“Biological materials have a mind of their own”
AroCell’s research and development staff members started a valuable collaboration with Future Diagnostics in the Netherlands in 2011, for the development of the TK 210 ELISA test throughout all these different phases. Collaboration between AroCell team members and this extended contract assay development organization has led to many product milestones along the way.
The process of assay development is challenging and complex: going from an exploratory phase to testing and developing different types of antibodies to feasibility and optimization, verification, transfer to the manufacturing and validation of the technical and clinical performance of an assay. Quality assurance and control standards must be met throughout these processes.
Mike Martens, co-founder and current Managing Director of Future Diagnostics has experience in development of assays for a large part of the in-vitro diagnostic community since 1997, ranging from large companies, such as Phillips, Abbott and Beckman and smaller niche companies such as AroCell. He recalls some of the challenges and opportunities from the start of the collaboration on TK 210 ELISA in 2011:
“We had some major challenges along the way, but there will always be challenges and complexities in developing a product like the TK 210 ELISA. There were challenges in respect to the reproducibility of the assay and the use of some critical materials from the very beginning, related to the antibodies, along with changing focus and knowledge on clinical disease areas. But these challenges in the collaborative effort led to the development of several new patents, and new opportunities. A good example is our joint presentation with AroCells’ Product Manager Helena Wensman at the World Biomarker Congress in Philadelphia 2016”.
Read the full article about the challenges and opportunities from the start of the collaboration on TK210 ELISA in 2011: