Bosch has introduced a new pilot fermenter for the cultivation of active pharmaceutical ingredients (APIs) on laboratory and pilot scale.
The fermenter system has been designed with a goal to create optimal conditions for the growth of microorganisms such as cells and bacteria.
At the same time, the system also needs to meet cGMP regulation standards of the pharmaceutical industry.
The new fermenter system is claimed to fulfill the requirements for the production of APIs and for a range of applications. It comes in different batch sizes ranging from eight or 13 litres and up to 50 litres.
Besides this, the size of the reactor can also vary from sizes between 100 and 200 litres and are available for pilot and small industrial batches.
With this product, the company is complementing its already existing portfolio of fermentation devices which offered volume production ranging between 500 to 5,000 litres.
Bosch subsidiary Pharmatec sales director John Medina said: “In the pharmaceutical industry, the manufacture of complex compounds using biotechnological methods continues to grow in importance. Whether the desired substance is an insulin preparation or a medication for targeted cancer therapy – our bioprocessing systems deliver optimum product quality and excellent process results.
“With the new pilot fermenter, Bosch has rolled out a modular, fully automatic system that is suitable for R&D applications, clinical studies in the lab, and industrial production of small batches.”
The new fermenter has been designed to be equipped with one of several interchangeable mixing elements that are designed for different cell types and process controls. The mixer can regulate the inflow of liquids or gases used in the cultivation of the cells.
The fermenter can also use gentler technologies like air lift module for sensitive cells and for robust cells, the machine has mechanical stirring capabilities.
There is a fully automatic feeding of process media in place. As an alternative to installed peristaltic pumps and two additional pumps in the periphery, Bosch included a separate module that can offer high-precision dosing for liquid media with four syringe pumps.
This can be expanded to add additional peristaltic pumps so that additional process fluids can be dosed.
The fermenter has a gentle rotary pump and a second reactor vessel and it supports batch and fed-batch processes, along with perfusion and continuous processing.
The fermenter system has been built as a package unit and the integrated wall can separate technical section from operational area. The system allows for easy cleaning and sterilisation (CIP/SIP).
It has a steam generator, exhaust air cooler and heating/ cooling device for the bioreactor. Given the tasks and requirements, up to four interchangeable process sensors are available. Bosch claims that this concept can enable quick installation at available spaces with limited media availability and quick changeover.
Image: Bosch showcases new fermenter for APIs. Photo: Courtesy of Robert Bosch GmbH.