Biotechnology products safety issues

Several years ago an ICH guidance (ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals) was written to address the preclinical development and safety issues of products derived from biotechnology. ICH S6 defined biotechnology-derived pharmaceuticals as products derived... 

Yet just as all people are not alike, neither are all food crises alike. They can vary in their familiarity, severity, proximity, consequence, and the extent to which they can be avoided. This review covers a wide range of crises from bacteria contamination, to product tampering, to fears related to irradiation and biotechnology. Different types of crises will be evaluated differently by different groups of consumers. What has been done in this review is to focus on worst-case scenarios involving initial responses to food safety issues. These will provide the most clear and illustrative profiles of consumer response. Less extreme scenarios will elicit less extreme responses. 

Preclinical and safety issues are discussed in cooperation with the biotechnology working party. A guide with regard to the quality and preclinical and clinical aspects of gene transfer products has recently been produced. 

In the early days of biotechnology product development, the focus was on quality issues [4] or process-related impurities.The concerns at that time were for carryover of other cellular proteins and DNA and for contamination with endotoxins, chemicals, and viruses. Of course, these concerns still exist, but methods for purification and assays for evaluation of clearance have alleviated the need for the safety assessment scientist to focus on contaminants instead they are now asked to focus on the pharmacological activity of the molecules. An ICH guidance (Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) addresses the specific issues related to the manufacturing process [6], Other product-related issues such as impurities do need to be considered by the safety assessment scientist, for... 

The EMEA has in place a Biotechnology Worldng Party that has considered, among other things, safety issues in the delivery of human somatic cell therapies and a definition of a ceU therapy medicinal product ... 

Biotechnologically-derived products are associated with unique but inherent safety issues which are specifically related to long-term pharmacological effects. Short-term preclinical trials may not adequately address these issues. In this chapter, the treatment of auto-immune disease is used to illustrate some of the problems encountered in the preclinical safety evaluation of biotechnologically-derived products. 

Griffiths SA, Ashton GA and Lumley CE (1995). Non-clinical Safety Testing of Products of Biotechnology Issues of Concern. CMR International Report, CMR95-63R, December 1995. 

The ICH S6 Step 2 draft guideline Note for Guidance on Safety Studies for Biotechnological Products adequately addresses the general principles involved in the safety evaluation of biotechnologically-derived pharmaceuticals. However, additional information is needed to address the issues imique to monoclonal antibodies (MAbs) for therapeutic use. These issues are listed in Table 14.1 and described in turn. 

The ICH guideline on preclinical safety evaluation of biotechnologically-derived pharmaceuticals has recently achieved Step 4 of the ICH process. This represents a success for harmonisation and it will be important to assess the impact of these guidelines on the development of biotechnology-derived pharmaceuticals. However, it will be necessary to continue to re-examine what new data may be necessary to assess the safety of biotechnologically-derived products and to identify new issues that need to be addressed. The CMR International workshop has made a significant contribution along these lines. 

Society is becoming progressively more worried with safety issues while wishing for a sustainable future. Sustainable chemistry represents an area of innovation, which not only preserves resources but also stands for a development process in the chemical industry. The most important goals in fine chemicals, skin care products and pharmaceuticals including biomedical compositions are the development of nontoxic and biodegradable compounds, the advance on new reaction conditions (cleaner solvents, biotechnological processes, etc.) and the use of raw materials from renewable feedstock [1]. 

In a similar approach to that taken by the FDA, the International Food Biotechnology Council (IFBC) addressed issues associated with food and flavor ingredient production from GM materials and concluded that a reasonable safety assessment could be made by determining whether the ingredient had a prior history of safe use in approved foods and, if so, whether the GM substance was... 

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