Europe optimises drug-making
Generic drugs are playing a bigger role in the world's economies — particularly in Asia — and the EU is working fervently to strengthen its role in this important sector. This requires more efficient manufacturing and processing techniques for bulk active pharmaceutical ingredients (APIs) using faster, energy-efficient continuous processes that produce higher yields and better quality. The EU-funded project 'Innovative multidisciplinary approach to pharma generic production' (PHARMAGEN)(opens in new window) worked to achieve this goal. Keeping in mind that traditional pharmaceutical processes suffer from waste levels of 90 % or more, the project team developed innovative modelling and process control for pharmaceutical manufacturers, merging the advantages of the petrochemical and pharmaceutical industries while avoiding the bottlenecks of both. It showed how continuous processes boast higher quality assurance in the sector. Importantly, the project identified the specifications for three APIs and developed process chemistries for each. It developed the preliminary design of pharmaceutical reactors, assessing API process and control strategies. This led to the filing of one patent and preparation of another. In effect, PHARMAGEN increased know-how about continuous processes for the pharmaceutical sector and boosted high-throughput research by introducing continuous processes. It also helped devise anti-epileptic and anti-diabetic production recipes as well as new control strategies that will help streamline production and offer better pharmaceuticals. Developing effective continuous-processing methods will give European manufacturers a major competitive advantage over Asian producers who have eclipsed Europe's leadership in the APIs market. To illustrate, the project team worked on streamlining production of the HIV drug Ritonavir. It managed to increase production volume by 1 000 times, realising outstanding savings in equipment, utilities, safety measures and emissions containment, as well as 15 % savings in raw material costs. Once this know-how spreads to other key drugs, the price of pharmaceuticals will decrease and the benefits for European manufacturers, such as enhanced competitiveness, will increase.
