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Monoclonal antibody production
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Flexible solutions for all stages of development
Since the 1980s, production of monoclonal antibodies (mAbs) using hybridoma cells has been accepted as an effective technology for cancer treatment. Meanwhile, mAbs make more than half of the total biopharmaceutical market. In antibody production, many factors have to be taken into account before entering the manufacturing stage.
Eppendorf bioprocess solutions support the upstream bioprocessing cycle from early development to scale-up to pilot-scale production. Powerful hardware and software tools help to build process understanding, implement control strategies, and streamline process scale-up.

Bioprocess development in cell culture
Eppendorf offers parallel bioprocess systems at small and bench scale. They allow multiple experimental parameters to be tested simultaneously in one run, which ensures maximum comparability between runs and saves time and resources.
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Bioprocess scale-up and technology transfer
Eppendorf offers scalable bioreactor systems for seamless bioprocess scale-up from R&D labs to pilot and manufacturing facilities. A wide selection of single-use bioreactors complements the portfolio of glass and stainless-steel vessels.
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To streamline scale-up, bioengineers commonly use bioreactors with similar geometries at all scales and keep one or more parameters constant between vessels of different sizes, such as kLa, power input per liquid volume or tip speed.
The Scale Up Assist feature of the BioFlo 320 and BioFlo 720 simplifies scale-up strategy design, by considering vessel parameters of differently sized Eppendorf BioBLU® Single-Use Bioreactors and Thermo Scientific™ HyPerforma™ Single-Use Bioreactors.
Get to know, how the Scale Up Assist simplified scaling-up mAB production in CHO cell cultures from bench to pilot-scale.

Streamlining the transfer of an upstream bioprocess from research to production scale is critical for reducing biologics development costs and time to market. Winston Wong (Eppendorf Americas), Klaus Ferber (Eppendorf AG), Ben Asher (Thermo Fisher Scientific) and John Shyu (Corning Life Sciences) share their thoughts on scale-up challenges from an economical, operational, and application-related point of view.

Perfusion
Increasing the efficiency of production processes is one of the major tasks biopharmaceutical manufacturers are facing nowadays. Continuous processing and perfusion cultivation are techniques to increase cell density and product titers while leading to smaller production volumes.
Eppendorf offers Fibra-Cel® Disks , a three-dimensional growth matrix to support perfusion without the need for cell filtration. Alternatively, the integration of cell retention devices with Eppendorf bioprocess systems facilitates perfusion based on tangential flow filtration.
- Download publication: Culture methods in mAb production
- Download application: Perfusion in CHO cell culture

Process analytical technology and bioprocess automation
The integration of external data analysis into running production processes has attained major importance over the past years, pushed by the FDA`s process analytical technology (PAT) initiative. Inline analysis of process parameters helps to gain process understanding and facilitates automated process control. Eppendorf bioprocess control software allows the integration of many external devices and the implementation of automated feedback control loops based on sensor readings.
- Watch webinar: Increasing upstream bioprocessing efficiency through process analytical technology
- Download eBook: QbD and PAT in biopharmaceutical development

The Applied Process Company (APC) integrated external PAT and an APC-developed controller with an Eppendorf DASGIP Parallel Bioreactor System. Online PAT measurement and control of critical process parameters led to greater understanding and the streamlined optimization of the bioprocess.
“The ability of the DASGIP system to integrate both the external PAT and in-house developed controllers was vital to the success of our application.”, comments Dr. Stephen Craven, Life Science Team Leader at APC.
- Download publication: A QbD approach to bioprocess intensification
- Download interview with Jessica Whelan

Scientists at CEVEC Pharmaceuticals® performed a successful scale-down of their established process to 170 mL working volume using a DASbox® Mini Bioreactor System with BioBLU® 0.3c Single-Use Vessels.

At the University of Delaware , Babatunde A. Ogunnaike and his team have established the foundation for effective real-time online control of glycosylation patterns on monoclonal antibodies produced with Chinese Hamster Ovary (CHO) cells. For establishing base regulatory control of key process variables known to effect glycosylation, they set up a bioprocess with nutrient control and cellular metabolite monitoring through integration of an external analyzer.

Integration of a DASGIP® GA4 exhaust analyzer facilitated automated feeding of a Pichia culture based on keeping constant the respiratory quotient (RQ). Feeding optimization was automatically self-achieved as the culture created its own demand for feeding based on the drop of the RQ-value.

A selection of our customers
Eppendorf SE
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