IDBS Polar, a platform that securely manages drug progression in contexts of workflow, integration, and insight.

Polar delivers:

• Workflows designed to simplify the BioPharma Lifecycle with process-aware planning, design and execution of end-to-end bioprocess and analytical unit operations.

• Integrations that bring meaning to your data. Rapid integration into your development ecosystem, enabling automation and curating a process-centric data backbone.

• Insight driven by highly contextualized process quality data. Enhance process understanding with out-of-the-box analytics. Transform your biopharma lifecycle with modeling & simulation. Industry-Leading Security and Compliance: 21 CFR 11 / GxP compliant - ISO27001 certified- SOC 2 and SOC 3 reports available.

IDBS Polar | BioAnalysis

IDBS Polar BioAnalysis enables CROs and biopharma to improve quality and reproducibility, reduce study cycle times and accelerate time-to-market.

Best practice workflows

Ensure quality and reproducibility.

Registration

Integrated inventory management including sample lifecycle.

• Samples

• Materials

• Equipments

50% REDUCTION IN SAMPLE PREPARATION DOCUMENTATION

Planning

Enable Study Directors and Principal Investigators to define the recipes, procedures and parameters of the methods and assays that will be conducted, ensuring that execution is repeatable.

• Reagent Recipe

• Method Definition

• Analyte Solution Recipe

• Ligand Binding Assay Definition

• Method Validation Recipes

100% ELIMINATION OF DEVIATIONS SPECIFIED WITHIN THE METHOD

Execution

Document the procedures and preparations of bioanalysis, ensuring quality while retaining flexibility. Capture data in a consistent and traceable way, flag exceptions in process for immediate correction or explanation, and log all items used including genealogy tracking.

• General Equipment Check

• pH Meter Check

• Balance Check

• Pipette Check

• Reagent Preparation

• Analyte Solution Preparation(s)

• Analyte Solution Preparation(l)

• Sample Setup (LIMS)

• Procedure

• Instrument Setup

• Sample Setup (non-LIMS)

• Ligand Binding Results Import

75% REDUCTION IN QA/QC TIME

Reporting

Summarize results across the execution workflows within a study including the calibration curve, quality controls, validation and stability assessment sample.

• Equipment Check Report

• Exception Report

• Usage Log

• Post Process

• Ligand Binding Study Report

• Ligand Binding Validation Report

50% REDUCTION IN OVERALL STUDY DURATION

IDBS Polar | BioProcess

IDBS Polar BioProcess optimizes workflows and integrates both process and analytical data to deliver greater insight

Best practice workflows

Drive efficiency, quality, and insight

The journey towards the vision of Biopharma 4.0 starts with improved process understanding and characterization. Accelerate return on investment and reduce implementation risk with out-of-the-box workflows and reports that mirror core bioprocess development and sampling activities from cell line development through to analytical development.

Polar BioProcess workflows offer out-of-the-box biological inventory management linked to a comprehensive data model, thereby maintaining the genealogy of product development and enabling the inputs and outputs of each unit operation to support the execution of adjacent steps. Capture process data at the point of execution in a consistent and standardized manner and automate calculations to remove the burden and risks associated with manual transcription. The result is better documented process execution and reporting to help you develop more robust, scalable and transferable bioprocesses.

Cell Line Development

Full traceability for the development of optimized mammalian and microbial cell lines

• Transfection

• Cloning

• Clone Screening

• Cell Freezing

• Cell Thaw & Revival

80% REDUCTION IN TIME GATHERING DATA FOR REPORTS

Upstream Processing

Maximize the productivity and scalability of mammalian and microbial cultures

• Cell Expansion

• Bioreactor

• Harvest

• Cell Lysate Preparation

• Resuspension & Wash

60-70% TIME SAVINGS IN DATA ANALYSIS

Downstream Processing

Optimize unit operations for effective product recovery and purification

• Tangential Flow Filtration (TFF)

• Column Packing

• Column Unpacking

• Chromatography

• Filtration

• Solubilization & Refold

30% REDUCTION IN REWORK

Analytical Development

Streamlined support for in-process testing and analytical method development

• Plate-Based Assay

• UV-VIS

• Gel-Based Assay

• HPLC

• Free Thiol

• icIEF

• qPCR

• Visual Appearance

• Requester

• DNA Extraction

CONNECT ANALYTICAL DATA WITH THE PROCESS

Reagents

Manage reagent recipes and record reagent preparation (media, buffer, etc.) with integrated laboratory equipment connections and inventory management

• Recipe Creation

• Reagent Preparation

ELIMINATE ERRORS SUCH AS USING EXPIRED MATERIALS

Reports

Interactive reporting tools for monitoring process data, efficiency and quality provide the process insight required for a continuous improvement-led approach to development. Development and implementation of unit operations is a data rich environment: data that can be leveraged to achieve process understanding, tech transfer and enable efficient scale up.

• Exception Report

• Bioreactor Comparison

• Campaign Report

50% REDUCTION IN TIME TO PREPARE BLA CHAPTER 3

IDBS Polar | Insight

Let Polar Insight help you optimize your processes with analytics-powered decision making

Eliminate cumbersome and time-consuming manual data alignment and integrity risks from the import/export of poorly contextualized and siloed data sets. With embedded AI/ML and visual analytics, Polar Insight enables you to design, run and analyze processes in a single platform for end-to-end visibility, traceability and effective optimization. Unlock much needed capacity and focus resources on activities with the greatest impact on quality and performance.

What Is Polar Insight?

Polar Insight is the engine within Polar that delivers AI/ML-powered analytics directly to the end-user for decision-making.

Whether you are striving to better understand the performance of your equipment and processes or looking to transform the way you work with model-based insights, poorly contextualized and siloed data is holding you back.

Navigating this complexity typically requires specialist IT tools and/or data science teams who spend upwards of 80% of their time cleansing and aligning data, slowing your path to insight.

With embedded AI/ML and visual analytics, Polar Insight aligns with digital workflowsand seamless data capture from your equipment, instruments and systems.

• Design, run and analyze experiments and processes in a single digital platform for end-to-end visibility, traceability and effective optimization

• Eliminate cumbersome and time-consuming manual alignment and data integrity risks from import/export of data sets

• Reduce reliance on specialist analytics tools and/or data scientists

• Unlock much needed capacity and focus resources on activities with the greatest impact on quality and performance

Polar Insight supports end-to-end analysis from data access, reporting, visualization and exploration, accelerating BioPharma development and reducing the time to commercial readiness

Design of Experiment (DoE)

DoE is an essential tool to assess the criticality of process parameters during process development. DoE provides significant advantages over one-factor-at-a-time (OFAT) experimentation and is often used in process characterization studies to determine acceptable ranges of process parameters to deliver quality product. However, DoE is difficult to implement because it requires third-party tools, statistical expertise and manually exporting/importing and aligning data sets.

With Polar Insight DoE, you can create your experimental design with just a few clicks, record experimental results in the same digital system of record and understand which parameters are critical to quality based on statistical analysis. Reduce the number of experiments you need to run to gain process understanding, optimize performance and support regulatory compliance.

Multivariate Analysis (MVA)

Each process step, material and equipment used can lead to variations in drug product quality.

Single parameter analysis for process characterization doesnt consider interactions between process parameters and material attributes or their influence on the final product, often allowing problems to go undetected.

Polar Insight MVA provides advanced statistical techniques, including PCA (Principal Component Analysis) and PLS (Partial Least Squares), to find relationships among multiple process parameters.

This powerful methodology can be used for efficient root-cause identification for process variability, efficient process monitoring and early detection of potential issues to avoid losing batches downstream. It supports overall process understanding and optimization for control of biologics development and manufacturing processes to ensure product quality.

Bioreactor Comparison

Siloed data and lack of standardized data formats across different bioreactor scales and projects make it difficult to monitor and compare bioreactor runs. Polar Insight Bioreactor Comparison provides interactive visualizations for exploration and comparison of all bioreactor runs within a campaign, including control parameters, process variables and quality attributes. Using these visualizations enables process development scientists to easily explore and understand their process parameters across bioreactor cultures; both for monitoring currently running processes and comparing data between historical processes.

Bioreactor Data Export

Easily select and download comprehensive datasets for custom processing in specialist tools such as Minitab, JMP, etc. Polar Insight Bioreactor Data Export allows data selection through state-of-the-art visuals including bar charts, line graphs, scatter plots and more. No SQL knowledge is required.

• Data Selection

• Multi Criteria Bar Chart

• Ranking Bar Chart

• Parameter vs Elapsed Time

• Multi Parameters vs Elapsed Time

• Scatterplot

Cell Line Genealogy

Collating all the data required to accurately portray cell line genealogy across numerous different experiments is often time consuming and error prone. With Polar Insight Cell Line Genealogy, you can quickly uncover the history of a cell culture and understand relationships between cultures at any point, including extended lineages and availability.

Equipment Management Dashboard

Polar Insight Equipment Management Dashboard allows you to view all scheduled calibration and maintenance events in a single calendar view, making it easier to plan tasks and improve lab efficiency.

Project Tracking Dashboard

When the primary focus is analyzing experimental results during a study/project rather than operations, it can be challenging to identify and address bottlenecks. Polar Insight Project Tracking Dashboard enables project managers to track progress and share deadlines, increasing efficiency and collaboration. Seeing the status of all work currently ongoing including elapsed and touch time, number of repeats and other key quality metrics enables project managers to take corrective action when needed.