Coriolis expands ATMP facilities to advance formulation
The re-construction of an existing building on the site began in March of this year and will be operational by the fourth quarter of 2021.
A spokesperson for the company told BioPharma-Reporter that the overall cost of the project would reach approximately €5m (US$5.9m).
The company noted that the number of ATMP products in development and the overall growth experienced in this industry segment was the rationale behind the expansion. Coriolis said that since 2018 it has been expanding its scientific expertise and range of services in the area.
Lyophilization development center
As well as providing formulation development for ATMPS, the new lab space will conduct cell culture activities, particle characterization and identification, analytical ultracentrifugation and host a lyophilization development center for ATMPs. Once complete, the expansion will allow ATMP formulation development up to biosafety level S2.
On announcing the news, Coriolis stated that current ATMP formulations are ‘still far from advanced’. The company’s spokesperson added further detail to this, outlining: “The situation with AMTPs (i.e. viral vectors but also cell therapy products) is similar as in the first years when protein therapeutics had been developed for human application: it took years until formulation sciences [for protein therapeutics] developed to the current status.”
The spokesperson explained that this progression occurred with protein therapeutics through analysis of pH, ionic strength, and excipient combinations, alongside identifying suitable stability indications methods to understand degradation pathways. In turn, the company expects to utilize its own experience in this area to aid the development of ATMPs.
One drawback of certain current ATMPs is either their short shelf life, which can range from hours to days, or their cold storage requirements.
A solution to this that Coriolis is exploring is to use lyophilization to improve the shelf life of ATMPs, which involves the removal of water to slow down hydrolysis or other chemical changes to reduce interaction between different molecules.
“However, lyophilization can only be successful if both the formulation composition (suitable excipients) and the lyophilization process parameters are well selected and developed for the respective API. It is key that process understanding and formulation science are combined to achieve a stable product,” the spokesperson added.