The production department Biotech Operations (BTO) is the spill of Centocor. Here we proudly produce, according to the cGMP regulations, our products. The culture in BTO is open and respectful, the environment in which we work is high-tech. We are in constant tough with our colleagues in the United States and Ireland.
The production process is carried out in seven departments:
- Fermentation where the product is produced in fermentors;
- Primary Recovery where the first purification of product is done;
- Downstream Processing where the final purification of product is done;
- Medium Preparation where growth medium for the fermentor is made;
- Buffer Preparation where solutions and buffers are made for the purification steps;
- Equipment Preparation where equipment, needed for production, is washed, assembled and autoclaved;
- Production Environmental Services who take care of cleaning of the production environment.
Shift teams carry out the production process, with the support of the dayshift – BTO office – giving administrative support, and the Center of Expertise.
The Center of Expertise, as process and equipment owner, sees to it that all preconditions are at hand to allow production. This way, the Fermentation assembly team delivers fermentors to production; the Preculture team grows cells used in Fermentation; and the Column Packing team sees to it that there are always sufficient packed columns for the production process. Furthermore, the Center of Expertise delivers, amongst others, the knowledge for the practical translation of development work to clinical and commercial production, works on a safer and more efficient production and offers support in the area of cGMP regulations.
Within the BTO departments we have several positions – from technician, team leader, engineer, supervisor, manager to director. Together we are responsible for the production, as well as for improvement projects in the area of safety, cGMP and (cost) efficiency. For improvements methods as Lean Manufacturing, Six Sigma and Design Excellence are in place.
