ProJect Pharmaceutics, a German service provider of pharmaceutical formulations and lyophilisation processes for formulation and process development for parenteral drug products, expands its service portfolio with laboratories for handling GMO S2 and BSL-2 biological products such as live virus vaccines, protective and therapeutic vaccines, as well as gene and cell therapy products.
New safety facilities in dedicated labs and a deep understanding of the challenges when processing virus vaccines enable ProJect Pharmaceutics to provide specific solutions for this group of products of high complexity.
Smart formulations and manufacturing processes to safeguard the efficacy of the finished drug product are provided together with mandatory safety requirements up to GMO S2 and BSL-2 classification.
Maintaining the native quaternary structure of the virus capsid and avoiding virus aggregation is the key to maintain its full biological activity even under stress conditions like elevated temperature, freezing and freeze drying. Cutting-edge analytical high-throughput methods have been implemented in our biological safety lab in order to select the most effective combination of excipients for the final drug product.
The GMO S2 and BSL-2 safety lab is equipped with a dedicated pilot freeze dryer to design tailored lyophilisation cycles both maximally robust and efficient. PJP’s long lasting experience and comprehensive know-how of lyophilisation enables our customers to follow new paths in process technology.