Health & Safety in iGEM

In iGEM, our main priority is the safety and wellbeing of us as a team and of those working around us, without a doubt being the most important aspect to our project. We ensured that our first step was the organising of a Lab Safety session with our ACBE Lab technicians to ensure we are aware of all the dangers around us, especially those linked to our project.

1.Would any of your project ideas raise safety issues in terms of:

Research

In terms of research and wet lab, Xiang compiled a vital Do and Do Not list 10 Steps to a safer lab session. The majority of chemicals that were used did not pose a significant risk to us, the only real one was the use of ethidium bromide whilst carrying out gel electrophoresis, and one must be aware that it is a cancer inducing chemical. This meant special gloves had to be worn for extra protection.

Other well known safety measures were the wearing of goggles and lab coats at all times when in the laboratory and fermentation hall. One vital point was never to leave a person alone in the lab, and to always have atleast two people in the lab at all times.

A deeper approach was adopted by attending a safety training run by the Department of Biochemical Engineering at University College London, in order to know "the code of practice".

An initial Hazard identification and assessment was carried as a first step, which included the identification of any compound-from ionised water, to buffers, to GMOs (Genetically Modified Organisms) and the assessment of the risk they imposed upon human health.

The critically of Health & Safety, under the Health & Safety at Work Act 1974, was emphasised and bear in mind at all times, as this is "the alpha and the omega" meaning that any professional research should be carried under the regulations published by the relevant regulatory bodies, for the health and safety of the researchers. HSE, the Health and Safety Executive in UK, is the main regulatory body providing the relevant advice and support for any industrial business. With regards to our case, we made quite a breadth and depth research into the policy surrounding the operation of a pharmaceutical industry plant and summarised some key points:

Process Validation Process validation allows understanding and control of the process, equipment and facility.

QC testing After the process is validated, each batch is then validated via QC testing for Purity, potency and sterility

GMP, GLP and GCP compliance A biopharmaceutical facility must comply with the GMP, GLP, GCP requirements: General Manufacturing/Laboratory/Clinical Practices respectively, by the FDA (Food and Drug Administration)

Design Qualification of equipment (DQ) Installation Qualification of systems (IQ) Operational Qualification (OQ) Process Qualification (PQ)

Accident Prevention Policy & Emergency plans Emergency procedures must be in place e.g. In case of a fire: according to the 1910(29 CFR) Subpart E (OSHA) Occupational Safety and Health Administration of the United States: Exit routes, emergency evacuation plans, first aid facilities, breathing apparatus and of course trained personnel.

Staff training For example, operators risk injury from lifting and handling heavy machinery or from repetitive strain problems. This is very important, as taking breaks as often as required from daunting tasks, is within the employee's rights.

Hazard identification and assessment provide a table with few examples

Documentation SOP: Standard operating procedure, BMR: batch manufacturing record, records of process data and monitoring data.

Mechanical Integrity Critical when operating highly pressurised equipment such as a highly packed chromatography column, a centrifuge or other unit operations. Regular checking and maintenance is required.

Waste Management Waste handling is a way of improving efficiency on the production plan as well as maximizing profits. Protein aggregation, contaminants, toxins, host cell proteins, cell debris, lipids and other by-products liquid/solid/gas must be identified and follow the suitable pre-treatment route.

Public

Having done the research, it has become quite evident that our product poses no extra risk compared to any other ordinary biopharmaceutical process to the public. If anything, not using IPTG and using such a genetic circuit will result in a much more efficient process in the expression of the protein. But nevertheless,

Environment

The main purpose at this stage is the proof of principle, to show that YES this is something that can be applied to so many other processes in different industries and different disciplines. That is the dream. And that's why ....

The lack of use of IPTG will mean .............

2. Do any of the new BioBrick parts (or devices) that you made this year raise any safety issues?

Our new Biobrick contains parts that are well established and documented in the biopharmaceutical industry, and so there is very little risk to the consumer. But more importantly, any risk say in terms of the production of maybe side effects or the reminants of such biobricks which may have adverse effects will be dealt with in the downstream processing where they will removed using multiple filtration utilities.