Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
Use the Biological Assay Package for potency analysis of biological assays. The add-on comes equipped with a highly flexible test system to qualify your assay. You can perform combination calculations to obtain the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
Use Quantitative response assay documents to calculate the potencies of test samples relative to an established standard. You can also use them to determine absolute potencies based on stock solutions or raw materials.
Find details on the advanced setup of Quantitative response assay documents.
Overview of the PLA 3.0 software, its ongoing improvements and version updates, and the available trial options.
Structural foundation for daily work and support for method development from initial design to routine production.
Find details on the system requirements for the Biological Assay Package add-on and the steps to install the add-on in your environment.
Use Basic bioassay protocol documents to set up a workflow for producing reportable values from multiple independent assay runs. Organize complex methods, retest scenarios, and report several products in a single assay.
Use Combination of assay results documents to perform combination calculations for independent assay runs, thus obtaining reportable values for the potency.
Use Equivalence margin development documents to develop and verify test systems based on historic assays and apply these test systems in new development of quantitative response assays.
The Quantitative response assay document type supports a range of quantitative response or dilution assay types, that is, parallel-line potency assays, parallel-logistic potency assays, and slope-ratio potency assays.
Quantitative response assay documents use a set of concepts you should be familiar with when working with this document type.
Use response data processing to configure the processing of response data, for example, to subtract the absorbance of blank wells or to divide response values by the mean absorbance of maximum binding wells.
Use regression models and simultaneous regression to set up regression analysis for your assay elements.
Data selection schemes define which data PLA 3.0 considers in the analysis. You can select, for example, which data points or dilution steps you want to include. The default scheme simply selects all data points.
Use Analysis of Variance (ANOVA) to determine sources of variation in statistical models. ANOVA employs several methods to estimate variance in the data. It then tests to what extent the results agree. PLA 3.0 supports two ANOVA models, that is, pure-error ANOVA and residual-error ANOVA.
Assays are based on curve similarity. Suitability tests allow you to check the validity of calculations every time they are performed. We therefore recommend you set up suitability tests for every quantitative response assay.
Run the calculation once you have completely set up the assay document. Results of the calculation are added to the assay document.
The methods and procedures provided by the Quantitative response assay document type are based on use cases and requirements from literature.
Use Test system definition documents of the Biological Assay Package to define a collection of suitability tests and corresponding margins for Quantitative response assay documents.
For some biological assays, determining relative potency within a single run is not sufficient. In these cases, you perform multiple individual assay runs and then combine the resulting data to obtain a more reliable final potency estimate. The challenge is to combine these individual results efficiently and reproducibly, particularly in regulated environments or when preparing for automated workflows.
Find reference information on the document types of the Biological Assay Package add-on.
Use the bioMérieux Endotoxin Detection Assay Package add-on to perform endotoxin testing based on recombinant factor C (rFC), a synthetic alternative to naturally sourced reagents derived from horseshoe crabs, as offered by the bioMérieux company.
The Control Chart Package allows sophisticated statistical process control (for example, by plotting Shewhart I-Charts as recommended in the USP <1010>). It provides visualization options for intervals, subcharts and sidecharts, and allows you to define colors by a secondary characteristic. You can also define rules based on events and time frames.
Use the Dichotomous Assay Package to analyze biological assays based on quantal (binary) responses by fitting probit or logit models to estimate the potency of your samples.
The Dose-Response Analysis Package provides various biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves, provides enhanced data processing, and options for subgroup analysis.
The Microbial Assays for Antibiotics Package for PLA 3.0 is your software for assessing the potency of antibiotics. This add-on supports various methods, that is, cylinder-plate, turbidimetric, and combination of microbial assays. It enables you to closely follow the guidelines laid out in the United States Pharmacopeia (USP <81>) and the Japanese Pharmacopoeia (JP 4.02).
Find details on add-ons that support and supplement data analysis add-ons.
Import of external response values and observation data into PLA 3.0 for further processing and evaluation.
The user interface of PLA 3.0 includes graphical and textual elements designed for daily workflows.
Deployment, installation, and update of PLA 3.0, including initial and advanced setup.
The licensing solution of PLA 3.0, available licensing options, and the activation and management of licenses.
Setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
PLA 3.0 supports users in achieving compliance with regulations such as ISPE GAMP® 5 and 21 CFR Part 11.
Stegmann Labs serves as the sample lab for scenarios illustrating the use of PLA 3.0 across bioassay analysis workflows.
Definitions of central terminology used in PLA 3.0.
