<p>The article presents an analysis of the regulatory framework relating to biomedical cell products and high-tech drugs and reveals their similarities and differences. The validation parameters and criteria for their assessment were based on a study of the world scientific and regulatory literature. Data from a validation study of an alternative microbiological method for detecting carbon dioxide in a nutrient medium for analyzing the sterility of high-tech drugs were presented and their applicability was proven. It has been confirmed that 0.5 ml of the test sample followed by incubation for 7 days was necessary and sufficient to obtain reliable results and isolate microorganisms, including those with slow growth (<i>Cutibacterium acnes</i>), using an alternative method for testing high-tech drugs. The Mann–Whitney <i>U</i>-test showed no statistically significant differences between the results of validation studies obtained in 2017 for biomedical cell products and in 2024 for high-tech drugs.</p>