Biosafety Committee - BioInn
Biosafety can be defined as the set of measures (organization, work practices, design of facilities, safety equipment, etc.) aimed at preventing and protecting human, animal, plant and environmental health against all agents, factors and risks of biological origin.
Behind this concept there is a wide and diversified set of regulations aimed at the protection of living beings and the environment that regulate aspects such as: export and import, release into the environment, contained use, production, transport, marketing, storage and destruction or disposal of biological agents, whether genetically modified or not. The main objective is to ensure effective prevention and protection of human health, agricultural production, biological diversity and the environment.
In response to the need to regulate and improve biological risk management, the Biosafety Committee of the Biomedical Innovation Unit and its regulations were created.
Biosafety Committee Composition
President:
Guillermo Güenechea Amurrio (Division of Innovative Hematopoietic Therapies. CIEMAT). PhD in Biological Sciences. Principal researcher at CIEMAT and head of the Telomeropathies Unit.
Secretary:
María Luz Lozano Vinagre (Division of Innovative Hematopoietic Therapies. CIEMAT). Specialist laboratory technician. Head of Quality of the GMP laboratory (CliniStem) and of the viral vector production laboratory.
Members:
Begoña Díez Cabezas (Division of Innovative Hematopoietic Therapies. CIEMAT). PhD in Cell Biology and Genetics. Responsible for Good Laboratory Practices (GLP).
Nuria Illera Esteban (Epithelial Biomedicine Division. CIEMAT). Specialist laboratory technician. Responsible for humanized animal models with epithelial cells.
Lucía Morales Rodríguez (Molecular Oncology Division. CIEMAT). PhD in Molecular Biosciences. Researcher and head of cell culture.
Oscar Quintana Bustamante (Cell Technology Division, CIEMAT). PhD in Molecular Biology. Researcher and head of humanized animal models with hematopoietic cells.
Responsibilities
The General Director is ultimately responsible for biosafety and exercises this responsibility through delegation to the established line of authority and, more specifically, to departmental management, research staff, supervisors and, ultimately, to each of our center's employees.
The personnel that may be involved in biosafety activities and their specific functions and responsibilities are detailed below:
- The principal investigator (PI) of each project or line of research is responsible for the safety and health of all personnel involved in their project.
- The supervisory personnel, as the main person responsible for the facility, has the authority and support necessary to assess risks, establish safety policies and procedures, ensure adequate training of research personnel and proper maintenance of the facility and equipment.
- The biosafety consultant (CBS) is responsible for advising on the handling of biological agents and for overall management of the biosafety program.
- The technical staff.
Operation
What do we do?
The main functions of the CBS are:
- Advise, review and approve protocols, work regulations and risk assessments in relation to biological agents and genetically modified organisms (GMOs).
- Evaluate, in advance and periodically, the adequacy of the facilities, measures and procedures adopted for the handling, transportation and disposal of these agents.
- Communicate the use of these agents to the competent authorities.
How?
At CBS we work to ensure that both research and teaching practice that requires the use of biological agents or GMOs are carried out in accordance with legal safety regulations. Therefore, it is necessary that researchers notify the CBS of any procedure or protocol they wish to develop with these agents, following the diagram below:
When?
Regular meetings will be held at least twice a year. After receiving any procedure or project that requires advice or evaluation by the CBS, it will be processed internally and if necessary, an extraordinary meeting will be called to propose modifications and issue authorization.
Where?
CIEMAT currently has research laboratories and an animal facility for the health field.
- Culture Laboratories (2 culture rooms and 16 type 2 biosafety hoods), NCB2.
- GMP CliniStem Laboratory (room for ATMPs production), NCB2.
- Viral Vector Production Laboratory (1 culture room and 3 type 2 biosafety hoods), NCB2+.
- Molecular Biology Laboratories, NCB1
- Flow Cytometry Laboratories (LACISEP), NCB1
- Histology and Cytology Laboratories, NCB1
- Animal Facility and Biomodule, NCB1 and NCB2
Why?
At CBS we want to contribute to the development of policies and codes of good practice related to biohazard: we protect your health and everyone's!
- What to do in case of an accident in the laboratory
- Internal rules for culture rooms
- Level 2 and 2+ laboratory safety standards
- What to do in case of an accident involving biological agents
Forms
Biological agents Lentiviral vectors Adeno-associated vectors
safety data sheet safety data sheet safety data sheet
