Due to increasingly targeted treatments of sometimes very specific diseases, therapeutics are becoming effective in ever smaller doses on the one hand and are being used in personalized medicine and the treatment of rare diseases on the other.
This creates challenges in plant design: 1. Smaller batch sizes up to batch size 1 2. Highly potent active ingredients with high requirements for employee protection 3. New methods, such as cell and gene therapeutics In aseptic production processes, small batch sizes can be accommodated with multi-purpose plants. These can fill various ready-to-use (pre-sterilized) materials such as syringes, vials, and cartridges. We have already planned, commissioned, and qualified such a multi-purpose plant for our customer swissfillon. The focus was on product safety, optimum plant availability and current and future GMP requirements.
In the production of active ingredients, both mono-product and multi-product plants can be used, with very high requirements for employee protection. In both cases, it is necessary to decipher the process precisely with regard to the risks for employees and the environment. These are evaluated in a risk analysis and appropriate measures are developed to reduce the risk. We can support you both in the risk analyses and in the planning of appropriate containment measures.
With the further personalization in the treatment of patients, procedures from cell and gene therapy are increasingly coming onto the market. For a fast market entry, it is crucial to efficiently scale up the concepts developed on a laboratory scale to a larger production scale. Here, too, the process is in the foreground and with a process simulation we can make a significant contribution to optimizing investment decisions with calculations of capacities, cycle times, etc.
We can support you in all phases of the three areas of plant design, from conceptual design and engineering to process validation.
- Planning of a new, ultra-modern and aseptic fill & finish plant, swissfillon AG, Visp (CH)
- Planning and execution of a multi-purpose plant for API, Lonza AG, Visp (CH)
- Planning of a new filling plant, armasuisse Immobilien, Münchenbuchsee (CH)
- Planning, conversion and expansion technical center/purification, CordenPharma Switzerland LLC, Liestal (CH)