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Biotech / Medical : Coherus BioSciences: Pure Play In The Emerging Biosimilar In
CHRS 1.690-0.3%2:32 PM EDT
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To: DewDiligence_on_SI who wrote (1)1/12/2015 3:23:49 PM
From: Arthur Radley   of 9
 
That number of Phase III programs does seem like a tall mountain to climb, but reviewing information on their website it appears that they can move quickly into trials with their analytic system. My guess is that all of this will depend on the pending Phase III results expected by mid-year. They certainly will need partners or the need for raising money by secondary offerings will come into play---quickly!

"Once several lots of the innovator molecule have been analyzed, a process must be designed to produce a molecule that falls within the variability of the reference product lots. With our precise process science capabilities, we have consistently demonstrated in-vivo and in-vitro biosimilarity and pharmacokinetic bioequivalence.

With proprietary technology, we produce stable cell lines that will make the same protein sequence as the innovator. As many of our products are glycosylated proteins, we must define a cell culture process that will yield a product with the right glycan profiles. And, it must match other important post-translational modifications. A purification process must also be developed that will yield a high quality product. Through these processes, we have reduced traditional cell line development time from 24 months to about six weeks as well as increased expression more than 20 fold without any change in the scale-up process.
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