Skyepharma is a specialist CDMO

The global expert CDMO in complex oral solid formulation, development, and manufacturing

For more than 25 years, Skyepharma has been offering its extensive expertise in modified release and oral solid formulation in response to the most demanding technical challenges. The company relies on 3 main pillars to provide the best value to its clients:

  • The combination of a highly skilled scientific team (R&D now represents 25% of the total staff, including 5 PhDs) and a portfolio of proprietary modified and controlled release technologies enables Skyepharma’s partners to benefit from a highly versatile range of solutions in response to delivery or bioavailability obstacles to their development. They can also count on its proven development track record, with a number of successful developments and launches in Europe, the US and Brazil.
  • A state-of-the-art facility based in Lyon, France, which is FDA, EMA and ANVISA approved, offering a robust platform for early-stage, CTM, LCM and commercial activities to Skyepharma’s worldwide partners.
  • A unique culture. We have managed to make our organization and team culture a powerful differentiator. The result is sufficient agility to provide tailor-made solutions, with accelerated scale-up and time to market. And a best-in-class service level, both in terms of on-time delivery and right-first time. This is the cornerstone of the long-term trusting relationship we are building with our clients.

Remaining one step ahead in providing solutions for unmet needs and new-generation drugs

Being a center of excellence in our field also implies continuously adapting our facility and services to changes in product complexity and partners’ needs. Significant investments have been made to keep offering more innovative capabilities and immediate available capacity.

  • API complexity. While Skyepharma has focused in the past on standard small molecules, we are now capable of working on more complex molecules, such a small peptides for the oral route. A major evolution in Skyepharma’s offering is the extension of our services to highly-potent molecules. We have indeed installed a fully dedicated area for OEB4/5 molecules, maintaining a high level of quality and safety, and we have already programmed the addition of further dedicated development and production suites.
  • Controlled release. This is our historical core business. We are continuously reinforcing our team with experts and developing our scientific knowledge in this area. For instance, we have even established an academic partnership with the University of Bordeaux to strengthen our expertise in compression parameters for hard-to-make tablets (tab-in-tab, multi-layer).
  • Skyepharma offers a complete range of solutions to issues such as the reduction of daily intakes for patients to more complex challenges (combination of multiple APIs in modified release formulations, GIT site-specific targeting, pulsatile release, etc.).
  • Bioavailability enhancement. Poor API solubility is one of the main obstacles in the route to market for new developed drugs. Backed by the successful development of a nanoparticle-based tablet that is now on the US market, we are constantly developing our offering in this area (microfluidization, particle-size reduction, nanoemulsion, nanoencapsulation)
  • Small to large volumes. Skyepharma’s agility is also reflected in our capacity to offer a very broad range of batch-sizes. Capable of starting at a few hundred grams (and offering up to a ton or more at commercial scales), we can provide adapted and cost-effective solutions to clients of all sizes, including virtual Pharmas and companies working on rare or orphan diseases.