THE ASSIGNMENT
Help their client, a global drug and medical device manufacturer, gain approval of an antibacterial suture from the European Union Regulatory Agency.
THE CHALLENGE
The EU Agency had never reviewed such a product before.
THE ANTIBACTERIAL-COATED SUTURE WAS THE FIRST OF ITS KIND.
THE ISSUES
The coating, considered a drug by the EU agency, had been approved years before…BUT the suture would have to be reviewed as a combination product.
THE CLIENT ASSUMED A COMPLETE REVIEW WASN’T NECESSARY...BUT THE EU DRUG AUTHORITY DECIDED THAT THE STANDARD APPROACH DID NOT WORK! A FULL DRUG REVIEW WOULD BE NEEDED – INCLUDING ADDITIONAL IMPURITIES DATA THAT EVEN THE CLIENT HAD NO KNOWLEDGE OF.
THE TIMING
The estimate the internal team submitted to generate the impurities data was a full 12 months.
FOR THE STAKEHOLDERS, 12 MONTHS WAS AN UNACCEPTABLE TIMELINE. THE PRODUCT HAD ALREADY BEEN ON A DELAYED SCHEDULE AND THIS WOULD HAVE BEEN A SERIOUS SETBACK.
THE SOLUTION
Without the appropriate resources to provide answers within the shortened timeline, QUANTUM was asked to step in as the CRO of record and act as an extension of the client team to solve the missing data issues.
QUANTUM HAD A SOLID RELATIONSHIP WITH THIS CLIENT, BUILT FROM PREVIOUS PROJECTS THAT DEMANDED HIGHER LEVELS OF EXPERTISE AND A GUARANTY OF QUALITY.
THE APPROACH
Using high-resolution GCMS with isotopic dilution, QUANTUM would compare the relative response of the natural impurity to its isotopic analog – to guide development of the appropriate analytical methods that would generate the requested data.
“BY FULLY UNDERSTANDING THE REQUIREMENTS OF THE METHOD AND THE NATURE OF THE COMPOUND WE CAN EVALUATE PARAMETERS AND IDENTIFY CRITICAL QUALITY ATTRIBUTES. THIS RESULTS IN METHODS THAT ARE FIT FOR PURPOSE, RANGED PROPERLY, AND QUICKLY VALIDATED”.
Since QUANTUM had previously supported the brand supplier of the API used in the suture coating, they had a much clearer idea of what kind of molecules could form trace impurities in the manufacturing process.
ANOTHER LAB TEAM MIGHT HAVE ASSUMED THAT TESTING ALL POTENTIAL IMPURITIES WAS ESSENTIAL. FORTUNATELY, EXPERIENCE AT THIS STAGE SAVED COUNTLESS HOURS OF EXPENSIVE, AVOIDABLE EFFORT.
