Formulation and lyophilization process development for live virus vaccines

ProJect Pharmaceutics expands its service portfolio to meet customer’s increasing need for the development of GMO S2 and BSL-2 biological products including live viruses.

ProJect Pharmaceutics is one of the leading European service providers offering tailored pharmaceutical formulations and lyophilisation processes for therapeutic proteins, peptides and other therapeutic compounds.

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. Customers will benefit from safer products with an optimized stability profile and reduced manufacturing costs.

For more information please visit: www.project-pharmaceutics.com or contact:
ProJect Pharmaceutics GmbH
Fraunhoferstraße 22
D-82152 Martinsried
+49 (0) 89 452289700