Intertek partners with CrystecPharma to advance formulation science and accelerate development timelines for dry powder inhaler products

Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce that it has entered a partnership with CrystecPharma, focusing on advancing formulation science and accelerating development timelines for inhaled medicines, particularly dry powder inhaler (DPI) products.

Initially developed for asthma and chronic obstructive pulmonary disease, DPIs provide direct drug delivery to the lungs, enabling rapid action and lower doses than more conventional oral administration. As well as other respiratory diseases, DPIs are now being explored for other applications including treatment of bacterial lung infections, delivery of vaccines, and systemic drugs like insulin.

For over 30 years, Intertek has actively contributed to the future of orally inhaled and nasal drug products through its Centre of Excellence for the development of these medicines at its Cambridge, UK, campus.

CrystecPharma is a crystal and particle engineering company which applies its proprietary ‘mSAS®’ (modified Supercritical Anti-Solvent) drug formulation technology to improve the performance of medicines. The technique allows many molecules that are traditionally challenging to formulate as powders to be developed in this way. CrystecPharma also has a unique set-up that means formulation and process development can occur in a matter of weeks.

The two companies will develop a “fast to clinic” platform to support pharmaceutical clients with rapid DPI development, from the initial formulation concept to GMP clinical manufacturing, in less than half the time typically required. This highly agile, rapid framework will allow clients aiming to formulate small or large (biologics) molecules, or to repurpose existing active pharmaceutical ingredients, to benefit from technology which enables new forms of molecules to be crystallised and novel particles to be manufactured in ways that greatly enhance their therapeutic performance.

Chris Vernall, Intertek Commercial Director, said: “Combining the proprietary mSAS® 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.’’

Paul Thorning, co-founder and Chief Executive Officer of CrystecPharma, shared: “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.”

The platform, available from January 2025, is underpinned by Intertek’s deep experience in developing robust analytical methods for inhaled drug product quality, expertise in device selection and performance testing, and flexible approach to scalable GMP clinical manufacturing.