Catalent recently acquired Pharmatek Laboratories. What does this acquisition bring to Catalent and how does it help the company’s current and future clients?
The Pharmatek acquisition brings spray drying into Catalent’s portfolio of drug development technologies, and expands our formulation development and early phase manufacturing capabilities. With the addition of spray dried dispersions, Catalent now offers a comprehensive suite of bioavailability enhancement services, an important consideration for our customers given that most molecules in development do face bioavailability challenges. Following the acquisition, Catalent’s OptiForm Solution Suite, a science-driven screening approach, includes the full suite of technologies required to help identify an optimal formulation pathway for poorly soluble compounds.
Pharmatek’s expertise in early phase development also strengthens our ability to work with customers as early as at the pre-clinical phase. That early phase development then connects seamlessly into Catalent’s established clinical supply and commercial manufacturing network, ultimately helping our customers bring more products to market with an efficient, integrated drug development and delivery platform for both oral and injectable dose forms. In addition Pharmatek’s San Diego location provides convenient access for both West Coast and Asia Pacific customers.
This is a very strategic acquisition for Catalent and reflects our continued commitment to offer the most comprehensive solutions for our customers throughout their drug development process. Together we will help our customers unlock the full potential of their molecules and provide better treatments to patients.
Spray drying has been around for some time. Why is it only recently that it has become a “go to” technology to optimize drug delivery? What are some recent technological advances that have made spray drying an ideal technology for drug development and drug delivery?
Spray drying is not new to the industry and has been used for many applications, but it does offer clear benefits for early phase development, particularly when considering bioavailability enhancement, which again represents an issue with the majority of drugs in today’s development pipeline. Spray drying is ideal for assessing whether amorphous dispersion is the most optimal development path for a poorly soluble molecule because relative to other technologies, it generally requires less time, is less costly, and requires less API. Growth in inhalation and controlled release oral technologies is another driver behind increased demand for spray drying, as the technology also offers consistent particle size distribution, long-term stability, and higher drug loading, and enables taste masking and controlled release profiles.
It is also important to have an integrated spray dry offering. In San Diego, Catalent can provide rapid development from prototype to optimal final dose form, with integrated characterization, analytical, pre-formulation, formulation, process development, and cGMP manufacturing. In addition we offer co-located downstream processing technologies, and precise critical process parameters to support regulatory submission expectations. Our spray dry suites also offer containment for highly potent compounds, another area where we see increased market demand due to growth in oncology drug development.
What are some complementary technologies to spray drying that can make spray drying more effective? How do these technologies get used/integrated into the overall drug development/drug delivery process?
Products utilizing spray dry technology are also likely to require roller compaction, a capability that Pharmatek has established in San Diego, and that Catalent offers in its existing network through to commercial scale. Inhalation products often use spray drying as well, and this is an opportunity to integrate spray drying with Catalent’s inhalation development and manufacturing platform.
Catalent offers a wide range of drug delivery optimization services. In general, how easy are these services able to be scaled-up and specifically how easy is it to scale-up spray drying services for commercial manufacturing?
Through the Pharmatek acquisition, Catalent offers a full spectrum of spray dry capability from early development through Phase IIb cGMP production. For R&D and small scale cGMP, we have a Buchi , GEA Niro® SD Micro, and a ProCepT, all of which can effectively scale up to our GEA Niro Mobile Minor® spray dryers for later phase clinical cGMP manufacturing. Our Mobile Minor spray dryers utilize a closed-loop system which translates to easier scale-up and tech transfer to larger scale commercial spray dryers. We do not have commercial spray drying in the network today, but will address the strategy for commercial manufacturing as the current spray dry business progresses through development.
Looking ahead, how will Catalent leverage its spray drying expertise for current and future clients, and are there any other technologies the company is looking at to enhance its drug development/delivery services?
Catalent is committed to providing our customers with comprehensive solutions that help them recognize the full potential of their molecule, and bring better treatments to their patients. We will leverage spray drying as part of our OptiForm Solution Suite for bioavailability enhancement, along with our lipid-based formulation expertise, micronization, salt form screening, and hot melt extrusion. Together these technologies provide a comprehensive, agnostic approach to help identify the optimal formulation path, after which we can subsequently take our customers through dosage form development and cGMP manufacturing. We will also utilize spray drying for tailored solutions across oral and inhaled dosage forms, and develop a commercial spray drying strategy based on customer needs.