Dr Lucky S. Slamet, Indonesia

One of the advantages of biotechnology, including DNA technology, is that it allows the production of large quantities of therapeutic products that are difficult to prepare from natural sources using a conventional approach, or that are otherwise unavailable. The development implies a potentially limitless supply of drugs and vaccines.

Biotechnology products are probably the best purified and characterized biological medicines in clinical use. Their nature and production are highly sophisticated and must comply with international guidelines on standardization and control. However, the quality, efficacy and safety of such biological medicines in humans still needs to ensured through regulation, such as premarketing approval and licensing, and postmarketing inspection. Considerable emphasis must also be given to “in-process” controls on the starting material and the manufacturing process, as much as to the analysis of the final product. Data are needed on quality and purity of cell culture and on the effectiveness of purification and test methods. Furthermore, the ability of the purification process to remove unwanted materials, such as DNA and potential viral contamination, must also be validated.

The existing international guidelines on the production and control of biotechnology products have helped the Indonesian authority to regulate these products before and after marketing. Regulation covers the critical functions needed to ensure the quality of biologicals, i.e., a published set of requirements for licensing, surveillance, system of lot release, laboratory testing, regular inspection for GMP, and evaluation of clinical performance.

For licensing, the basic criteria for evaluation cover the main aspects of safety, efficacy, relevance to actual needs, quality, and compliance with GMP. Confirmation of safety and efficacy is based on review of preclinical and clinical data. For quality, evaluation covers control of the manufacturing process, from starting materials to final product. However, with the increased production capacity for biotechnology products, not only in developed but also in developing countries, regulatory measures as well as the authority’s scientific capacity for premarketing evaluation needs to be strengthened, including the capacity to oversee clinical trials, ensure compliance with GMP, and carry out postmarket quality assurance and safety monitoring of such products.