Introduction to Impax

IMPAX will extend and enhance our spectroscopy platform to specifically suit the needs of the pharmaceutical industry. A range of other applications that require deeper knowledge of manufacturing process controls and parameters will also be addressable, leading to improved output quality and consistency. Increased use of continuous manufacturing (CM) methods has set the spotlight on the lack of suitable and reliable ways to directly monitor process outputs in a way that can quickly and reliably detect deviations. ColVisTec has, for a number of years, supplied in-line UV-VIS spectroscopy systems that are specially designed for demanding manufacturing processes. Through IMPAX, we now build on this knowledge to extend this technology portfolio further. Our new instruments will include bespoke software and other supporting features that are necessary to meet the special demands of the pharmaceutical industry. IMPAX is supported by the Horizon 2020 SME Instrument programme of the European Union. Extruder based production is currently one of the most widely used CM techniques within plastics manufacturing and it is extensively applied in the food processing industry. Extruder based production is now beginning to be applied in pharmaceutical manufacturing for a wide variety of dosage forms and formulations, including: granules, pellets, tablets, capsules, implants, transdermal systems and ophthalmic inserts. Active pharmaceutical ingredients (APIs) are embedded within a carrier, containing meltable materials and additional (inactive) excipients. The pharmaceutical industry is facing the ongoing challenge of maximising bioavailability for an increasing number of poorly-soluble drug compounds. CM extruder processes such as Hot Melt Extrusion (HME) and Wet Granulation (WG) significantly outperform current conventional methodology in offering the possibility of forming solid dispersions with improved bioavailability.
The implementation of HME/WG would be greatly aided by the better availability of in-line monitoring tools: The technological basis for CM is the use of Process Analytical Technology (PAT), a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters that affect Critical Quality Attributes (CQA).

It has in the past been a real challenge to determine the clinical efficacy of an API online, i.e. during a manufacture process. This made the control and optimization of processes more difficult, as laboratory tests usually take a long time to perform. PAT closes this information gap as data is collected directly in the process in real-time and allows instant corrections and automation. Tools for analysis improve manufacturers’ understanding and control of their processes, increase product quality and reduce the risk of losing products due to nonconformity. Moreover, our approach aligns with the EU strategy to establish a leadership position in “Industry 4.0”, as the novel IMPAX platform will enable data-driven pharmaceutical manufacturing, driving forward Europe´s bid to assume a leading role in tomorrow´s digital economy.
PAT has been defined by the FDA as a mechanism to design, analyse and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters which affect CQA. The creation of a fully integrated CM process for Pharma will require advanced, reliable PAT. Without such data, the CM proposal cannot achieve its full potential. This is the basis for the IMPAX development of systems specifically tailored to the Pharma industry.

The Executive Agency for Small and Medium- sized Enterprises (EASME) under the power delegated by EUROPEAN COMMISSION (Horizon2020) helps small- and medium-sized enterprises (SMEs) bringing their new products to the market faster. The aim is to promote growth, employment and export, particularly for SMEs, because this group of enterprises will create the major part of future innovations.

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