Method development and validation services

AffinityImmuno offers method development and validation for a range of biological molecules. We support customers at various stages of the development and validation process and have a proven track record of success on full development and validation studies, optimization of existing research methods and transfer of previously validated methods.

• We develop strong and transparent relationships with clients to develop and validate methods to achieve their end goals.
• We perform all method validation according to ICH guidelines and will meet the requirements established by regulatory agencies.
• We meet regularly with clients to ensure a timely delivery of services.

Services

Method Feasibility and Development

We discuss method requirements with our clients prior to starting development work to ensure that the appropriate scope is defined. During development and feasibility, we evaluate several attributes including accuracy, precision, specificity and linearity to ensure the method is suitable for validation and to avoid any failures in the acceptance criteria.

Method Validation

We validate methods following the EP/USP general chapter and the ICH guidelines. Prior to beginning validation, we ensure that the client has input into the validation protocol.