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.
Thus, outsourcing of bioanalytical work has become a usual part of daily business for Biotech and Pharma companies especially, when additional capacity, specific technologies and/or GCP/GLP-compliance are required. However, a well-thought-out bioanalytical strategy, adequate vendor selection and proper management and control of outsourced activities are crucial to the success of drug/ vaccine discovery and development.
How we support bioanalytical strategy development & outsourcing
Following the proper analysis of the candidate selection/ development program and company organisation, we identify the bioanalytical requirements, options of bioanalytical strategies and outsourcing partner addressing the following vendor selection criteria:
Scientific and technical capabilities
History of authority inspections
Organisation and capacity
Optimizing discovery and development operations and activities
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 non-/ 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 respective decision matrices.