The start-up enter­prise PurelMS not only develops dry powder inhalers (DPIs) but also pro­duces them in their own GMP com­pliant clean­room. All prod­ucts are based on the Cyclops™ plat­form and are also char­ac­ter­ized by another common fea­ture: “The ’pure‘ in our com­pany name means that we use as few excip­i­ents as pos­sible in our for­mu­la­tions,” says Floris Gras­meijer, Prin­cipal Sci­en­tist at PureIMS. “The spe­cial dis­persing tech­nology of our plat­form makes this pos­sible without affecting drug effi­cacy. In most cases, we only need a small per­centage of an excip­ient for our for­mu­la­tions, in some cases we require none at all. This is ideal for high-dose applications.”

How­ever, this spe­cial­iza­tion also poses par­tic­ular chal­lenges: “Com­mer­cially avail­able for­mu­la­tions con­tain up to 95% lac­tose. This is what makes the powder flow­able and enables repro­ducible dosing,” explains Gras­meijer. Pure for­mu­la­tions, on the other hand, have poor flow prop­er­ties. Con­ven­tional filling tech­niques are there­fore often not suit­able for such powders.

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Ani­mated demon­stra­tion of the Cyclops™ dry powder inhaler:

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Looking for options to scale and automate

“At the begin­ning, the entire powder filling process was done man­u­ally. The repro­ducible dosing of our cohe­sive for­mu­la­tions was not a topic at that time,” recalls Floris Gras­meijer. “Of course, the whole thing was very time con­suming – and we rather wanted to spend our lim­ited resources on devel­op­ment. So, we were looking for options to scale and auto­mate the process. Already at that time we had good con­tacts with Harro Höfliger and thus came across the Omnidose dosing machine with drum filler technology.”

Numerous filling tests

The tran­si­tion from manual dosing to the semi-auto­matic filling process was tricky: “The drum filler of the Omnidose forms the powder into small pel­lets and our inhaler plat­form was not yet adapted to this process,” explains Gras­meijer. “This is why we car­ried out numerous filling tests in Harro Höfliger‘s clean­rooms. With the sup­port of the experts on site, we were able to adapt our inhalers in such a way that it became pos­sible to process the pel­lets. Today we have our own Omnidose, which is a real eye-catcher in our cleanroom.”

“The drum filler of the Omnidose forms the powder into small pel­lets and our inhaler plat­form was not yet adapted to this process.”Floris Gras­meijer, Prin­cipal Sci­en­tist at PureIMS

Into the grown-up world

These exten­sive tests have paid off: “We now spend much less time on pro­duc­tion and can focus more on devel­op­ment and the search for part­ners to finance the later devel­op­ment phases of our DPI prod­ucts. The scal­a­bility of dosing processes and of course the well-estab­lished name Harro Höfliger have proven to be major advan­tages in dis­cus­sions with poten­tial partners.”

PureIMS has big plans for the future: “We are still a small bio­phar­ma­ceu­tical com­pany. But things may change very quickly. We have the right prod­ucts, are con­tin­u­ously expanding our process knowl­edge in the field of drug devel­op­ment and also have the appro­priate pro­duc­tion equip­ment. So we are making our way into the grown-up world – even if we will never behave like them,” says Floris Gras­meijer, tongue in cheek. “And when we get there, we will of course remember the push in the right direc­tion which Harro Höfliger once gave us.”

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Photos: PureIMS