Biotech analytics is a complex business. This is because of the equally complex nature of biological products. Therefore their testing and release require a wide variety of techniques to help identify and quantitate them. However, it is not only the active component that needs testing but also residuals derived from the manufacturing process. We also need to ensure that no contamination has occurred during processing & that the starting materials were clean to begin with.
A wide variety of methods are used to test products that include methods that in nature are biophysical, molecular biological, biochemical and cell based, some of which literally need creating while others are specified in pharmacopeial monographs that need to be verified as suitable and carefully adhered to.
However, creating the methods is only the beginning. We need to demonstrate that the methods are fit for purpose given their importance for ensuring the products are both safe and efficacious. Consequently we need to validate our methods. Regulatory guidance exists on the Qualification and Validation of analytical methods and is provided by regulatory bodies and agencies such as the ICH, FDA and EMA. GRA can help you not only understand the guidance but work with you to apply it in an pragmatic and efficient manner, ensuring that the data that you generate is not only technically sound but also adequately positioned and documented from a regulatory perspective that should result in smooth sailing during your critical regulatory submissions.
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