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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Fast tracking a QbD Approach

by Mario Becker, June 2017

To facilitate QbD for upstream processing, Sartorius Stedim Biotech (SSB) has ensured the geometric similarity of its bioreactor range from the ambr® 250 systems through to the BIOSTAT® STR 2000 single-use bioreactor. Bioreactors across the entire range have been fully characterized and the data is available for clients. Learn more about fast tracking your QbD in this guest blog post by Mario Becker, Director Fermentation Technologies North America at Sartorius Stedim Biotech.

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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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Our Latest Upstream Innovations:

Full at-line integrated analytics for ambr® 15

Combining the ambr® 15 and the Nova Biomedical (Nova) BioProfile® FLEX 2 allows fully integrated and independent sampling, sample transfer, analysis and automated feedback control in each single-use ambr® 15 bioreactor. Up to 16 different cell culture parameters including: total and viable cell density, pH, CO2, dissolved Oxygen (DO), glucose, lactate, Na+, K+, Ca+ and osmolality can be sampled and measured with a complete cycle time of just 6-7 minutes. The ambr® 15 software simultaneously acquires the FLEX 2 data set and processes it, for example calculating how much feed volume to automatically add during a run.

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Quality by Design – Develop your scalable design space

Nova BioProfile® FLEX2

BioProfile® FLEX2 combines Nova’s groundbreaking MicroSensor Card technology with optical measurement and freezing point osmometry for an automated and comprehensive cell culture analyzer. Compared to the previous generation BioProfile® FLEX there is no maintenance for any of the 11 chemistry and gas sensors, sample volume for the full text menu is reduced by 75% to 265 microliters (400-500 microliters when integrated with ambr® 15), and test time is also reduced to just 4.5 minutes (6-7 minutes when integrated to ambr® 15). Simple touchscreen operation, fast analysis time and automated quality control (QC) provide maximum simplicity, labor savings, and workflow efficiency for cell culture monitoring.

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Quality by Design – Develop your scalable design space

ambr® 15 cell culture

ambr® 15 cell culture mimics the characteristics of classical bioreactors at microscale (10-15mL) by using cost-effective, disposable micro bioreactors controlled by an automated workstation. The system enables the rapid evaluation of different clones at microscale, thereby increasing your speed to clinic.

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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.

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