Sustainability Report 2013 Lek d.d.

Sustainability Report 2013 – Lek d.d. Environment 44 Katarina Rajapakse, PhD., Biological Safety Officer at Lek d.d. The first Lek independent biological safety officer, Katarina Rajapakse Biological agents are the basis of our development and drug production In 2013, you became Lek’s first independent Biological Safety Officer. Have the requirements with regard to biological safety in Slovenia changed in recent years? Biological safety in Slovenia has been regulated since 2002, and two years later regulation came into force for persons responsible for biological safety in companies. At Lek, a Sandoz company, the independence of the position and the field of biological safety became inevi- table due to a rapid development of the Biopharmaceu- ticals unit. The unit has been operating since 2002 at the Menge‰ site, where the development, manufacture and analyses of biological substances are carried out. Within Biopharmaceuticals, as many as 8 out of 10 of Lek’s closed system for work with genetically modified organisms have been registered so far. The production facility PORT1 is one of them, the others are all labo- ratories. In these closed systems the development, op- timization, pilot processes and analyses of genetically modified cell lines and their products are carried out. The system of biological safety provides us with the ne- cessary infrastructure and decision-making processes with regard to human and environmental safety when handling biological materials. My primary tasks are to raise the awareness of associates about safe work and offer help in understanding the basic principles of biological safety when handling biological materials. Preventative action is also of key importance here. Which other areas of expertise does Lek’s Biological Safety Officer cover? I am responsible for following new developments and information about potential risks of working with re- combinant technologies. I advise in the preparation of risk assessments and other documents with regard to biological safety, such as contingency plans in the event of an accident or incident when using recom- binant technologies. I co-create written guidelines for working with biological material in a closed system and ensure that the associates who come in contact with biological material are sufficiently qualified. I re- gularly check containment measures and equipment and report to laboratory heads about identified pro- blems or faults. I am accountable for the cooperation with the regional information center and for informing the public about using recombinant technologies. There are also exter- nal inspections and internal audits, communication with the Ministry of Agriculture and Environment which is responsible for approval of the use of GMOs, as well as reporting, registration and modifications to closed systems for work with GMOs. Which of Lek’s processes require the need for concern for biological safety? At Lek, a Sandoz company, in the development and drug manufacture we almost exclusively make use of the classical biotechnological production of substances the basis of which are biological factors. Microorganisms in bioreactors produce antibiotics, they biotransform mo- lecules and form many secondary metabolites, called active ingredients. The increase in the efficiency of strains can be significantly influenced by optimizing the conditions, for example nutrients, temperature and pH, by the use of recombinant technologies and selection of strains, and by purification processes, we influence the yield of the produced active ingredient. All these activities require measures to prevent infec- tions, allergies or intoxication of workers and the release of biological agents in the environment. With the establishment of Biopharmaceuticals, Lek has entered an area of new-generation medicines also known as modern recombinant biological drugs. Biologicals in comparison with conventional medicines have practically no side effects and are extremely effec- tive. All the manufacture processes for recombinant biologics that include live cells, i.e. the development of mammal cell lines, the use of recombinant technology and production are inevitably included in the biological safety system. How does the experience that you have gained in re- search work help you? Ten years of research in biomedicine and biotech- nology at home and abroad gave me a broadness and oversight of a number of techniques, their weak- nesses or alternative approaches which are used in Lek’s closed systems. The laboratory is a very homely and familiar environment for me. This enables me to understand and be able to ask researchers the right questions when it is necessary to evaluate the working process and anticipate potential hazards and possibili- ties of exposure to biological material. And on this basis I also propose and adopt effective measures for the safety of our associates.