What to do when the standard approach doesn’t work.

Some products represent uncharted territory for a regulatory agency. When this occurs, even the largest organizations can struggle when a seemingly small problem becomes a major roadblock. Check out our latest case study and see how an analytical approach from an independent lab cleared the way for this well-known product.

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 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 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 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.

QUANTUM had a solid relationship with this client, built from previous projects that demanded higher levels of expertise and a guaranty of quality.

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.

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”.

Dr. James Menoutis, PhD.

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.

The Insight

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.

The Result

With this strategy, the 12-month timeline was dramatically reduced - to just 60 days.

With the successful submission of the additional data, the client was able to receive final approval of the product.

The Value

The total savings in terms of time, resources and recovered sales from the original 12-month estimate was over 1.8 million.

The value of your CRO is not about speed or even the latest lab equipment – but about the advantage that an experienced and consultative ally brings to the process. The pressure in the industry to qualify and advance potential drug candidates into the pipeline is more complex and demanding than ever before. Is your lab up to the challenge?

Call (800) 448-2968 to speak with one of our Experts, or for more information on our Testing and Consulting Services