Year: 2016-17

Company: Coherus BioSciences

Liaison(s): Vince Anicetti, Michael Choy

Coherus Biosciences, a leading developer of biosimilar drugs, has several products at various milestones, including the filing of a Biologics License Application for their pegfilgrastim biosimilar in 2016. Founded in 2010, the company is committed to providing accessible and affordable quality pharmaceuticals to patients. Increasing public pressure for a reliable supply of pharmaceuticals has driven policy change within the FDA. To better support manufacturing of quality product, the shift towards a risk-based inspection approach will require companies to implement or update their quality metric systems. Quality metrics can provide an objective picture of company operations by ensuring that processes are performing within licensed specifications. They also allow both regulators and companies to identify quality issues, which could affect the supply of drugs. For a company that outsources its production, quality metrics are powerful tools enabling comparison of one product across multiple contract manufacturing organizations ( CMOs ), thereby facilitating appropriate corrective actions. Given the quantity of information that Coherus receives, the team is assisting Coherus in filtering and processing the raw quality data to yield usable and actionable information to mitigate risks. The project deliverable is to develop Excel-based data visualization scorecards that sort and present deviations, Corrective Action and Preventive Action ( CAPA ), change controls, Out-of-Specification ( OOS ), and Out-of-Trend ( OOT ) values at Coherus CMOs to facilitate Coherus ability to identify trends.