Step 2: Process Development
Speed up Process Development and Gain Process Understanding Early on
Run More Development Projects in Parallel
12 or 24 experiments in parallel with our new fully automated minibioreactor system ambr® 250 and succeed with more development projects in parallel at lower cost. Speed up optimization of your cell culture process conditions, generate predictive process data and scale-up with confidence to our large scale single-use bioreactor platform Biostat® STR thanks to the fully scalable proven stirred tank design. With integrated DoE and MVDA software tools, you can implement QbD strategies early on to define your design space and gain process understanding at moderate resource investment. Use our BioPAT® MFCS for all your process data, from early process development to production and translate your process information into knowledge easy, rapidly and reliably.
To learn more read the article on 'Rapid Early Process Development Enabled by Commercial Chemically Defined Media and Microbioreactors' published by BioPharm International. Read now
High Throughput Automated Process Development
250 ml True Stirred Tank Bioreactor Design Provides Step Change Improvement in Lab Productivity
Our high throughput multiparallel bioreactor system ambr® 250 comes with single-use bioreactor vessels and easy-to-use software. This enables scientists to manage multiple experiments in parallel whilst reducing the costs per experiment. Fast turnaround of up to 24 Easy Connect vessels with single-use pH and DO probes in less than 1 hour. Fully automated media fill and inoculation, flexible, automated fed-batch strategies and sampling.
Generate Predictive Small Scale Data
Simplify Scale-up and Scale-down Activities
Our rigid-wall and bag bioreactor vessels featuring a single-use, stirred-tank design are based on proven engineering principles known from glass and stainless steel bioreactors: central stirrer shaft, choice of Rushton turbine and low-shear 3-blade segment impellers, geometric similarity of vessel and impeller dimensions, and comparable ring- and microsparger designs. We support your scale-up and scale-down activities with extensive bioreactor engineering data on mixing time, oxygen transfer and power input.
Rationalize Process Development and Optimization
Integrated Design of Experiments and Multivariate Data Analysis Software Tools
We enhance our bioreactor functionality with a broad range of sensors, analyzers and bioprocess optimimized process control and software tools.Take advantage of the BioPAT® Chemometrics Toolbox and integrate the capabilities of advanced multivariate methods into your existing process control software BioPAT® MFCS | win. Identify critical process parameters and their optimal ranges and estimate a design space. Compare batches and scales, identify key trends, correlations, patterns and relationships.
Expertise in Process Development and Scale-up
Let us Work with you to Optimize your Process, CAPEX and OPEX
Our team of Process Development and Upstream Experts supports you to optimize your upstream process, from cell line and media development to process optimization and characterization. Let us help you to take your process from development to manufacturing, providing a holistic view on monoclonal antibody processing, connecting upstream and downstream, and sharing our knowledge on the latest innovative technologies.
Early Phase mAb Platform Process Development Team
This presentation explains how the Process Development team takes mAb development support to the next level through an integrated network of experts and services. The PD team will support you in selecting the right clone, performing high throughput screening and upstream process scale-up, guidance and execution of a complete list of analytical tests and complete downstream process development know how through to bulk drug substance.