Implement Quality by Design (QbD) efficiently and cost-effectively

Connect Upstream for Quality by Design

Quickly establish your design space with our ambr® 250 mini bioreactors. Easily scale up to BIOSTAT STR® bioreactors with our new scale conversion tool. Simplify data analysis and knowledge management across scales with our MFCS SCADA system and integrated Umetrics software suite for design of experiments (DoE) and multivariate data analysis (MVDA).

 

"How to implement QbD efficiently
and cost-effectively is one of
today’s greatest challenges
in bioprocess development."

 

 

Sarah Xuyu Wang,
Technical Director, Bioprocess Solutions

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ambr® 250 modular

ambr® 250 minibioreactors are single-use and controlled by an automated workstation. They are ideal for generating a design space. The system builds on our successful micro-bioreactor technology, adding increased fermentation volumes as well as individual bioreactor temperature and impeller control. ambr® 250 provides an efficient, high-throughput scale-down model for process development and can easily be scaled up to our BIOSTAT STR® bioreactors.

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ambr® 250 high throughput

The ambr® 250 high throughput workstation is ideal for automating DoE approaches to cell culture process development in support of QbD studies. It allows the rapid evaluation of a wide range of bioreactor conditions and can be readily scaled-up to our BIOSTAT STR® single-use bioreactors. The workstation allows the independent, parallel control of 12 or 24 single-use bioreactor with working volumes of 100 to 250 mLs.

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MFCS | SIMCA MVDA

Our MFCS sets a new standard in bioprocess data management. It simply and efficiently allows data acquisition, monitoring and control of cell culture and microbial processes. It is a feature-rich, GAMP category 4 software package – based on over 25 years of experience and 3,000 installations worldwide. The integrated MODDE DoE for design of experiments (DoE) and SIMCA software for multivariate data analysis (MVDA) enables the fast and straightforward implementation of a QbD approach to drug development. The S88 tool enables easy and safe recipe transfer across scales.

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BIOSTAT STR®

The BIOSTAT STR® familiy consists of a range of completely single-use bioreactors with a conventional stirred-tank bioreactor design that is ideal for high-density cell culture applications. The range has true scalability from process development through pilot to production scales minimizing both the effort associated with scaling up cell culture processes and the risk of process transfer even to larger-scale bioreactors.

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Optimal Transition Between Scales

Simplify transitions between scales and ensure optimal scale-down experimental designs by using comprehensive bioreactor characterization data that covers our complete range of biroeactors from ambr® 250 to BIOSTAT STR® 2000. Our SCADA software and integrated chemometrics toolbox make it easy to implement your QbD strategy for robust and high-performance processes, while ensuring data consistency and easy retrieval.

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High-Throughput Bioprocess Development

Kistler, Pollard, Lee, Streefland (2016) Genetic Engineering & Biotechnology News (Vol. 36, No. 7) Apr 2016

Bioprocess engineers are achieving better process understanding and optimal cell culture conditions by using high-throughput scale-down methods and design of experiment (DoE) approaches.

This bioprocessing tutorial, published by Merck, explains how process development scientists can use the ambr® 250 automated bioreactor system to screen a wide process design space, while minimizing resources and materials. 

Read article from GEN

Superior Scalability of Single-Use Bioreactors

by Davvy De Wilde, Thomas Dreher, Christian Zahnow, Ute Husemann, Gerhard Greller, Thorsten Adams and Christel Fenge, September 2014

Design spaces that have been determined in the laboratory must be translated to the production scale. In this article the authors describe how the classical stirred-tank design of the ambr® 250, UniVessel® SU and BIOSTAT STR® bioreactors facilitates seamless scale-up using well established engineering principles while ensuring that product quality attributes are always achieved.

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Reducing Upstream Processing Scale-Up Risks Using QbD

by Mario Becker, Tim Ward and Christel Fenge, October 2016

Biopharmaceutical companies are increasingly adopting a QbD approach to control strategy development, spurred on by regulators and the promise of greater operating flexibility. Advances in upstream technology will make is easier for these firms to understand the link between their product critical quality attributes (CQAs) and critical process parameters (CPPs). This article describes how an upstream platform solution can shorten development timelines and reduce costs.

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Implement an efficient and cost-effective design space for easy scale conversions. Let us know your questions and requests. You will hear from us shortly.

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Quality by Design by
Prof. José Menezes, 4Tune Engineering,
at the European Upstream & Downstream Forum 2016

Biologics are three orders of magnitude more complex than drugs such as Aspirin. Prof. José Menezes, 4Tune Engineering, believes the biopharma industry can help ensure patient safety using a Quality by Design (QbD) approach that selects and aggregates the right PAT tools and then performs a multivariate data analysis (MVDA) on the acquired data. In this way, biotechnology companies can reach the market faster, compare batches more effectively and solve bioprocessing problems.

More about the Forum