Analytical Methods Development
Benefit from our fully managed analytical methods development service. Utilize our extensive knowledge and expertise to deliver analytical methods suitable for in-process analysis and release testing.
With you on your biologics journey...
Why analytical methods development?
Defined analytical methods are required to establish all biological products’ identity, purity, physical characteristics, and potency.
3P’s analytical methods development services
We have expert knowledge of recombinant proteins, including monoclonal antibodies, vaccines, fusion proteins, growth factors, and enzymes. In addition, our laboratories contain state-of-the-art equipment encompassing a wide range of technologies supporting analytical methods development. Analytical methods development is based on the principles defined in ICH Q6B guidelines. We develop methods that are adapted to the biochemical and biophysical properties of the molecule and its critical quality attributes.
We select the methodology for the intended purpose early in the development process, supporting in-process control (IPC), release, and/or stability testing. Finally, the robustness of the chosen method is evaluated for inclusion in the final product release panel.
We conduct analytical methods development activities in-house, leveraging our experience and techniques efficiently using design of experiment (DoE) tools. We provide various platform methods for common molecule or host types, evaluating the capability to accommodate the sample and matrix before progression to methods qualification and validation.
What we will deliver
We provide a fully managed analytical methods development service utilizing our extensive knowledge and expertise, delivering analytical methods suitable for in-process analysis and release testing of the product in development.