A second level of changes that have a slightly higher chance of affecting the final product must be reported to FDA 30 days before implementation, but they do not require preapproval. Changes that are known to have a high probability of affecting the final product still require the submission of data and approval from FDA before being put in place. In the early days of the biotechnology industry, analytical techniques did not allow detailed characterization of the end product. The process, therefore, was all important and strictly regulated. In recent years, however, advances in instrumentation have changed quality control in biotech companies and are slowly changing the way FDA regulates the processes.
Regulatory changes place more of the responsibility and accountability on biotech companies.
Garnick believes that knowing the structure of the molecule is not as important as understanding the structure-function relationships. Many of the biotechnology products are inherently heterogeneous, making it unlikely that there will be only a single species to be characterized. For example, DNase, a phosphorylated glycoprotein, is a nonspecific endonuclease for which the carbohydrate serves no function for the biological activity. In contrast, in the case of EPO, the carbohydrate plays an important role, and it becomes more important to be able to characterize that portion of the molecule. In the past, immunoassays were an important part of quality control in biotech companies.