Elypta's Contract Manufacturing Case Study

“Our mission at Elypta is to prevent cancer mortality through early detection by metabolism-based liquid biopsies. For a small company like ours, working with an organization like Merck to manufacture our diagnostic provides credibility for us, something that is very important, especially in the early stages.”

Karl Bergman, CEO, Elypta

The Project Situation: Support for Elypta’s Liquid Biopsy Kit

For many types of cancer, diagnosis relies on tissue biopsy in conjunction with medical imaging. In addition to sometimes being inconclusive, biopsies are associated with risks, high costs, and inconvenience for patients, making them ill-suited for screening or tracking disease progression. In contrast, liquid biopsies –sampling and analysis of body fluids – offer the potential for a minimally-invasive, safe, and convenient means of diagnosing and monitoring cancer. If sufficiently accurate, these tests offer the potential for earlier detection, increasing the chance of curative treatment.

Elypta is developing the first-ever metabolism-based liquid biopsy platform for early detection and improved monitoring of multiple cancer indications as compared to that of genomics- and proteomics-based approaches. The test, which is being developed to identify the presence of glycosaminoglycans (GAGs) in blood, urine, cells, and tissues is currently being evaluated in a clinical trial for early detection of recurrence after surgery in patients with high or intermediate risk clear cell renal cell carcinoma, a setting in which there are no molecular tests available. Changes in the balance of GAGs may reflect disorders of the tumor microenvironment and provide insight into tumor progression.

Our Operational Support for the Liquid Biopsy Kit Manufacturing

Elypta partnered with us to produce the first standardized extraction kit for GAG quantification in bodily fluids for research use. The method underlying the Elypta MIRAM™ Glycosaminoglycan Kit uses ultra-high-performance liquid chromatography and tandem mass spectrometry to accurately measure the concentration and structural composition of chondroitin sulfate (CS), heparan sulfate (HS), and hyaluronic acid (HA).

In addition to extensive manufacturing expertise and capabilities, our team brought additional benefits to Elypta as summarized by Karin Mattsson, Elypta’s Vice President of R&D:

• Support was provided across all manufacturing steps allowing Elypta to focus on the long development project and ongoing clinical trials.
• Our R&D team members developed processes and locked down test specifications while dedicated project managers with manufacturing backgrounds ensured timely advancement towards key milestones.
• All necessary documentation such as validation plans and test methods for manufacturing and quality control were generated in a timely manner.

The Results of Elypta’s Glycosaminoglycan Kit CMO Project

Elypta now offers the first standardized service for full spectrum glycosaminoglycan quantification using the Elypta MIRAM™ Glycosaminoglycan Kit (for research use only). Merck’s contract manufacturing services move Elypta one step closer to meeting growing customer demands for this novel research assay as the company advances along the regulatory path.

Ensuring Success of Elypta’s Liquid Biopsy Platform

To ensure the long-term success of a project like this, we will work closely with Elypta to assess and mitigate supply chains risks.  In addition, quarterly business reviews are in place to review current and anticipated demand for the kit. Long term, global demand is also evaluated; each of our production sites has a three-to-five-year outlook and we collaborate with our customers and sites to determine the best strategy to help our customers grow and effectively meet demand in any geography.

CMO Support for Future IVD Assay Projects

The development, scale to production, and commercialization of your IVD assay is a lengthy and expensive investment. Whether you are producing bottles of reagents or complex multi-component kits, we are an experienced and trusted partner for clinical diagnostics companies planning to outsource their manufacturing projects. We provide contract manufacturing services across a broad spectrum of client needs with proven processes and systems that ensure technical support and reliability at all stages of development.

To learn more about our Contract Manufacturing Capabilities for the clinical diagnostics industry, or discuss your project with our assay development specialists, visit our IVD services page Diagnostic OEM & CMO Services.