To be constructed
At OranssiBio, our exosome platform has the following features:
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US/EU compliant facility with GMP and other quality requirements;
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Fully integrated services covering process development, analytical method development, GMP manufacturing, quality control and stability testing, as well as CMC regulatory support;
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Scalable and high productive serum-free suspension process with single use bioreactors that deliver a max batch scale at 200L, with productivities up to mid 1014 particles/L;
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Automated and fully closed purification process and fill& finish, ensuring safety and reliability;
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A full suite of analytical methods for in-process controls and finish product release, ensuring highest quality and safety of your product;
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Streamlined operation where pre-qualified raw materials and consumables are in-stock, and pre-qualified equipment are available, to allow a rapid start of your program.
An Illustrated Flowchart for Exosomes
-
US/EU compliant facility with GMP and other quality requirements;
-
Fully integrated services covering process development, analytical method development, GMP manufacturing, quality control and stability testing, as well as CMC regulatory support;
-
Scalable and high productive serum-free suspension process with single use bioreactors that deliver a max batch scale at 200L, with productivities up to mid 1014 particles/L;
-
Automated and fully closed purification process and fill& finish, ensuring safety and reliability;
-
A full suite of analytical methods for in-process controls and finish product release, ensuring highest quality and safety of your product;
-
Streamlined operation where pre-qualified raw materials and consumables are in-stock, and pre-qualified equipment are available, to allow a rapid start of your program.
