Oral Solid Dose Manufacturing for Customers Now and into the Future

Despite all of the advances made in the biologics space, the majority of drugs on the market are formulated as small molecule APIs and administered orally. Catalent is continually investing to support the evolving needs of drug developers for state-of-the-art OSD formulation and manufacturing solutions.  

Listening to Customers

In the past, any contract development and manufacturing organization (CDMO) with an excellent reputation was highly sought after and attracted good projects — the same does not hold true today. The market is increasingly competitive, and sponsor firms are more frequently looking to establish strategic partnerships with CDMOs for specific needs. 

Catalent recognizes that the needs of drugmakers in the 21st century are very different from those of a few decades ago — and that they continue to evolve. We are listening to our customers and responding by implementing continuous improvement projects, adding relevant capacity and expanding our technical capabilities. By doing so, we add more services, provide more value as a long-term partner and drive costs down in development and manufacturing processes.

Winchester Facility Investments

In order to grow, it is often necessary to reinvent yourself. During the last five years, Catalent has invested over $105 million to ensure that our Winchester, Kentucky site is equipped to meet future demand. In addition to continuous improvement initiatives, we have completed compliance-related projects and added fluid-bed drying and encapsulation capacity. The facility also now includes a bottling line and has the ability to support pediatric formulations in stick-packs.

Capsule-banding technology was also installed at the site to support the move of prescription drugs to over-the-counter products, including the ability to band capsules as small as size 5. In response to increasing demand for next-generation controlled-release formulations based on osmotic release, we have also upgraded our laser tablet drilling system.

On April 30, 2019, Catalent announced it is to add commercial spray drying (SD) capability at the Winchester site. In total, we will be investing approximately $40 million over the next 12–18 months to increase patient-centric dose form capabilities, including expanding roller compaction capacity and adding a commercial spray dryer.

Controlled Substances Expertise

The Catalent Winchester facility has been offering controlled substance manufacturing services for over 20 years. Our impeccable record is the result of extensive investments in the process training, procedures and security systems required to account for every tablet and capsule and every last gram of API. 

OSD Solutions

Catalent is always looking for new technologies and approaches that will provide real value for our customers. In addition to traditional development and manufacturing solutions, we offer scientific, regulatory and clinical supply consulting services that help us serve as a comprehensive partner.

Specifically, for OSD customers with poorly soluble APIs (which account for up to 70% of pipeline candidates), our OptiMelt® hot-melt extrusion (HME) solution is an integrated offering that provides clients with a finished product — including bottling if desired. With our OptiForm® Solution Suite, Catalent provides a feasibility assessment of four technologies (lipid formulation in softgel capsules, HME, spray-dried dispersion or micronization) for improving solubility and bioavailability, all within 12 weeks. Because we offer all four solutions, Catalent has no incentive to choose one over the other; this agnostic approach will find the best fit for a customer’s API and can trim a year and sometimes more off the development cycle.

Integrated Offering

Catalent provides integrated services that support small, emerging and virtual companies, as well as large pharma firms. Our integrated, nimble network with end-to-end services supports smaller companies looking to partner or be acquired. For traditional pharma companies, in addition to aligning our supply chain management systems, we can serve as a strategic partner with all the same capabilities — plus additional specialized technologies — and simultaneously manage multiple products in their portfolios.

Focused on the Future

Catalent continually evaluates ongoing trends in the OSD marketplace. With the addition of patient-centric solutions, we support the development efforts of our customers, including for poorly soluble APIs and orphan drugs. 

In addition, with expertise in both oral solid dosage forms and biologics, Catalent is ideally positioned to help advance the development of oral novel delivery solutions for biomolecules. From orally disintegrating tablet technologies to intramuscular delivery solutions, Catalent has the integrated and evolving capacities required to solve the future challenges that will arise in the OSD field. 

Michael J. Valazza

Michael J. Valazza serves as Vice President of Business Development specializing in Oral Drug Delivery of traditional and modified release pharmaceutical dosage forms for Catalent Pharma Solutions, a position he has held since 2001. From 1997–2001, Mr. Valazza served as Vice President, Business Development for International Processing Corporation (IPC) in Winchester, KY USA, and as Director of Operations for IPC from 1992-1997. From 1986-1992, Mr. Valazza was Manager of Contract Manufacturing Services for Glatt Air Techniques. Mr. Valazza attended Rutgers University where he received a B.S. in pharmacy.