S-Matrix Analytical Development Labs Services

Our proven capabilities are now available to you as a service!

S-Matrix Analytical Development Labs (ADL) takes a unique approach to method development:

• All work is done using Fusion QBD, which implements a Quality by Design (QbD) approach 100% aligned with regulatory guidances and expectations, and enables us to rapidly develop truly robust and transferrable methods.
  [ICH Q2(R1), Q8(R2), Q9 – Q11] / [USP ⟨1220⟩, ⟨1224 – 6⟩]

Define Your Analytical Target Profile (ATP)
We work with you to define quantitative statements of your required method performance. The ATP is used to assess project progress, and is the basis of your verification and acceptance of the final delivered method.

Analytical Target Profile (ATP)
"The concept of an ATP parallels the concept of a Quality Target Product Profile described and defined in ICH Q8. The ATP defines the requirements for the `product` of the test procedure, which in this case is the reportable result. Criteria defined in the ATP refer to the quality data attributes of the reportable result, i.e., accuracy and measurement uncertainty, which include all sources of variability, including precision. Identifying the output of the analytical procedure as the reportable result provides a target for development and helps to ensure the procedure is developed toward predetermined performance requirements that are directly linked to the quality of the data. In other words, the ATP defines the objective of the test and quality requirements, including the expected level of confidence, for the reportable result that allows the correct conclusion to be drawn regarding the attributes of the material that is being measured..."
Proposed New USP General Chapter: The Analytical Procedure Lifecycle ⟨1220⟩

Integrate Quantitative Metrics of Method Robustness
We integrate robustness modeling for all key performance characteristics — as specified in the ATP — into method optimization to assure successful validation and transfer.

Execute the Project According to Quality by Design Principles

We optimize the method in terms of mean (average) performance and method robustness consistent with established FDA and ICH guidances, and formally establish the method’s Robust Design Space and Proven Acceptable Ranges (PARs) — referred to by Analytical QbD practitioners as the Method Operable Design Region — MODR.

Perform a Full Suite of Pre-validation Experiments
We qualify the method’s performance according to established FDA and ICH guidances to verify the ultimate validatability of the method. These experiments include: