Process Knowledge: Continuity for Therapeutic Production

Sartorius Process Knowledge Ensemble for Cell-based Therapies

IND changes in phase III are 3 times more expensive to make than in phase I. Avoiding late-stage changes when scaling to clinically relevant cell yields requires building deep process knowledge early in development. However most early development is done with conventional methods (like flasks) that have limited transferability into clinical production. The mismatch in technologies between stages of development creates inefficiencies that end up costing significant time and money.

The Sartorius Process Knowledge Ensemble brings together cell culturing technologies that enable early process optimization with clinical transferability. By building foundational process knowledge, you can use the Ensemble to establish critical process parameters and critical quality attributes earlier, helping you improve your timelines to IND submission and clinical manufacturing.


 

 Standardize

Increase performance and save time on revalidating across stages of development with scalable bioreactors and lot-to-lot consistent RUO to GMP media and reagents

 Secure

Ensure successful cell therapy manufacturing by building process knowledge early on with scale-down process optimization that seamlessly transfers to full-scale processes

 Scale

Rapidly scale up to reach clinically relevant quality cell numbers and bring life-saving cell therapies to patients

Gene's Journey Digital Game

Help Gene advance his cell-based therapy through discovery, development, and manufacturing in this interactive digital board game.

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Accelerate Your Cell-based Therapy Development With Process Knowledge

Ambr® 250 Modular

State-of-the-Art Process Development

  • 2, 4, 6, or  8 single-use 250 mL bioreactors – all processes managed via a single user interface
  • Interchangeable bioreactors allow flexibility for mammalian and microbial applications with the same hardware
  • Intuitive and powerful software suite

Biostat® RM TX

Rocking Motion Bioreactor for Cell Therapy Applications

  • Different cultivation modes are possible: Fed-batch, perfusion processes or a combination of both
  • Complete qualification of the system for GMP use to ensure regulatory compliance
  • Easy connection to industry standard Distributed Control (DCS) or Supervisory Control and Data Acquisition (SCADA) systems such as BioPAT® MFCS, Siemens PCS 7 or Emerson Delta V. Straightforward integration into existing automation and single-use infrastructure for data and process consistency throughout.

UniVessel® SU

The Efficient Tool for Process Development

  • Conserved geometry from Ambr® 250 to UniVessel® to Biostat STR® 2000 for easy scalability
  • Working volume range: 0.6 - 2 L
  • Interchangeability with glass vessels decrease bottlenecks during peak workloads

Biostat STR®

Offering the Flexibility and Scalability You Need

  • Conserved geometry from Ambr® 250 to UniVessel® to Biostat STR® 2000 for easy scalability
  • Working volume range: 12.5 L to 2000 L
  • Synchronized hardware | software | consumables:
    • Biobrain® industrial controller with modern, intuitive HMI
    • Bag holder with integrated temperature, gassing, and sensor control
    • Flexsafe STR® bags with a stirrer and sparger design optimized for predictable mixing and gassing performance

MODDE®

Intuitive DOE Software

  • Design of Experiments (DOE) is the fastest and most cost-efficient way to design effective experiments and increase productivity
  • Provides full flexibility and advanced tools for complex and varied investigations alongside an intuitive design wizard making it the perfect tool across experience levels
  • Make the most of valuable samples, raw materials, and human resources by enabling data-driven decision making

SIMCA®

​​​​​​​Multivariate Data Analysis Software

  • SIMCA® provides a comprehensive toolbox for data mining, multivariate data analysis (MVDA), and model interpretation
  • Build robust models from historical data, carry out systematic investigations to discover sources of variability and predict future behavior to proactively avoid problems
  • Create informative data visualizations to extract and communicate insights quickly and effectively

BioPAT® Process Insights

Enabling Rapid and Predictable Process Scale Up

  • New standalone software application for Sartorius bioreactors
  • Enables predictive scale conversion and low risk process transfer
  • Offers extensively characterized bioreactor data, all in one place

Umetrics® Studio

In Silico Simulations for Faster Process Development

  • Leverage in-silico models to reduce the number of experiments in process development, saving time and costs.
  • Ensure optimal cell culture performance, regardless of the cell-based modality and independent of the bioreactor brand and model
  • Enhance decision making by coupling in-vitro cell culture experiments with machine learning and mechanistic knowledge  of cell behavior and metabolic pathways

BioPat® Toolbox

Build your Process Analysis Capabilities

  • Enable continuous inline monitoring with The BioPat® Toolbox
  • Manual sampling is not required and since a sample is not removed the reactor volume is unaffected
  • Faster measurement results through data integration

4Cell® Nutri-T | MSC NutriStem® XF | NutriStem® hPSC XF

Xeno-free, serum-free media formulated to achieve excellent yield

  • Xeno-free, serum-free; serum addition is not required to achieve excellent yield
  • Excellent performance with low initial seeding concentrations
  • Manufactured in accordance with ISO 13408 guidelines

CellGenix® Preclinical Growth Factors and Cytokines

Exceptional batch-to-batch consistency purity and sterility

  • Lyophilized for a longer shelf life
  • Animal component free
  • Seamless transfer to GMP

SoloHill® Microcarriers

Promotes excellent cell line attachment and growth with conditioning needed

  • Size range from 90 – 212 µm
  • Xeno-free or animal protein coated options
  • Currently used in FDA approved therapies

Explore Cell Booster Bundle

Build your ideal bundle for cell culture with our selection of media, growth factors, cytokines, and microcarriers.

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Want to learn how Sartorius can help you achieve your development goals?

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