An article in a Special Issue of Bioanalysis on Assay Transfers has been written by Richard Hucker, Director of Regulatory Bioanalysis at A4P and Richard Abbott, Director of Bioanalysis , Merck KG . The article is summarised below:
One of today’s most significant challenges in bioanalysis is when assay methods are being transferred. This can be when a new laboratory and set of users is being used within the same organization, very importantly when an outsourcing solution is being implemented or when circumstances demand, multiple laboratories running the same assay simultaneously need to be used.
In today’s development paradigm asset ownership is much more fluid with vastly increasing numbers of collaborations and partnerships in drug development, multiple sources of product substrate and the decline in the one size single centre internal drug discovery resource previously found in “big Pharma”.
As the extant of bioanalytical outsourcing grows a likely consequence is that the oversight and management of the method transfer process for assays is going to become increasingly critical. Data continuity and maintenance of quality, often where projects are run with significant time gaps within them, is paramount and delivering a return on investment is vital.
The reasons for moving assays are multiple and all can and will impact on success. However, and fundamentally, effective forward planning, detailed project management and active communication amongst the stakeholders remain the keys to success.
Despite a significant effort in harmonizing bioanalytical regulations and guidance’s across various authorities, there is surprisingly little standardization and commentary about how assay transfers can work and what factors are relevant.
A4P provide the expertise, knowledge and experience in achieving successful method transfers at whatever stage of drug development and whatever circumstances are prevailing.
We can deliver your solutions though our consultancy approach, by engaging our resource for particular targeted issues or by contracting us to entirely manage the project from sample to submission.