How do you integrate risk assessment into biotechnology product development?

1 Principles of risk assessment

Risk assessment is the process of identifying, analyzing, and evaluating the possible adverse effects of a biotechnology product on human, animal, or environmental health. It involves four steps: hazard identification, hazard characterization, exposure assessment, and risk characterization. Hazard identification is the identification of the potential harmful effects of the product or its components. Hazard characterization is the estimation of the severity and probability of the harmful effects under different conditions. Exposure assessment is the estimation of the frequency, duration, and extent of contact with the product or its components. Risk characterization is the integration of the previous steps to estimate the overall level and uncertainty of risk.

2 Methods of risk assessment

When assessing the risks of biotechnology products, there are different methods to consider, depending on the type, purpose, and stage of the product. Qualitative risk assessment is a common method that uses descriptive terms like high, medium, or low to rank the risks. This is useful for screening, prioritizing, or communicating risks, though it may not be accurate enough for decision-making or regulation. Quantitative risk assessment uses numerical values to measure the risks and is useful for comparing, testing, or validating risks. However, it may require more resources and data. Lastly, semi-quantitative risk assessment combines qualitative and quantitative elements to assess the risks. This method is useful for balancing, weighting, or ranking risks; however, it may involve some arbitrariness in the scoring system.

3 Frameworks of risk assessment

Risk assessment for biotechnology products can vary depending on the context, scope, and objective of the assessment. Three common frameworks are risk analysis, risk-benefit analysis, and risk-societal analysis. Risk analysis involves assessing risks and implementing measures to reduce, control, or accept them. Risk-benefit analysis evaluates whether the benefits of a product outweigh its risks. Risk-societal analysis considers the societal implications of a product and how it affects values, norms, and interests of society. Risk analysis is often used for regulated products such as drugs or crops, while risk-benefit analysis is used for products intended for human or animal use such as vaccines or diagnostics. Risk-societal analysis is increasingly used for biotechnology products that raise social or ethical concerns.

4 Integration of risk assessment

Integrating risk assessment into biotechnology product development is not a one-time or isolated activity, but rather a continuous and iterative process that involves multiple stakeholders, disciplines, and stages. To ensure success, the risk assessment must be properly aligned with the product objectives, specifications, and requirements; adapted to the product characteristics, context, and uncertainties; evaluated for quality, validity, and reliability; communicated clearly and effectively to stakeholders; and receive feedback that is incorporated into the product development or improvement.

5 Examples of risk assessment

Illustrating how risk assessment can be integrated into biotechnology product development, here are some examples. For a new drug to treat cancer, the risk assessment follows the risk analysis framework and uses quantitative methods to estimate safety and efficacy in preclinical and clinical trials. It also considers quality, stability, and potential interactions with other drugs or substances. The results support regulatory approval and post-marketing surveillance. For a new diagnostic test for detecting COVID-19, the risk assessment follows the risk-benefit analysis framework and uses semi-quantitative methods to compare accuracy, sensitivity, specificity, cost, availability, and accessibility with other tests. The results inform decision-making and implementation. And for a new crop to enhance food security, the risk assessment follows the risk-societal analysis framework and uses qualitative methods to identify potential environmental and social effects. It also considers ethical, legal, and cultural aspects of the crop as well as potential conflicts or trade-offs with other values or interests. The results engage stakeholders and the public to address social or ethical issues of the crop.

6 Here’s what else to consider

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