Analytical development and validation
Analytical Development and Validation: methods tailored to your product
At Naobios we have a dedicated team experienced in method development, validation and transfer. Our in-house capabilities ensure that we can implement and validate the analytical assays required for an adequate and tailored quality control strategy needed for in-process control and for the characterization of the quality attributes of your product in the context of process development (USP and DSP) or GMP manufacturing.
General method development
Through our significant analytical and regulatory experience, we are able to develop a method that is best suited for the expected purpose of the assay.
For a description of methods applicable to viral based products that may be developed by our team, please refer to our GMP compliant testing webpage.
Our development capabilities span the full range of assays needed to test for purity, identity, potency and safety of the manufactured material.
Naobios is supported by its sister company Clean Cells, an internationally renowned specialist in quality control testing.
– Method validation and or Qualification –
Our team of experts ensure that the analytical methods are validated in compliance with global regulatory guidelines and in particular ICH Q2(R1).
The validation or Qualification strategy will be adapted according to the analytical assay characteristics, process requirements and to the clinical phase of the investigational product.
Process and cleaning validation testing
Our QC team is responsible for the testing during Aseptic Process Simulation (APS) for aseptic productions to ensure that the process and the product are sterile, Including the testing required to qualify aseptic gowning during production under aseptic conditions.
Our team also performs testing for process cleaning validation and for validation of disinfectants.