With the industry getting into more complex and novel treatment modalities e.g. with proteins and even more though with protein constructs, bioassay development and validation has become more challenging requiring a good level of science and technical capabilities. External service providers are continuously specializing in bioanalytical techniques and have become experts in this field. And they have implemented the infrastructure and organisation that allows them to opperate in compliance with GLP/ GCP regulations.
For Biotech companies it is too much an investment to run a laboratory for conduct of bioanalytical investgations especially when state-of-art technology and GXP compliance are required. Proper management and control of outsourced activities can be quite demanding with respect to the time and capabilities needed. Thus, engaging Ando would allow Biotech Companies to focus fixed-cost resources on core competencies and more critical business activities.
Our identification criteria
Following the proper analysis of bioanalytical requirements in close collaboration with our client, we carefully identify potential service providers.
Scientific and technical capabilities
Organisation and capacity
At the end of the evaluation process, we support decision-making by providing a decision matrix and our recommendation on the service provider of choice.
We assist contract negotiations and professionally manage the outsourced bioanalytical project in close collaboration with both the service provider and client to meet the assay development goals, timelines and budget. We drive scientific discussions with the service provider, evaluate data, development and validation reports as well as bioanalytical plans for clinical sample analysis.
In case a decision by the sponsor is required on more complex matters related to the outsourced bioanalytical activity, we simplify decision-making by providing decision matrices.