Cellular and tissue based products CDMO for the Japanese market
To expand the availability of safe and effective cell and tissue therapies, we design, implement and operate cell processing facilities for the manufacture of cellular and tissue based products.
Our product development experts deliver comprehensive pharmaceutical development and application support at every stage, anticipating and responding to regulatory trends, while planning strategic development and carrying out research and surveys.
At our regulatory-compliant cell processing center we perform contract manufacturing of cellular and tissue based products, covering all stages from collection of starting material to manufacturing and safety testing, supported by our team of cellular specialists.
At each stage of the cell based medicine manufacturing process, we fulfill the requisite biological, safety and pharmacological efficacy assessments. These comprise sterility, endotoxin, mycoplasma and viral/microbial testing.
We offer decontamination products developed in-house: Fogact assures reliable, safe decontamination of inside of laboratory equipment. PBio is formulated specifically for clean room administration.
Our product development experts deliver comprehensive pharmaceutical strategic development consultation, research and surveys.
We prepare documentation and applications in accordance with Japanese regulatory trends to facilitate product approval.