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Header Image - Bioprocess Data Management, Data Analytics and Statistical Consulting

Become a highly adaptive biotech company with Exputec inCyght®. The software can help you integrate all unit operations for the complete product life cycle. Connect your people, and departments such as quality, process development, validation and operations. This ensures safe and robust process design for small and large scale. Accelerate your commercialization including regulatory filings with inCyght. Get the process intelligence and visibility you need to run your biotech processes in real time.

Manage, analyze, and report bioprocess development, validation and operational GMP data with the leading real-time bioprocess data analytics software inCyght®

 

 

inCyght® combines data management, data visualization & statistical analysis from all data sources in one intuitive software environment

With the help of inCyght®, scientists and engineers find root causes of process variation, identify processing trends and increase the efficiency of process development.

In conjunction with Exputec’s statistical consulting, inCyght® enables the streamlined realization of process characterization, process validation and technology transfer projects.

 

inCyght® Key Features

 

Intelligent Data Visualization for all Unit Operations

inCyght® offers an intuitive visual analytics environment for the intelligent visualization of all process data types. The unique inMatrix visualization concept intelligently selects the right visualization scheme for your process data. This enables scientists and engineers to simultaneously plot data from all unit operations to detect trends and correlations.

Flexible Bioprocess Data Management for Laboratory and Manufacturing

inCyght® offers management of time series, sensor, quality and spectral data as well
as video- and image data. A broad spectrum of customizable database filters enables
you to quicky identify relevant batches, unit operations and data types required for your
analysis. Soft sensors enable you to extract maximum information from process data in your database. The out of the box data management functionalities are ideal for process development, process validation and quality trending / biosimilarity activities. inCyght® offers
fast integration of all process relevant data sources via real-time connection to laboratory
equipment and high throughput process development equipment, drag&drop browser
import for tabular data as well as server crawl functions.  Content Packs

The Must-Have Analytics Tools for Statistical Analysis

Similarity analysis features enables user-friendly and statistically sound analysis of scale-ups, technology transfers and unit operations. Using multivariate and univariate statistical tools engineers quickly identify processing trends and correlations. In addition, statisticians can directly connect to the database using R and Python connectors for advanced and flexible statistical analysis. The out of the box statistical tools fullfill the requirements for process validation, technology transfer and quality trending/ biosimilarity statistical analysis. Content Packs

Strain Information Management & Analysis

inCyght® manages and visualizes strain geneologies. This enables scientists and engineers to freely explore genetic modifications performed on production strains in combination with strain performance and growth data. In addition, lab managers create the neccessary GMO documentation according to the local GMO legislation.

FDA 21 CFR Part 11 Compliance

Exputec inCyght® features Audit Trail, Access Protection, Copies of Records, Record Retention, Electronic Signatures and a Validation Roadmap to meet FDA 21 CFR Part 11 and
EudraLex Annex 11 requirements. For detailed information on the compliance package
please download our whitepaper.

 

Request a personal demo

We’d love the opportunity to demo inCyght® to your team, answer your questions and explore whether inCyght® would be a good fit. Request a demo now and one of our experts will get in touch with you shortly.

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Customer Voices

inCyght for GMP Quality labs: Bioequivalence Testing

As a leading analytical service provider and biotech laboratory in the field of Biosimilars, we support many customer projects involving biosimilar clone screening as well as comparability studies. Our clients need to select the right clones with minimal analytical effort and highly consistent data. With inCyght® software, we now have a tool in hand to explore which clones or process conditions perform most similarly to the originator product. Furthermore, we can explore which process parameters and settings achieve the highest biosimilarity score.

Rainer Fedra, Head Analytical Development at VelaLabs GmbH

Exputec inCyght® bioprocess software at biotech R&D site at Evonik

  • Successful roll-out of Exputec inCyght® at R&D unit of Evonik’s Business Line Animal Nutrition in Künsebeck.
  • Operators, scientists, engineers use Exputec inCyght® for bioprocess development and optimization.
  • Manifold bioprocess equipment sucessfully integrated for data analytics using Exputec inCyght®.
  • Seamless integration in existing IT infrastructure.

Digitalization and Data Analytics to Accelerate Bioprocess Development

“We found an excellent realization partner in Exputec. The project team is very focused on our business needs and all interfaces are running smoothly and reliably. The collaboration is excellent.”

Read more about this collaboration.

inCyght software as collaborative data analytics platform

“We use inCyght Software  for data management, data analytics and as collaborative platform in the multi-partner EU project CrossCat”

 

 

Ass. Prof. Oliver Spadiut

inCyght for Scale-Up and Scale-Down of Biopharmaceutical Processes

Scale-dependent challenges were overcome for the successful scale-up of a biopharmaceutical manufacturing process and the qualification of scale-down models. This was achieved using similarity analysis for the qualification of  bioprocess scale-down modelsroot cause analysis workflows and improvement of scale-up based on industrial best practices.

Dr. Sandra Abad

Activating the Design Space for cGMP manufacturing

Using InCyght data analytics software from Exputec, users create integrated process models and soft-sensors. Models can be implemented as soft-sensor function-blocks in Siemens DCS for manufacturing under cGMP and Part 11 compliance.

Dr.-Ing. Bernd-Markus Pfeiffer
Content PacksFunctionality ComparisonSystem Requirements

CONTENT PACKAGES


Exputec’s pre-configured content packages provide a jump-start for deploying Exputec inCyght® to solve process development and manufacturing challenges. They are based on the industry's best practices and the know-how of Exputec consultants and reflect the requirements of bioprocess development, operation, as well as validation scientists and engineers.

 

Bioprocess Design, Analysis & Control

Exputec inCyght® Bioprocess Analysis content packages offer pre-configured mass balancing workflows, data analysis workflows, soft-sensors and reporting templates to analyze and report bioprocess data. By using Exputec inCyght® Bioprocess Analysis content packages along with the associated comprehensive consulting services, inCyght® users extract maximum information from bioprocess data.

Content packs for following unit operations are available:

  • Microbial fermentation
  • Cell culture fermentation
  • Preparative chromatography

Biopharmaceutical Process Validation

Exputec inCyght® Biopharmaceutical Process Validation content packages along with the associated comprehensive statistical consulting services, provide a software guided framework and statistical tools for solving bioprocess development and manufacturing challenges.

Content packages for the following tasks during the bioprocess lifecycle are available:

  • Scale-down model qualification
  • Design and execution of process characterization studies
  • Analysis and reporting of technology transfers

Quality Trending & Biosimilarity

Exputec inCyght® Quality Trending & Biosimilarity content packages along with the associated comprehensive statistical consulting services, provide a software guided framework and software tools for advanced data management, trending and statistical analysis of quality data.

  • Management of all quality relevant data types (a.o. Bioassay, HPLC, ELISA)
  • Univariate and multivariate analysis of similarity and bioequivalence
  • Quality trending dashboards using univariate- and multivariate control charts

FUNCTIONALITY COMPARISON


Functionality

inCyght® Viewer

inCyght® Professional

inCyght® Enterprise

Data Upload
Data Visualization
E-mail Helpdesk Support
Statistical Data Analytics
Feature-based Data Analytics
inCyght Plug-Ins: 1 Plug-In included
User Management Administration
Numerical Computing Environment
Dashboard Development kit
inCyght Server License (1 customer server)
inCyght SaaS Data Backup for 10.000 Batches

 

For additional information and pricing please contact us.

 

SYSTEM REQUIREMENTS


inCyght® Fermentation Expert - Installed on the desktop PCs of the users
Processor Intel Core i5 or higher, 64-bit CPU required
Memory 4 GB (8 GB recommended)
Hard drive 2 GB free space during installation, 1 GB after install required
Operating System  Microsoft Windows 7 or later (64-bit required)
Browser  Mozilla Firefox, Google Chrome or Microsoft Edge / Internet Explorer (10+)
inCyght® Web - Installed on a server and access via Intranet
Server Different envronments supported (e.g. Linux or Windows based, 64 bt required), Docker based installation
Processor Multicore 64-bit
Memory 8 GB (depending on user number)
Hard drive 6 GB for installation of software (SSD recommended) + additional storage for data
Client Operating system Microsoft Windows 7 or later, Linux (64-bit required)
Browser Mozilla Firefox, Google Chrome, Microsoft Edge / Internet Explorer (10+)