oem-13485-compliant-manufacturing

Case Study

The Project Situation

A prominent diagnostics company and innovator in the field of Genomics was needing to collaborate with a partner to develop target enrichment solutions for Next-Generation Sequencing.

Our Operational Support

Within our ISO 13485-certified quality management environment, we worked closely with the customer's R&D team to provide the Index Adaptors for their Next Generation Sequencing (NGS) application, and completed the performance testing of the adapters (including library manufacturing and deep sequencing). The goal was to significantly reduce the Index Adaptor cross-talk (vs. Adapters generally available from the instrument manufacturers) to allow efficient multi-plexing.

The Customized Solution

We developed a custom manufacturing process for the Next Generation Index Adaptors and were able to guarantee very low levels of cross-talk. For this project, constant communication and open dialogue was key between both company’s teams of R&D scientists. This allowed for the sharing of data and in-depth NGS analysis in order to maximize product yield. We also developed a proprietary HPLC process in order to achieve high levels of purity and meet the client’s specific product requirements. This collaboration continued through the Quality Control phase, whereby we implemented release methods that were equivalent to the client’s own release methods. Formal accelerated stability studies and recommended expiry dating was also provided to the client through rigorous sample analysis. After entering into a formal supply agreement, the client chose to provide all necessary packaging materials for the kitting process. We worked with these custom materials and developed a streamlined and automated process for manufacture of the client’s private-label kits.

Results

Customer-generated data suggests that our manufactured Index Adapters showed significantly less (< 50% in most cases) Index cross-contamination relative to the previous "gold standard" in the industry (available through a leading NGS instrumentation provider). Feedback from the product’s end users have been quite positive as well. The client has continued to work with us on the manufacture and packing of their kits and even increased their forecasted production schedule.