BioPharmaSpec’s Director of Quality, Daniel Binet, and Technical Director, Dr. Richard Easton discuss how we can make sure characterization methods are fit for purpose, despite not being performed to GxP, and have confidence in the data generated.
The data from protein characterization studies are used to make crucial development decisions and to truly understand the structural attributes of a biopharmaceutical. Characterization reports are supportive to a regulatory submission and for this reasons developers want to be confident that the data has been generated using scientifically sound protein characterization methods. This becomes crucial when methods are repeated over a period of time, for example batch-to-batch comparisons or biosimilar to innovator comparability studies.
The key to achieving this confidence is the implementation and use of a meaningful and well-design quality system. This system should consider all aspects of Quality from the arrival of samples into the lab through to project planning, analysis, data interpretation, report preparation and data archive. Standard Operating Procedures (SOP) should be in place to cover all such aspects and should be regularly monitored and updated as necessary.
Daniel talks in detail about how Quality is managed at BioPharmaSpec to ensure clients can have the greatest confidence in the management of their outsourced structural characterization studies.