ProJect Pharmaceutics (PJP), the German parenteral drug formulation manufacturer, has extended its safety facilities with laboratories dedicated to handle 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 lyophilisation cycles both maximally robust and efficient, the company said.
The company has revealed that 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 like elevated temperature, freezing and freeze drying.
PJP said its long-lasting experience and deep understanding of the challenges when processing bio-therapeutics enables the company 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 optimised stability profile and reduced manufacturing costs,” PJP said in the statement.
Headquartered in Martinsried, Munich's science suburb, ProJect Pharmaceutics offers tailored pharmaceutical formulations and lyophilisation processes for therapeutic proteins, peptides and other therapeutic compounds.