Expansions to meet safety requirements for GMO S2 and BSL-2 biological products.
ProJect Pharmaceutics (PJP), specialists in formulation and process development for parenteral drug products, has extended its safety facilities in laboratories dedicated to handling GMO S2 and BSL-2 based biological products, such as live virus vaccines, protective and therapeutic vaccines, as well as gene and cell therapy products.
The GMO S2 and BSL-2 safety lab is equipped with a dedicated pilot freeze dryer to design tailored lyophilization cycles that are both maximally robust and efficient. Cutting-edge analytical high-throughput methods have also been implemented to select the most effective combination of excipients for the final drug product to maintain the active quaternary structure of a virus capsid and avoiding aggregation, even under stress conditions such as elevated temperature, freezing and freeze drying.
The company’s extensive experience and deep understanding of the challenges when processing biotherapeutics enables it to provide smart formulations and manufacturing processes for virus vaccines or other classified drug products in their dedicated labs that fulfil the mandatory safety requirements up to GMO S2 and BSL-2 classification. Customers will benefit from safer products with an optimized stability profile and reduced manufacturing costs.Read More