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A Move to Outsourcing - Access Scale-Up Capacity and Custom Kit Development

Case Study

The Project Situation

An emerging molecular diagnostic company had developed a probe-based assay for viral detection and was trying to determine the most efficient way to bring their kit to market. Their facility had R&D capabilities but the capital investment required for them to begin their own diagnostic grade production was prohibitive for a company of their size and experience. The project required an ISO 13485 quality system, molecular biology grade reagents, sterile filtration and customized functional quality control.

Our Operational Support

We set up a dedicated product transfer team that worked with the client to fully understand their unique goals and requirements for kit manufacturing. The client was able to leverage our extensive IVD manufacturing expertise during the technical transfer of their original specifications and processes, which allowed for the seamless integration of the client’s protocols into our robust quality systems.

The Customized Solution

Using our vast reagent portfolio of over 300,000 chemicals and network of global supply chain partners, a private kit configuration was created in our ERP, which included a customer-defined master manufacturing formula (MMF), master packaging formula (MPF), quality control report (QCR) / final product specifications (FPS), raw material specifications (RMS) and label text form (LTF). A complete batch record is generated with each new lot and maintained on file. At the client’s request we maintain a lot retention program to support long term quality assurance. Our highly skilled packaging engineers worked closely with the client's Marketing Department to produce a stunning, full color box for the kit, complete with the client's graphics and IVD regulatory markings. The client chose to have us print their labels on-site for each reagent using the company’s highly controlled labeling production suite.

Quality assurance is at the heart of all of our operations including broad analytical capabilities and complete non-conformance investigation. For this project we employed our purpose-built global facilities and network of supply chain partners to provide the client with a broad range of QC test methods suitable for the manufacture of this particular diagnostic kit.

Results

Following the success of this pilot-scale phase, which initially only required a few hundred kits, we helped the molecular diagnostics company validate their products for full commercialization and now produce thousands of kits every year. The company was able to address capacity and production constraints through custom OEM solutions developed by our team of experts. This type of collaboration helped establish a close partnership and led to more discussions around designing future kits using our other OEM capabilities and global infrastructure. We are proud to partner with this client, and those around the world, looking to free up resources and scale-up manufacturing capacity, in order to develop diagnostic manufacturing solutions that directly impact human health.

Give us a chance to propose a solution as unique as your business challenge and let us prove that we can be your trusted OEM partner. Contact us today!