Thursday, February 27, 2014

Creating a Protein C Biobetter

Yesterday, Biopharmaceutical Development and Production Week speaker Dr. Michiel Ultee shared with us the different between a biosimilar and a biobetter.  This March, he will be addressing how to develop and manufacture an biobetter therapeutic.

Today, he takes an in-depth look at the biobetter he'll be presenting about:

It’s a version of Protein C, an analogue that has some amino acid changes to change the property very slightly, but significantly. Protein C is a protease that was initially marketed by Eli Lilly under the name “Xigris”. It was taken off the market a couple of years ago because of one particular side effect that was difficult – that was induced bleeding in some patients. That’s because it had an efficacy that would inhibit coagulation. It had other properties that were desirable, but that was one that caused some bleeding episodes in some patients being treated for medical conditions such as stroke.

ZZ Biotech, the company that Gallus has worked with on this project, developed a new form that was re-engineered where three amino acids have been changed so that this former Protein C no longer has the ability to inhibit blood coagulation. Therefore, it does not affect bleeding that was seen before. But it retains the cytoprotective qualities of the Protein C, allowing it to be an effective therapy for stroke victims and other disease states.

So, it’s really a biobetter because it’s an improved or second generation version of the first drug, but based on the same general protein, in this case Protein C – that enzyme.

Listen to Dr. Ultee's podcast and other insights from the speakers of BDP Week here.

Dr. Ultee will be presenting the case study A New Biobetter Therapeutic – Development and Manufacturing: A Collaboration Case Study with Kent E. Pryor, Ph.D., Chief Operating Officer, ZZ Biotech at BDP Week.  For more information on this session and the rest of the program, download the agenda.  If you'd like Mike this March 24-27, 2014 in San Diego, as a reader of this blog when you register to join us and mention code BDP14BLOG, you'll save 20% off the standard rate!

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