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Production of Antibodies and Hormones

Flexible solutions for all stages of development

Rising time and cost pressures make the development and manufacturing of therapeutic proteins challenging. Antibodies dominate the biopharmaceutical market and their production is widely established. Alternative technologies like the recombinant production of antibody fragments and nanobodies, however, keep the research field exciting. Improved cultivation techniques such as perfusion and new possibilities in data handling and automation offer companies the chance to set themselves apart from the competition.

Monoclonal antibody production

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. Process development efforts include optimization of media and feeding strategy, process control, and scale up.
Optimizing a Biosimilar Production Process

Process development in cell culture

The production of complex biomedical proteins represents one of the primary applications in animal cell culture. The requirements of different cell lines may vary heavily resulting in the challenge of finding optimum settings for temperature and pH, gassing rates as well as nutrient composition as they influence cell growth and product titers.

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.

The Morbidelli group at ETH Zurich uses a DASGIP® Parallel Bioreactor System for process optimization in various projects, from scale-up studies and development of a perfusion process to the cultivation of stem cells .Vania Bertrand, PhD candidate at the ETH Zurich, was interviewed about her work in the Morbelli group and her private life.

Process automation and data analysis

The integration of external analysis data into running production processes has attained major importance over the past few years, pushed by the FDA’s process analytical technology (PAT) initiative. In addition, Multivariate Data Analysis (MVA) and Design of Experiments (DoE) are advanced techniques which enable bioprocess laboratories to improve their data and ultimately accelerate biopharmaceutical development, reduce costs and shorten the time to market.

Watch webinar: Automated bioreactor sampling and glucose control

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.

Process automation and data analysis

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.