Companies in the emerging nations like India were the front runners in the Biosimilar development in terms of small protein molecule development over the last decade. I being a molecular biologist was working on E.coli and Yeast and and i could say cloning of small molecule is much more simple work compared to complex molecules rituximab and infliximab and now the third wave which are one step more complex to develop and produce.
The issues companies in India are facing is that pilot scale production for the mAb sometime cannot be copied the same way in large scale production cycle with various factors taken into consideration, and the complexity in production increases when you move from bacteria, yeast to cell lines, then the per batch yield is also a big hurdle, also the regulatory issues related to the upstream and downstream production in regulated market such as EU and US, thus these companies are first launching their product in semi regulated and non regulated market and then looking for partners or collaborators to design PIII trials in regulated market and further launches
The article which i was reading today they mentioned that companies need to understand the MOA of cell lines, Sometime after understanding how the cell line behaves companies still face issues related to per batch production yield.
And i believe that the approval for the second and third wave of Biosimilars is still going to be difficult as regulators are still developing their understanding of the complexity of these molecules and further their safety and efficacy.
The issues companies in India are facing is that pilot scale production for the mAb sometime cannot be copied the same way in large scale production cycle with various factors taken into consideration, and the complexity in production increases when you move from bacteria, yeast to cell lines, then the per batch yield is also a big hurdle, also the regulatory issues related to the upstream and downstream production in regulated market such as EU and US, thus these companies are first launching their product in semi regulated and non regulated market and then looking for partners or collaborators to design PIII trials in regulated market and further launches
The article which i was reading today they mentioned that companies need to understand the MOA of cell lines, Sometime after understanding how the cell line behaves companies still face issues related to per batch production yield.
And i believe that the approval for the second and third wave of Biosimilars is still going to be difficult as regulators are still developing their understanding of the complexity of these molecules and further their safety and efficacy.
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