Advent has extensive experience in assay development. Our laboratory is able to develop and validate analytical methods for:
- Safety testing;
- Cell and Molecular Biology.
ADVENT combines a skilled team, a product-oriented approach as well as state-of-the-art facility, equipment and software to design fast and reliable analytical methods.
The analytical development team works hand in hand with the process development team, in order to proceed quickly from a pre-GMP phase to the production of clinical batches.
- Method Development
Developing new methods or optimizing existing ones.
Analytical procedures in the early stages of method development are initially developed based on a combination of an understanding of the basic methodology and prior experience. Experimental data from early procedures are often used to guide further development. An analytical procedure is developed to test a defined characteristic of the substance against established acceptance criteria for that characteristic. In the development of a new analytical procedure, the choice of analytical instrumentation and methodology should be based on the intended purpose and scope of the analytical method. The important parameters that may be evaluated during method development are specificity, linearity, limits of detection (LOD) and quantitation limits (LOQ), range, accuracy and precision.
- Method Qualification
In accordance with protocols adapted to the product development phase.
The method qualification is intended to prove that the assay is fit for purpose. Method qualification is performed in the early stages of process research and pre-clinical development (e.g., Phase I) when regulatory guidelines do not require a full validated assay for releasing clinical batches. In comparison with a full method validation, the method qualification is a less complex study that may be completed in a shorter time frame and at a lower cost. Qualification studies are used to determine method performance such as specificity, linearity, accuracy, and precision as required for an intended application.
- Method Validation
According to protocols compliant with International Council for Harmonization (ICH) guidelines Q2(R1).
Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice.
Analytical methods need to be validated or revalidated:
- before their introduction into routine use;
- whenever the conditions change for which the method has been validated (e.g., an instrument or samples with a different matrix);
- whenever the method protocol is changed-
Listed below are validation performance characteristics that are required from ICH Q2 (R1) guidelines for each of the categories of assays and that are considered for method validation.
+ signifies that this characteristic is normally evaluated
(1) In cases where reproducibility has been performed, intermediate precision is not needed
(2) Lack of specificity of one analytical procedure could be compensated by other supporting analytical procedure(s)
(3) May be needed in some cases