Merck: new production line in Bari for injectable drugs in syringes

A new production line for injectable drugs in syringes has arrived at the Merck-Serono plant in Modugno, on the outskirts of Bari. The line is being built with an investment of around 56 million euros and uses 'in isolator' technology, a reference production model in the sector that allows strict sterile conditions (the operator has no contact) for the preparation of injectable drugs in syringes. The project - developed in collaboration with the University of Bari and its spin-off Biofordrug (a 10% owned subsidiary) - is part of a broader investment plan, launched in 2015, of 228 million euros, co-financed for 10 by the Puglia region, for the complete renovation of the Modugno production site of the multinational company present in 65 countries, and generating a turnover of 21.2 billion euros in 2024.

The approach that characterises the entire plan is based on the concept of 'Quality by Design', in which the quality of the finished product has guided the design of processes and machines from the earliest stages. The Modugno site was one of the first of Merck's sites to be equipped with the isolator production technology, as early as 2021, in parallel with the implementation of a new production line for injectable drugs in cartridges, anticipating the indications of the regulatory authorities on the subject of strengthening the safety requirements, and control, of processes for the production of injectable drugs. The experience gained over the last five years has thus made the Modugno site a model of excellence for the aseptic filling of injectable drugs with the highest standards of product quality and operator safety.

A multi-disciplinary public-private research team worked on the transition to the new technology underpinning the 'in isolator' lines under construction. The research work enabled the creation of a new, more flexible production line, thanks to the use of single-use systems that make the handling of particularly potent drug substances safer. Alongside this, product safety has been improved through the analysis of any degradation substances that might be formed with the introduction of the new technologies, and the level of attention paid to the control of the most delicate steps in the production process and to checking that bio-decontamination procedures are always effective and repeatable over time has increased.

'The results obtained from the experimental development project,' explains Annalisa Calvano, plant manager of the Modugno plant, 'will help us validate the new production processes in isolator for the new syringe line, thus guaranteeing the highest standards of product quality and operator safety.