GMP manufacturing of Apta-1 according to plan
Aptahem AB (publ) announce today that the company has signed an agreement with their collaboration partner LGC Group to initiate the GMP (Good Manufacturing Practice) manufacturing of Apta-1. With this agreement, Aptahem ensures that the previously communicated schedule is followed.
By signing this agreement, the GMP campaign starts already in March/April with various preparations running up until the GMP manufacturing process will be initiated in September/October 2021. Delivery of the GMP batch is expected to early 2022. This is an important step in the intense preparations that the company currently are working with to take the lead candidate Apta-1 to clinic in 2022.
CEO Mikael Lindstam comments:
“It is gratifying that we now are able to ensure that the GMP manufacturing will follow the timeplan we have set up. Our contract manufacturer and collaboration partner LGC have in close collaboration with Aptahem now finalized the details for the GMP campaign to ensure the qualities that are mandatory for clinical studies. I am looking forward to continuring our fruitful collaboration with LGC to produce Apta-1 in a large-scale and commercially viable manner.”
For further information:
Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: ml@aptahem.com
About Aptahem
Aptahem AB (APTA) is a biotechnology company that develops aptamer-based pharmaceuticals for the treatment of life-threatening conditions in which a combination of coagulation and inflammation are involved. The company’s primary pharmaceutical candidate, Apta-1, is being developed with the aim of preventing the high mortality rate caused by organ and tissue damage in sepsis patients, among others. The company possesses patent protection in strategic target markets and actively seeks business development opportunities with potential collaborators.