Capsugel announced in early September that the company will be expanding the capacity and capabilities of its Quakertown, PA facility to increase its micronization services output for clinical and commercial manufacturing—the very same facility that Capsugel acquired in January of this year.
Capsugel acquired Xcelience and Powdersize in January 2016, the latter of which its Quakertown facility originated from. Providing particle-size reduction and particle-size control/classification technologies, the acquisition of Powdersize expanded Capsugel’s suite of bioavailability enhancement tools.
But with the expansion close on the heels of the acquisition, not only will the company have additional capacity for manufacturing operations, but product lead times are expected to improve by up to 75 percent.
“By bringing Powdersize into the business model, we have the ability to be a much more relevant and flexible partner for our customers,” said Amit Patel, Sr. Vice President, Capsugel. “Often times, when customers come to us with certain challenges on formulation or drug delivery, it’s important for us to be able to bring multiple solutions to the table from which we can jointly determine what might be the best approach. And I think micronization was a missing link for us (as part of our overall solubility offering).”
Anywhere between 60 and 90 percent of molecules that are being discovered in development or commercialized, according to Patel, have some degree of solubility challenge to them.
“When we were unfolding the Capsugel dosage form business model, we already had a number of technologies that addressed solubility—amorphous dispersions, including spray-dry dispersions, lipids, liquids, nanoparticles, and so on,” Patel said. “But micronization is one other technical means by which one could potentially achieve improved solubility. That’s really the focus that Powdersize has had for many years, and, from our perspective, as we brought Powdersize into the business model, it was a very complimentary offering that we were able to provide.”
The Importance of Solubility
“We’ve always had a fairly strong emphasis around bioavailability enhancement and solubility as an area that a lot of our technologies address,” said Patel.
When looking to expand its bioavailability and solubility solutions, the company studied the trends in the market place—specifically the thematic questions being asked, such as:
- Can solubility help formulate complex formulations that achieve the desired target product profile?
- Can micronization be done under a high-containment environment so that the handling of certain types of APIs is done appropriately?
- How does one look at multiple different technological approaches to achieve improved solubility so that the team can take a scientific approach as to what is the most appropriate one (or what combination of technologies are most appropriate)?
“These are some of the themes that we’ve been sensing in the marketplace. As part of that, our acquisition of Powdersize has allowed us to expand our offerings and be that much more helpful to many of our customers,” said Patel.
Micronization as a First Resort
A large portion of Capsugel’s customers work in R&D—with the new projects that are brought on board tending to start at the clinical, or development, phase.
“Micronization tends to be the first-resort approach,” Patel explained. “If someone has a project in R&D, the initial attempt might be to see whether or not that particular API can be micronized. If it can and that achieves the desired outcome, then additional technologies might not be required. Other times, it’s a combination of micronization and other technologies (or evolving into other technical approaches).”
To determine how to best address a customer’s need, Capsugel looks at a host of criteria, including:
- What defines a particular API?
- What type of formulation is being developed?
- What is the target product profile that a customer is looking to achieve?
“We apply a number of different criteria to see what other technologies may be relevant. But the options would include anything from lipids and liquids, to spray-dry dispersions, to hot-melt extrusions, and a number of others,” said Patel.
As these R&D projects progress, get filed, and are eventually approved, the commercial revenue is driven.
“The client mix is diverse. It spans clinical and commercial, and the facility’s capabilities span both as well. I’d say that the near-term growth of the number of customers and the number of projects that we’re working on in Quakertown tends to start at the clinical phase and then evolve over time and transition towards commercial,” said Patel.
Capsugel’s technology enables high-potency micronization with containment.
What Does this Mean for the Quakertown Facility Expansion?
“The overall facility, the buildings themselves, has existed as part of Powdersize prior to Capsugel’s acquisition and post. The announcement is largely around the expansion of capabilities and capacities within those existing facilities,” Patel explained.
The underlying expansion is based around jet-milling technology, a technology that Powdersize is a specialist in.
Using compressed air to create high velocity within a piece of equipment, jet milling grinds particles into smaller particles in order to achieve specific sizes and other characteristics.
“The [jet-milling] technology that exists at Powdersize is very custom,” said Patel. “It has a number of different proprietary characteristics and processes around it.”
The expansion will also focus on introducing new pilot suites specifically for programs in the developmental phases.
“As we bring additional pilot suites online, it also gives us the flexibility to take existing commercial-scale capacity and upgrade that to support what we think is going to be significant growth in our overall services,” said Patel.
In addition to expanding the amount and type of equipment used at the Quakertown facility, Capsugel will also be addressing improvements to the following:
- How the equipment is set up
- How exposures affect operators
- How to more efficiently clean the equipment
- How to best contain highly-potent materials and ingredients
“As those adjacent improvements are implemented, at the end of the day, it should allow us to improve turnaround time for customers as well as make sure that we’re implementing the best working environment for our colleagues,” said Patel.
Servicing more than 4,000 customers, Capsugel’s expansion within the walls of its Quakertown facility has the potential to impact not only current and future pharmaceutical customers, but the Capsugel colleagues and, ultimately, patients.
Lead image caption: Micronizing developmental quantities of API.
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