Set up OAA Project Parameters (Oligo Analysis Accelerator)
Click here to see this page in full context


Set up OAA Project Parameters

OAA project parameters are valid for all result sets in a project. Some of them can later be adjusted for individual result sets; the project parameters then serve as default values.

Prerequisites

  • An OpenLab CDS project must have been created in OpenLab Control Panel. One project is expected for each oligonucleotide compound you want to analyze.

  • To be able to carry out the procedure as described, you need the privileges that are by default included in the role Oligo Admin (see Roles and Privileges for Oligo Analysis Accelerator). Roles and privileges are configured in the Control Panel.

  1. In the Oligo Analysis Accelerator (OAA) web interface on the Data Selection tab, select the relevant project.

    2. The Projects list includes all projects in your OpenLab CDS system that you can access. Ensure that you edit a project that is intended to be run with the Oligo Analysis Accelerator.

    Do not define oligo analysis parameters for other projects. You will not be able to remove the parameters from the project.

  2. To edit the project parameters, click the three dots next to the project name, and select Project Settings.

  3. Provide the parameters for your project. For details on each parameter, see the following overview.

Result Set Information

Ion list

Provide a default ion list for all result sets in this project. The ion list can be overwritten for individual result sets. For details, see Ion List.

If you have already uploaded an ion list, and need to exchange it: Ensure that the file with new ion list has a different filename. A file with the same filename as the already uploaded one may not be recognized as different by the browser.

Compound

Provide the name of the full-length compound (FLP). The compound name can be overwritten for individual result sets.

Use exactly the same name and spelling as in the ion list.

MW Conversion Factor

Ratio of molecular weights of sodiated and free acid forms. See certificate of analysis for the reference standard.

System Suitability Criteria

Limits for "Passed" system suitability. Values outside the given range will result in a "Failed" flag.

Na Adduct Limit (%) ≤

Upper limit MS peak height of the sodium adduct compared to the MS peak height of the full-length product (FLP)

% RSD (UV Purity) ≤

% RSD of UV main peak area for QC standards

For example, 1.0

UV Purity (%) ±

Tolerated deviation of the average FLP UV purity of all QC standards from the value defined under Reference standard.

For example, 0.1

Mass Accuracy (m/z) ±

Max. acceptable difference between FLP expected m/z and the m/z value of the highest peak for QC standards average spectrum

For example, 0.2

UV Calibration Curve R² ≥

Determination coefficient from UV calibration curve calculation, acceptability limits for passing result

For example, 0.99

Based on mAU response- linear regression

The R² calculation is the same as in OpenLab CDS, see Calibration curve statistics

MS Calibration Curve R² ≥

Determination coefficient for MS calibration curve, based on sum of MS response for FLP and FLP, P=O; second order polynomial regression

For example, 0.99

The R² calculation is the same as in OpenLab CDS with Origin=Force, see Calibration curve statistics

RT Range Start

Lower range border for retention of UV main peak

For example, 12.0

RT Range End

Upper range border for retention of UV main peak.

For example, 22.0

Target concentration limit low (%)

Lower limit for the target concentration

For example, 75

Target concentration limit high (%)

Upper limit for the target concentration

For example, 130

Reference standard

Reference standard

Name of the working standard solution (WSS); from Certification of Analysis (CofA)

Lot number

Lot number of reference standard, per CofA

Conc. of Reference Standard (mg/ml)

Concentration (mg/mL) of the reference standard used for test, from CofA or Notebook

Reference UV Purity (%)

Purity of reference standard, typically supplied per CofA. This is not a calculated value. It is required for the calculation of system suitability criteria.

Acceptance Criteria

Acceptance criteria must be defined for different formulations.

Formulation

  • Drug Product (DP)- final, formulated drug that requires assay (that is, label claim for amount of active pharmaceutical ingredient or API in the drug product)

  • Drug Substance - The API, where the equilibrated material must be weighed out and water content determination is necessary.

UV purity (%)

Limit for passing result

MS purity (%)

Limit for passing result

Identity range (Da) ±

Range in Dalton added to the mass of the FLP

Label claim relative difference (%)

Limit for passing result, only editable for Drug Product