ProJect Pharmaceutics expands its service portfolio to meet customer’s increasing need for the development of dedicated formulations stabilizing above ultra-cold storage conditions for viral therapeutics such as GMOs, ATMPs and VLPs, and vaccines.
ProJect Pharmaceutics expands its service portfolio to meet customer’s increasing need for the rational, science-based development of stable formulations above ultra-cold storage conditions to facilitate handling, supply chain, distribution and storage, not only for protective and therapeutic vaccines, but also for viral therapeutics, GMOs, VLPs, ATMPs, as well as gene and cell therapy (GCT) products such as adenovirus, adeno-associated virus (AAV), and lentivirus.
New, expanded safety facilities in dedicated labs and a deep understanding of the challenges when processing live virus and vaccine products enable ProJect Pharmaceutics to provide specific solutions for this group of highly complex products:
- Cell and gene therapy product formulation and lyophilization (adenovirus formulation and adenovirus lyophilization, AAV formulation and AAV lyophilization, lentivirus formulation and lentivirus lyophilization)
- Virus formulation and virus lyophilization / virus vector formulation and virus vector lyophilization
- Virus freeze thaw studies as pre-requisite for virus freeze drying
- Aggregation tendency screening (full factorial DoE formulation design)
- Formulations for advanced therapy medicinal products and ATMP lyophilization
- Vaccine formulation and vaccine lyophilization
- Virus-like particle formulation and virus-like particle lyophilization
- Bacteriophage formulation and bacteriophage lyophilization
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.
Virus protection: Maintaining the native quaternary structure of the virus capsid and avoiding virus aggregation is the key to maintain its full biological activity and viral potency even under stress conditions like elevated temperature, freezing or virus freeze-drying.
Cutting-edge analytical high-throughput methods (e.g. DLS, NTA) have been implemented in our biological safety lab in order to select the most effective combination of excipients for the final drug product.
Our biosafety lab is equipped with a dedicated pilot freeze dryer to design tailored lyophilization cycles both maximally robust and efficient in order to maintain virus activity during long term storage.
Graphic courtesy of Hic et nunc (CC BY-SA 2.0 DE).