Intertek and CrystecPharma Partner to Advance Formulation and Development of Dry Powder Inhaler Products

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Intertek, a total quality assurance provider, announced on Dec 11, 2024 that it has entered into a partnership with CrystecPharma, a UK-headquartered crystal and particle engineering company that applies proprietary modified supercritical fluid (SCF) technologies to improve drug performance, in which the companies will focus on advancing formulation science and accelerating development timelines for inhaled medicines, specifically dry powder inhaler (DPI) products.

Under the agreement, the companies will develop a “fast to clinic” platform that supports pharmaceutical clients by providing rapid DPI development—from the initial formulation concept to good manufacturing practice (GMP) clinical manufacturing. The companies are aiming to accelerate DPI development to less than half the time typically required. The agile, rapid framework will be designed to allow clients, who are looking to formulate small or large (biologics) molecules, or who are looking to repurpose existing APIs, to benefit from technology that enables crystallization of new forms of molecules. Clients will also have access to technology that allows for the manufacture of novel particles in ways that significantly enhance those particles’ therapeutic performance, according to a company press release.

“Combining the proprietary mSAS [modified supercritical anti-solvent] technology and the speed of early development that partnering with CrystecPharma affords, with the GMP manufacturing and analytics expertise at Intertek, provides the market with an unparalleled service in this area. This unique platform will enable highly effective, stable, and safe DPI medicines to be developed and brought to market in a fraction of the time previously possible,” said Chris Vernall, commercial director, Intertek, in the press release (1).

CrystecPharma’s proprietary drug formulation technology, mSAS, aims to improve the performance of therapeutics by using a supercritical fluid—typically carbon dioxide because of its low critical point conditions and attractive physical properties—to remove solvent rapidly from a drug solution. This rapid solvent removal allows the drug to precipitate as dry particles. SAS has many advantages, particularly its ability to crystallize drug molecules and remove solvent in a way that only parts per million is left behind in the final product. However, conventional approaches to using SAS have limitations. For instance, these processes are often unstable, difficult to scale, and the nozzles used are prone to blockage, according to CrystecPharma (2).

CrystecPharma’s technique allows many molecules that are traditionally challenging to formulate as powders to be developed in that format. The company also has a unique set-up that enables formulation and process development to occur in a matter of weeks, according to the company press release (1).

“The strength of our award-winning mSAS technology and Intertek’s expertise in analytical development and GMP clinical manufacturing creates unique opportunities to develop innovative, high-performing medicines and improved treatments for patients,” said Paul Thorning, co-founder and CEO of CrystecPharma, in the release (1).

The platform that Intertek and CrystecPharma are collaborating on will be made available starting in January 2025.

DPIs were initially developed for treating asthma and chronic obstructive pulmonary disease by delivering the therapeutic directly to the lungs. This direct-to-tissue delivery enables rapid action and lower doses than more conventional oral administration. In addition to other respiratory diseases, researchers are now exploring DPIs for other applications, including treatment of bacterial lung infections, delivery of vaccines, and systemic drugs such as insulin.

References

1. Intertek. Intertek Partners with CrystecPharma to Advance Formulation Science and Accelerate Development Timelines for Dry Powder Inhaler Products. Press Release. Dec. 11, 2024.
2. CrystecPharma. mSAS Technology. crystecpharma.com (accessed Dec. 12, 2024).