth driver for the future of the company. The Micron Technologies acquisition broadened our portfolio of bioavailability solutions to include particle size engineering. We also are investing in capabilities such as high potent handling, and in high growth regions such as China, Japan, and Latin America. We are also building out expanded capabilities for helping our customers deliver orphan and breakthrough designated therapies with faster, integrated solutions. Our internal research and development areas are focused on improving technologies to provide better treatment options for our customers’ patients including macromolecule oral delivery technologies, glass free injectables, better combination or flexible dosing options in oral delivery, improved fast dissolve options with better taste masking for larger doses and more.