Analytical Development
As part of our analytical development activities we establish reliable and robust methods to monitor the quality attributes of a new biological entity (NBE). These methods are crucial for guiding product development activities, ensuring safety and efficacy, and confirming that applicable standards of identity, strength, quality, and purity are met.
Analytical Methods for Process Design
The analytical methods we develop support process design activities to ensure processes deliver the desired product quality. We transfer methods to Quality Control (QC) teams to support lot release testing of GMP batches. Methods may also be used to characterize products, analyze toxicology lots and reference standards to support our partners.
Initial Analytical Platform Method Fit
We perform an initial analytical method platform fit assessment using material provided by our partner. This provides insight into the properties of the molecule, as well as confirming that our analytical platform will support a given project.
Method Development
We can perform additional development on platform methods if needed. Our experts can develop product-specific assays, such as ELISA based binding assays, charge heterogeneity methods, and cell-based assays.
Method Robustness and Qualification
Representative material from process design lots is used for qualification and the robustness testing of methods. We demonstrate method robustness using a phase appropriate Design of Experiments (DOE) approach and statistical evaluation. Our experts perform phase appropriate method qualification for purity, charge variant, process impurities, and potency release methods using material from a representative lot. We typically adopt a co-qualification approach between analytical development and QC to qualify and transfer methods efficiently. Depending on the method being qualified the qualification parameters will include specificity, linearity, range, precision, accuracy, stability-indicating properties, and as needed an assessment of the Limit of Detection/Limit of Quantification.
Compendial Assays
We adhere to USP and/or EU compendia for Drug Substance lot release testing.
Characterization
We have a range of characterization methods available to support programs as needed. This includes approaches such as:
- LC-MS/MS peptide mapping
- Intact mass LC/MS
- Disulfide mapping
- Light scattering
- Excipient quantitation
- Glycosylation profiling and quantification
- Effector function assays
- Process reagent clearance testing
- Host Cell Protein identification
