Aegyris

About Aegyris™

A Comprehensive software solution for the bioanalytical laboratory

Somru scientist have developed software solution to enable bioanalytical laboratories to meet rigorous scientific and regulatory requirements. Aegyris streamlines assay design and execution, data analysis and ensuring 21 CFR Part 11 compliance.

The web front-end of Aegyris provides a rich user interface for data analysis and visualization. It drives laboratory productivity, ensure compliance, and streamline processes by using simple easy-to-use intuitive wizard-based interface.

Aegyris™ is designed to enable bioanalytical scientists to perform method validation, statistical analysis, and validation workflow management in a streamlined and regulatory compliant manner. The IntelliLab module within Aegyris is designed to streamline day to day laboratory activities involving inventory, sample tracking, and electronic laboratory notebook (ELN).

Aegyris™ can save up to 70% of time and costs in method validation support activities when implemented as designed.

A Comprehensive cloud based software solution for the bioanalytical laboratory.

A Comprehensive software platform for bioanalytical laboratory

Aegyris™ contains following functionalities:

Method Validations

PK, Immunogenicity, Biomarker (including multiplexing) and Biosimilar

Productivity Tools (IntelliLab)

Sample tracking using RFID

Inventory management

eLabEx (Electronic Lab notebook)

Artificial intelligence driven data analytics

21 CFR Part 11 compliance

Modules that are designed independently as micro-service for inter-operability

Scalability

Direct link to various LIMS or data system

Aegyris Bioanalytical

Biomarker

Multiplexed biomarker assay data analysis accurately... read more

PK - Pharmacokinetics

Automated generation of validation experimental design including plate maps... read more

Trending

Proactive monitoring of assay performance and detecting potential assay issues before they fail... read more

Immunogenicity - Anti Drug Antibodies

Calculate immunogenicity cut points (screening, confirmatory and titer) in one click... read more

Biosimilar

Perform parallelism testing which is critical to establishing analytical similarity... read more

Aegyris™ Immunogenicity

The Immunogenciity module is designed to streamline immunogenicity (also known as anti-drug antibodies assay) method validation. The user friendly assay workflow guides scientists to execute validation assays, perform data analysis and generate reports in a regulatory compliant manner. The powerful statistical engine allows for robust calculation of assay cutpoints (i.e. screening, confirmatory, and titer)

The flexible configuration options allow scientists to comply with their internal standard operating procedures. The immunogenicity module includes the evaluation of the following assay parameters as per FDA/EMA Immunogenicity Method Validation Guidance.

Documentation - Validation plan & report

Screening Cut Point

Confirmatory Cut Point

Titer Cut point

Precision and Acceptance Criteria

Determination of Low Positive Control

Sensitivity

Hook Effect

Selectivity

Specificity

Stability

Summary Precision

Aegyris™ PK

The PK module is designed to streamline pharmacokinetic assay validation. The user-friendly assay workflow guides scientists in executing validation assays, performing data analysis, and generating reports in a regulatory compliant manner.

The flexible configuration options allow scientists to comply with their internal standard operating procedures. The PK module includes evaluation of the following assay parameters as per FDA/EMA/ICH Bioanalytical Method Validation Guidance.

Documentation - Validation plan & report

Calibration Curve Model

Accuracy and Precision

Total Error

Selectivity

Specificity

Sensitivity

Dilutional Linearity

Short and Long term stability

Aegyris™ Biomarker

The bioanalytical laboratories are increasingly asked to performed challenging method validation of biomarkers to support regulatory decision making. The importance of fit-for-purpose method validation in biomarker’s context of use was also highlighted in recent FDA bioanalytical Method Validation Guidance (2018).

To meet the demand from the bioanalytical community, Somru BioScience has developed separate biomarker method validation module within Aegyris platform that meets the need of the industry and the intent of the global regulatory guidances. The Biomarker moldule allows for validation workflow management and data analysis for up to 10 analytes sultaneously.

The biomarker method validation module offers following functionality. In addition, the trending module within Aegyris allows for trending of data enabling confirmation of assay performance, reagent suitability and endogenous analyte stability.

Documentation - Validation plan & report

Screening Cut Point

Confirmatory Cut Point

Titer Cut point

Precision and Acceptance Criteria

Determination of Low Positive Control

Sensitivity

Hook Effect

Selectivity

Specificity

Stability

Summary Precision

Aegyris™ Biosimilar

Biosimilar method validation presents unique challenges to bioanalytical scientists. In addition to ensuring that all the validation parameters mentioned in PK module, for Biosimilar method validation, bioanalytical scientists are also required to demonstrate that one method can measure both innovator and biosimilar in comparable manner. This requires sophisticated statistical measures and robust data analysis tools.

The Aegyris Biosimilar module includes all the components of PK module. In addition, it also includes following parameters.

Standard curve comparison

Quality Control (QC) Comparison

Analytical Similarity Evaluation

Statistical measures to confirm one assay approach

Aegyris™ Trending

Perform proactive monitoring of assay performance and detect potential assay issues before they fail using Aegyris™ Trending component.

Automated set up of Trend analysis reports - for a specific time range between two dates & times or for a dynamic time range (e.g. last 30 days etc)

Allows for comparisons among multiple variables. For example- between operators or lot of reagents etc.

Statistical analysis (e.g. ANOVA, regression analysis, correlation etc.) for entire dataset or subset of data

Accuracy and Precision

Transformations: producing a new time series from an existing one. Useful for biological data

Automated identification of root cause based on artificial intelligence

Warning of assay performance issues before the assay starts failing based on machine learning algorithms

Automated link to LIMS system for routine upload

Upcoming feature will include robust statistical approaches such as Curve-fitting/ growth curve, Filtering/Smoothing/ weighting, Kwiatkowski–Phillips–Schmidt–Shin (KPSS) test, MANCOVA (Multivariate Analysis of Covariance) , The Seasonal Kendall test (SK test) analyzes data for monotonic trends in seasonal data.

Aegyris™ Productivity

Smart Inventory

Smart real time inventory tracking and critical regent life cycle management... read more

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RFID Sample tracking

Bioanalytical module contains 5 component (PK, Immunogenicity, Biomarker, Biosimilar, Trending) for streamlining... read more

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eLabEx

The electronic worksheet allows real time critical assay data capture and management backbone of any scientific experiment in your lab... read more

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State of The Art AI Engine

Bioanalytical module contains component streamlinin data analysis

Statistical analysis engine

Uses standard R library package

R library packages being validated by multiple well recognized organization

Communicates with Aegyris Base via ESB using HTTP API

Automated identification of discrepancies between Validation plan and report

Automated warning and error notification for deviation from regulatory guideline

Powerful Reporting

Bioanalytical module contains 5 component (PK, Immunogenicity, Biomarker, Biosimilar, Trending) for streamlining data analysis.

Bioanalytical module contains 5 component (PK, Immunogenicity, Biomarker, Biosimilar, Trending) for streamlining.

Report is configurable and customizable

Val Report contains 3 types of data

Free form text

Non-editable template information (e.g. compliance statement)

Result table from Aegyris™ data analysis

Will need data tables and plate maps to construct appropriate template

Report can be exported in various format (e.g. MS word or PDF)

Ready for Your Audit

The audit trail is automated, secure (can’t be edited), contemporaneous, traceable, and archived

Audit trail content includes – identification of user, date and time stamp, record Id, original value, new value, reason for change and electronic signature

Configurable data retention policy

Archiving

Data is locked and stored in archive directory with limited access

Ability to load data on application with limited user access (read only) upon request and approval

Ability to integrate with third party document management software

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Resources

Aegyris Brochure

An Integrated Bioanalytical Method Validation Software for PK, Immunogenicity, Biomarker, and Biosimilar Assays

Vaccine Method Validation

Somru BioScience utilizes Aegyris to streamline Vaccine method validation

Aegyris for Trending Biomarker Data

Somru BioScience utilizes Aegyris for trending Biomarker data and improve method performance

Comprehensive software platform for bioanalytical laboratory

Automate method development and validation data analysis

Improve laboratory productivity and increase capacity

Implementation and Validation

Aegyris Brochure

Vaccine Method Validation

Aegyris for Trending Biomarker Data

Comprehensive software platform for bioanalytical laboratory

Automate method development and validation data analysis

Improve laboratory productivity and increase capacity

Implementation and Validation

Aegyris Brochure

Vaccine Method Validation

Aegyris for Trending Biomarker Data

How similar is your biosimilars?

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