Increasing production costs and competition from lower cost economies make it increasingly difficult for Pharma companies in Europe to manufacture cost effective products. The trend is for European Pharma manufacturers to disinvest in Europe and set up production facilities in lower cost countries. While still being a leading industry, key production equipment suppliers have suffered job losses (and bankruptcy) over recent years. The emphasis in European Pharma is therefore on reducing production costs and investing in more-effective, more-responsive, and innovative manufacturing technologies.
One such early trend is the innovative Continuous Manufacturing (CM) in place of traditional Batch Manufacturing. 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, and it is now beginning to be applied in Pharma 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 in a carrier, containing meltable materials and additional (inactive) excipients. As pharmaceuticals become more sophisticated with a higher specificity and less side effects, their solubility and therefore their bioavailability suffers. 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 will be greatly aided by the better availability of inline monitoring tools: The technological basis for CM is the use of Process Analytical Technology (PAT), a mechanism to design, analyse, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters which affect Critical Quality Attributes (CQA). Previously, it was virtually impossible to determine the clinical efficacy of an API online. This made the control and optimization of processes more difficult, as laboratory tests usually take a long time. 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 the manufacturers understanding and control of the process, increase process quality, and reduce the risk of losing products due to nonconformity. Moreover this approach aligns with the EU strategy to attain a leadership position in the “Industry 4.0” as IMPAX will enable a data-driven pharma manufacturing, contributing to seizing Europe´s chance to assume a leader role in tomorrow´s digital economy.
The overall objectives of IMPAX are:
1. Contributing to the uptake of the HME/WG in the Pharma industry by engineering the multi-spectra platform
2. Demonstrating quality and bankability of the IMPAX platform through validation with Pharma End-users
3. Introducing the platform in the Pharma market.
