Please tell us a bit about SCYNEXIS and its IntegratedPharmaceutical Services division, is it new?
SCYNEXIS has integrated offerings of high-end chemistry and biology services with a focus on Integrated Pharmaceutical Solutions, Discovery Research and Integrated Parasitology. The SCYNEXIS Integrated Pharmaceutical Solutions division offers innovative chemistry and analytical expertise that we bring to bear on our customer problems. This expertise includes Method development and validation, Structure Elucidation, Impurity Resolution, Non-GMP and GMP API synthesis and CMC solutions.
What do you think the biggest drug development challenges are for biopharmaceutical companies today?
There are many challenges biopharmaceutical companies face today. One of the biggest and toughest challenges is the presence of unqualified trace impurities in your drug product. It can stop development in its tracks and put you under the microscope of the regulatory authorities. You need to know unambiguously what the impurity is, where it came from and its impact on your development program.
How can SCYNEXIS help companies face these challenges?
Using our robust, proprietary purification technology coupled with our integrated analytical and synthetic expertise we can rapidly isolate the trace impurities in high purity allowing us to elucidate their structure using NMR and MS. We can re-synthesize the impurities for unambiguous structural confirmation, qualify the material as a reference standard and determine the relative response factor of the impurity in comparison to the API. All of this is delivered rapidly allowing the clients’ development program to move forward.
How does SCYNEXIS differ from its competitors?
When it comes to impurity resolution, what we’re providing at the end of the day is not just the structure of the impurity. Through analytical, synthetic and regulatory understanding, we can help our client determine the root cause of these unqualified impurities. We provide high value data for a complete CMC package, which saves time and mitigates downstream regulatory complications for our clients.
How can our readers find out more about SCYNEXIS and its offerings?
They can get more information by visiting our website: www.scynexis.com. Readers can also e-mail me directly with any specific questions: [email protected]
Dr. Murray joined SCYNEXIS in 2001 and holdsa B.Sc. in Chemistry and a Ph.D. in SyntheticOrganic Chemistry from the University ofLiverpool in the UK. She is the author of 13papers and an inventor on 3 patents.