Integrated development process
Iconovo has an integrated development process where the various functions are fully integrated and internal.
Development of the inhaler, formulation and characterization is carried out in close collaboration between the three functions.
An integrated development process of the inhaler and formulation is crucial for a successful development of an inhalation product and reduces lead times, costs and risk.
At Iconovo we have invested in our own laboratories equipped with specialized equipment for the development of inhalation products;
Working to international standards and guidance is of utmost importance in the pharmaceutical industry. Iconovo’s quality system complies with the current version of ISO 13485 (standard for medical devices), and FDA’s Quality System Regulation, 21 CFR Part 820.
Iconovo’s combination product development is performed in accordance with FDA’s requirements (21 CFR 4) and to EMA’s, FDA’s and ICH guidelines for Combination Products.
Yes. Iconovo has significant expertise in developing generic inhaler products that can match an originator product. It is very challenging to meet the regulatory equivalence standards for an inhalation product, but Iconovo has the experience to pull it off. See our collaborations for currently on-going developments of generic products.
Yes. Iconovo has four different inhaler platforms to choose from depending on your preferred inhaler solution. Iconovo can run the complete project, you deliver your API to us and we deliver back a working inhalation product of your choice.
Making peptides into a functional inhalation powder requires special technologies to make the inhalation powder, spray-dried particles or engineered particles. Iconovo does not currently have this formulation technology in-house but have collaboration partners with this expertise. Iconovo has good experience in delivering spray-dried formulation to the lung using ICOone. ICOone offers good lung delivery properties as well as the ability to protect the dose from humidity and to deliver large doses to the lung.
Iconovo develops powder formulations for inhalers from Iconovo only. Iconovo is not a contract development organization that works for strict fee-for-service agreements.
ICOcap™ can be purchased off the shelf from our collaboration partner Stevanato that manufactures, distributes and sells ICOcap. ICOcap is a stand-alone capsule inhaler that is loaded with separate capsules with inhalation powder. The other inhaler platforms of Iconovo are integrated products consisting of inhaler and pre-loaded inhalation powder. Thus, each new product is a development project where the inhaler and the inhalation powder have to be optimized together. Iconovo provides this optimization service but it means that these inhalers cannot be purchased off-the-shelf.
ICOcap™ is the only inhaler from Iconovo that can be purchased off the shelf. ICOcap is manufactured, distributed and sold by Stevanato, a collaboration partner of Iconovo. Stevanato can offer you supply prices at your request. Either contact Stevanato directly or send a question to Iconovo and we can connect you.