mAb Production

Production and Purification of Monoclonal Antibodies and Complex Molecules

Monoclonal antibodies (mAb) are the fastest-growing sector in the biopharmaceutical industry. Advances in genetic engineering and cell culture technology have led to dramatic improvements in the expression rates of recombinant proteins and therefore in the productivity of the (upstream) production process.

The production processes run in multiple stages, from low-volume seed cultures via intermediate cultures up to the production cultures in 25 m³ bioreactors.

The high titres from the bioprocess usually require highly efficient and robust purification and downstream processes (DSP). In industrial processing of bioprocess products, the downstream processing is often done on universal DSP platforms for purification of different proteins of the same class.

As well as a variety of filtration and virus-inactivation steps, the downstream process usually involves two or three chromatographic steps using contrasting separation principles.

In recent decades, cell cultures have become one of the most important tools in genetics as well as in research in cell biology, virology, immunology and oncology. They are a key tool for the development and approval of new medicines and for production of artificial tissues and therefore they are an important basis for industrial biotechnology in research and production.

 

ZETA designs and supplies systems for production of monoclonal antibodies. ZETA also designs and builds systems for the related production processes such as preparation of media, harvesting systems and cleaning systems.

Our bioreactor systems consist of bioreactors with specially designed equipment for mixing, gassing and releasing exhaust gas, and adding media, with fully automated sensor and control technology controlled by user-friendly software.

ZETA's product range also includes integrated harvesting systems, separators and filters as well as equipment for chromatographic purification steps.

All components are designed to be compatible with one another and meet current GMP standards for both the physical equipment and the automation.

 

ZETA also offers support in developing robust and efficient industrial biopharmaceutical production processes and in establishing these processes in routine production. In our process development work we determine the optimum operating conditions for each individual process step. A statistically-based design of experiments and optimised analytical strategies support efficient screening of the best bioreactor processes and the parameters for purification of the active ingredients.

Using these technologies contributes to better understanding of the process and enables us to define the ‘design space’ – an essential step in the Quality by Design approach to development of robust and validated production platforms.

For low-loss and high-quality storage of intermediate products or final products, ZETA offers a special product family. It includes:

The ZETA Advantage

ZETA supplies:

  • Production processes for monoclonal antibodies
  • Process optimisation in upstream and downstream processes
  • Product safety (virus safety)
  • Scale-up
  • Technology transfers (in-house/external)
  • Storage/freezing of large molecules
  • GMP compliance
 
 
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