CDMO, Micro-Sphere partners with German machine manufacturer Harro Höfliger for the latest step in its 21 million CHF (€19 million) investment into its facility in Switzerland.
Micro-Sphere, a CDMO specialising in the spray drying of APIs and HPAPIs, noticed a growing interest in using spray drying as a technology for particle engineering in the field of respiratory dry powders. Listening to respected and long-standing clients and keeping abreast of technological advances in the market, the CDMO decided to increase its capabilities, adding new technology to satisfy clients' new needs.
After consulting a number of experts and suppliers, and considering various options, Micro-Sphere concluded their next logical step was to source a technical partner to supply the best available technology to fill spray-dried powder in capsules ‒ the Harro Hofliger Modu-C MS unit.
This capsule filling machine boosts Micro-Sphere’s capsule filling production. A notional production of 72,000 capsules per hour and a 100% net weight check control, grant the correct dose when filling capsules for dry powder inhalers.
Micro-Sphere was satisfied that Harro Höfliger offered the best technology to handle cohesive spray-dried powders for respiratory applications and would be the right partner for the job.
Spray dried powders are sensitive and versatile in terms of physical characteristics and handling needs. The Modu-C Drum dosing technology has the capability to allow for careful powder feeding and precise metering without causing negative impact on final product performance (powder dispersion, stability, etc.) and is therefore the perfect solution for Micro-Sphere's needs.
Adding this capacity has given Micro-Sphere a powerful tool to cover client needs from clinical through to commercial launch.
Micro-Sphere founder and president of the Board, Dr Michele Müller, said: “Low-dose capsule filling is becoming increasingly popular across the market and at present we are the only CDMO in Europe offering this level of capability.
“Harro Höfliger’s powder expertise and technological competence is particularly evident in the Modu-C MS. This investment is an important next step in our expansion plans, allowing us to meet demand for greater capacity and speed up project delivery for our customers.”
Based in Allmersbach, Germany, Harro Höfliger develops and manufactures production and packaging systems and is a valued development partner for many pharmaceutical and medical technology companies.
Marco Laackmann, business unit leader, inhalation at Harro Höfliger added: “The capacitive fill quantity control of the Modu-C MS offers excellent process reliability and is a great choice for Micro-Sphere in line with its continued expansion. We’re delighted to be a part of their exciting future.”
Having been through the process of increasing capsule-filling capabilities, what has Micro-Sphere learnt and what advice can they offer companies in a similar situation?
First, the CDMO would encourage companies to consider collaborative working. "Besides the purchase of a piece of equipment, both companies are technology-driven and service orientated and this has created a positive, winning relationship for both the companies involved and our clients that can have their dry powder inhalers capsules quickly and properly filled under GMP."
It doesn't end with the delivery of the machinery either. Harro Höfliger offers continuous and competent postsale support, and as a result Micro-Sphere is learning how to get the best from the Modu-C-MS unit. Thanks to its clients and Micro-Sphere's spray drying expertise, Harro Höfliger is also learning more about challenges posed by cohesive spray-dried powders.
Micro-Sphere and Harro Höfliger teams are already working together side by side at Micro-Sphere's site to deliver more success stories.Read More