BioPAT® Process Insights Software - Predictive Bioreactor Scale-Up|Down
Biomanufacturers typically rely on spreadsheets to scale upstream processes. BioPAT® Process Insights software from Sartorius replaces spreadsheets to provide predictive scaling capabilities in an easy-to-use interface. Scientists, regardless of experience level, can evaluate multiple scaling parameters across multiple Sartorius bioreactor scales simultaneously to detect high-risk transfers earlier in process workflows, saving time, money, and resources.
BioPAT® Process Insights contains extensive characterization data for Sartorius bioreactors across a range of relevant conditions, reducing the need for costly and time-consuming engineering runs.
BioPAT® Process Insights uses an innovative calculation engine to evaluate process scalability and model the risk of transferring parameters between scales, taking any user-specified constraints into consideration.
Evaluate multiple scaling parameters across multiple bioreactor scales simultaneously, to detect high-risk transfers earlier in process workflows. This enables scientists to mitigate risks appropriately before reaching more expensive manufacturing scales.
Replace manual spreadsheets with an advanced calculation engine. An easy-to-use interface, utilizing guided templates that accommodate a range of users, from inexperienced to advanced scaling experts.
BioPAT® Process Insights promotes access and collaboration. A generous license for up to 10 team members facilitates teamwork and sharing of knowledge and best practices. The software provides workspaces for bioprocess scientists to consider various scale-up|down scenarios.
De-risk Parameter Transfer Early in the QbD Workflow
BioPAT® Process Insights Data Driven Software Application for Process Scaling
BioPAT® Process Insights minimizes the risks associated with conventional bioreactor scaling and design space exploration. The software combines unique scaling functionality with extensively characterized bioreactor data to deliver simplified, consistent scale-up between Sartorius Ambr®, Univessel® Glass/SU and Biostat STR® bioreactors. BioPAT® Process Insights helps you achieve Quality by Design (QbD), improves efficiency, and ensures faster time to market.
Predictive Bioreactor Scaling Calculations
BioPAT® Process Insights is a state-of-the-art software solution for predictive bioreactor scaling calculations.
- Replace spreadsheets to simplify scaling calculations.
- Improve bioprocess scaling with added novel functionality.
- Benefit from Sartorius’ extensive experience bioreactor scaling experience.
Facilitate Collaboration and Teamwork
BioPAT® Process Insights facilitates collaboration and teamwork.
- Collaborate effectively with a generous, 10-seat license.
- Take advantage of guided templates, which accommodate users of varying skill levels.
- Build workspaces to consider various scale-up and scale-down scenarios; all workspaces can be shared across the team.
Simplify Scale Conversions for Sartorius Bioreactors
BioPAT® Process Insights was built from the ground up to simplify scale conversions for Sartorius bioreactors.
- Access extensive characterization data for a range of Sartorius bioreactors.
- Reduce the need for costly and time-consuming engineering runs.
- Predict design space for process development to maximize use of supported Sartorius bioreactors.
Handle Complex Scale-up and Scale-Down Scenarios
BioPAT® Process Insights contains powerful calculation engine to handle complex scale-up and scale-down scenarios.
- Evaluate multiple scaling parameters across multiple bioreactor scales simultaneously.
- Consider any user-specified constraints in scaling calculations.
- Detect high-risk transfers earlier in bioprocess development workflows.
Why is Bioreactor Scaling Important?
To produce enough of your biologics for clinical trials or mass patient use at the lowest cost of goods, as a biopharmaceutical manufacturer, you need to ensure that your production processes scale effectively and efficiently from process development through to manufacturing.
Upstream scaling involves transferring your process, including its critical process parameters, cells, products, and physical environment from one scale to another. When done correctly, this ensures your product quality, quantity, and biologic’s behavior at your final scale matches what you expected at your starting scale.
However, scaling from one bioreactor to another is not simple and requires mimicking the biological, physio-chemical, and mechano-structural properties of the cellular micro-environment as you move between different vessel volumes. Failure of process runs during process transfer due to poor scale-up can be expensive, potentially costing up to 100 EUR/g for a 2,000 L bioreactor.
Frequently Asked Questions
Upstream process development and production of suspension batch and fed-batch cell cultures in Sartorius single-use and Univessel® Glass bioreactors such as:
- Protein-based therapies (e.g. monoclonal-antibody/biosimilars) expressed in CHO cell lines
- Viral-vector applications
BioPAT® Process Insights software helps with the scale-up and scale-down of cell culture processes across supported Sartorius bioreactors, from small bioreactors (starting at 15 mL) to large bioreactors (up to 2,000 L). The software allows the user to determine in silico whether the process is scalable and can be transferred between process development and manufacturing bioreactors.
- A server (can be physical or a virtual machine) within a private network
- Access for each user is via a PC connected to the server with either Google Chrome or Microsoft Edge installed
Note that installation is carried out by the customer (not Sartorius). Please consult our experts for further details and refer to the technical specifications document for the minimum and preferred hardware and software requirements.
After placing an order, an automatic confirmation email is delivered with a link to the My Sartorius portal and an Activation ID and the software application is downloaded from the portal.
The software can then be installed within your organization’s private network by your IT team.
- The software is accessed via a browser (Google Chrome or Microsoft Edge) using your organization’s private intranet
- Internet access is not a requirement to use the software
On-Demand Webinars:
Related Assets
Compatible Systems
Ambr® 250 High Throughput
High throughput, automated bioreactor system for process development with 12 or 24 single-use 100–250mL mini bioreactors.
Explore Ambr® 250 High Throughput
Biostat STR®
A range of Analytics and Sensors for Uni-/ Multi-variate Data Gathering: Real Time Monitoring & Control.
Univessel
High throughput, automated bioreactor system for process development with 12 or 24 single-use 100–250mL mini bioreactors.
Explore Ambr® 250 High Throughput
Ambr® 15 Cell Culture
Automated microbioreactor system for cell line development and process optimization, with 24 or 48 single-use 10-15mL microbioreactors.
