Issue link: https://www.e-digitaleditions.com/i/648486
also bought Irix, which specializes in APIs for high-potency drug products. Those acquisitions, coupled with other internal initia- tives, prompted Patheon's "OneSource" campaign, which promotes the company as a single-source solutions provider, from API to commer- cial production, said Kaspar van den Dries, Patheon's senior director of formulation sci- ences for solid dose and soft- gels. He said the end-to-end capability includes "supplying the API and drug product from the early phase to late phase, and doing all the work around that, including the compliance, where we have a good his- tory. It is quite unique in the industry." Customers include Big Pharma companies that are cut- ting back in some areas of development, and small and emerging companies. "Many times they are virtually based and while they certainly have the clinical or medical exper- tise, they don't necessarily have the infrastructure, supply chain, and logistics to support CMC development," van den Dries said. "For this reason, we see a very broad range of companies who are interested in these services." Naturally, not every client or project needs every service, especially in early development. "Some want to establish proof-of-concept and spend as little money as possible on the upfront formulation work, so they choose fit-for-pur- pose formulations just to make it work," he said. Other companies, mostly midsize and bigger pharma companies, usually take a more comprehensive approach to eliminate the need for pharmacokinetics bridging studies and a new formulation in a later stage of clinical development. "We also see companies that want to have a bona fides formula- tion developed that starts from a tablet or a capsule from phase 1 onward." Rottendorf is a German company dedicated to solid dosage forms. In March 2011, it formed a US corporation led by Gordon Haines, but manufacturing and packaging remains in Germany and France. "Because we have a pres- ence in the US that manages the time difference, the physi- cal distance is much less a barrier than it would've been 10 years ago," Haines said. "We're not finding that to be an insurmountable barrier whatsoever." Indeed the US market, which accounted for less than 5 percent of the company's total revenue in 2011, now represents more than 20 percent of total revenue. The company's development group employs more than 40 scientists, all of whom work on a broad range of solid oral dose products. "That's all we do, because that's our area of expertise, hard-core solid dose technologies," Haines said. The company manufactures about 600 different SKUs annually, including multilayer tablets, fixed-dose combina- tions, as well as timed-release, controlled-release, and tablet-in-tablet products. "It's across the board and across multiple therapeutic areas, even OTC products." As for new technology, Haines said Rottendorf takes a "5- to 10-year look" to see what it should explore and the company may begin making high-potency products. It's also working with Bosch on micro-dosing technology and with a consortium of universities and companies evaluating nano-dosing. "We want to ensure that we're offering the technologies that the solid oral dose world is looking for and will be looking for. That's driven by our customers and we will expand into the new technology that works for them," Haines said. Rottendorf recently bought more land near its headquarters to accommodate an expan- sion. It might also build in the USA. "Our long-term vision is to have, at a minimum, packaging operations here, and potentially offering manufacturing. It'll be driven by the business," Haines said. And business has been good. "Our focus in the USA when we started was midsize, smaller, and virtual companies that could use a full range of our services. But Big Pharma has found us, so it's really been across the board." CDMOs become "technology-agnostic" experts According to Patel, "There's an increasing desire for the pharmaceutical companies to tap the best expertise possi- ble, and outsourcing is one of the best ways to do that." He said that 10 years ago, there was some question about the future success of the outsourcing model, but the recession of 2008 led to a lot of downsizing at Big Pharma and prompted companies to seek more partnerships, which led to successful launches. "That's given the entire industry much more confidence to collaborate on unique technolo- gies and unique capabilities. Those are two of the growth drivers in the CDMO market." While Capsugel offers a variety proprietary technolo- gies, it doesn't insist that customers use them. "Our goal is to be flexible and adaptable enough to align with the cus- tomer to do what makes sense from a science-driven per- spective," Patel said. "Technologies by themselves are just a means to an end to solve problems. The most important statement I would make of Capsugel and DFS is that our strategy and our business model are built around being 12 March 2016 Tablets & Capsules Capsugel's acquisition of Xcelience increased the its solid dosage formu- lation and manufacturing capabilities, including microdosing in capsules, clinical supplies and services, and tabletting. The photo shows a Fette P1200i tablet press in operation at the company's cGMP production facil- ity in Tampa, FL. Photo courtesy of Capsugel Bioavailability enhancement, modified-release capabilities, and high-potency handling are among the areas of new investment.