Year: 2015-16

Company: Coherus Biosciences

Liaison(s): Vince Anicetti Parth Sampathukumar

Coherus BioSciences is a leader in developing and com-
mercializing biosimilar drugs of the highest quality and
value. This important new pharmaceutical category,
supported by regulators in the US, Europe and Asia,
is rapidly winning the trust of patients and healthcare
Founded in 2010 by an elite team of industry veterans,
Coherus BioSciences is devoted to expanding patient
access to these life-changing therapeutics in major regu-
lated markets around the world. The Coherus team
totals approximately 200 individuals.
Coherus partners with contract laboratories to perform
quality and stability testing on pipeline products. Re-
sults of these tests are recorded and organized in a da-
tabase, which is made accessible to Coherus through an
online web portal. Unfortunately, there are numerous
disadvantages to this system, including: long processing
times, non-intuitive navigation, multi-layered organiza-
tion of test results, and a lack of integrated quality con-
trol (QC) compliant analysis tools. Coherus is search-
ing for a quality solution that is easy to use, provides
a well-organized database, and offers integrated QC
compliant trend analysis.
The objective of the Coherus Team Master’s Project is
to develop or identify a robust and scalable system for
maintaining and analyzing test results. The high quality
solution system must manage thousands of data points
across various pipeline products, address 21 CFR 11
guidelines, and produce valuable graphical data for in-
house decision making needs. Further, the solution sys-
tem should offer real time analysis of data and mitigate
lag time in the delivery of test results from contract
laboratories to the Coherus Quality Department