Conventional pharmaceutical manufacturing is characterized by validated process steps and extensive lab testing procedures. Although their main focus is human health, pharmaceutical companies today need to look into systematic cost savings.
The FDA PAT-Guidance recommends to use of potential for improving pharmaceutical development, manufacturing, and quality assurance through innovation in product and process development, process analysis and process control. PAT is a risk-based strategy for designing, analyzing and controlling manufacturing processes. Process understanding based on PAT intrinsically results in safety of patients and regulatory compliance.
Sartorius provides you with tailored PAT solutions that ensure product quality, cost savings and documentation.
NIR spectroscopy can be used to monitor cell parameters such as viability. Moreover, the whole bioprocess can be monitored and compared to a golden batch by means of process trajectories.
This helps saving batches as the information of changes within the process is available in real-time and does not rely on sampling procedures any more.
When special raw materials are weighed in, all steps performed according to formulation instructions must be recorded with
the highest accuracy and transparency as required by the FDA and by GAMP.
ProMix Recipe Management System for 100% Traceability
Design of Experiment (DoE) is often used to improve productivity and increase understanding of bioprocesses. The versatility of the BIOSTAT® Qplus multi-bioreactor system supports the requirements for the execution of parallel and automated DoE investigations. By fusing DoE capabilities with the bioprocess management software BioPAT® MFCS/win, Sartorius enables users to explore and identify the best process conditions, while simultaneously minimizing the need for expensive and time-consuming experiments. The report generated by the system shows which optimized parameters will lead to a substantial increase in protein production.
To achieve full traceability of its production process, the Fraunhofer Institute for Molecular Biology and Applied Ecology decided to implement the Sartorius ProMix recipe management system. With this system up and running, recipes can be managed, and all the steps including weighing of the entire process are recorded and well-documented in a 100% traceable, online paper trail that can also be printed. The instruments used (balances and pipettes) are routinely validated for compliance within the required limits.
PAA Laboratories installed a comprehensive CosRewis manufacturing execution system (MES). Engineered and installed by Sartorius together with Klar Partner, the system covers all steps from raw material batching to filling into vials for shipping. Parametric configuration of manufacturing instructions was one major decision factor, reducing tedious and manual steps in the definition of new products for producti
High-tech MES|Biopharmaceutical Formulation System