Back from Cell Therapy Manufacturing ASIA - Thoughts from our Director of Market Development11 Mar 2020
As a key excipient/raw material supplier, Albumedix monitors advancements, innovation, trends and conversations in the cell therapy manufacturing industry closely. This is why at the end of February, our Director of Market Development and Communication (Poula Maltha Krogh) attended the Cell Therapy Manufacturing ASIA conference in Kyoto.
A number of discussions took place at the conference, one particularly interesting perspective came from Healios KK regarding the Sakigake system (a Japanese regulatory framework that offers an attractive regenerative medicine commercialization path) and its possible effect on manufacturing and CMC.
Several points were made in this regard, including the challenges faced by manufacturing teams concerning raw materials utilized and that they may not be of 'commercial standards' or meet PMDA requirements under this framework. This is especially true of biological media components. As a high-quality raw material/excipient provider this is of course a conversation we are very keen on having both with our customers in Japan as well as with PMDA. This is also why we have secured an ancillary material certificate with PMDA for our recombinant human albumin.
Hearing about all the great work and developments ongoing in Japan specifically, as well as Asia in its entirety in the cell therapies space confirms Albumedix' continuous efforts to engage with current and future customers in this area, to empower the great work they are doing and help these therapies reach patients.