In clinical research, every product submitted for approval for human use must be rigorously tested and approved before release onto the market. This can be a costly process.
Batch testing is an economical way to test several items at once in a laboratory, rather than individually. It is also a way to maintain quality control when testing new medicinal products for human use, to ensure only the highest standard of medicines are approved for market sale.
This form of group testing is common in pharmaceutical research as it can be used to review the overall reaction to a test, which makes the results more accurate. Batch testing is also known as pool testing, as it tests a pool of samples.
One of the main advantages of batch testing is that it reduces costs. One set of testing materials can be used to test a batch of several samples, which is less expensive than testing each sample separately.
If the result of a group of samples is positive it indicates each does not have to be tested separately, which is time-consuming and costly. An additional cost saving can be gained by using data from previous batch testing samples.
Batch testing can deliver more reliable generic results than if a sample is tested individually as the mathematic base is greater.
Batch testing is a form of quality control. The more samples that are tested the more accurate the results are likely to be. When submitted for approval a new drug, medicine, or product is likely to have been submitted in a batch.
Drug quality is essential when used on humans. A drug must be approved as entirely safe before it can be marketed.
Batch testing is common with vaccines, for example, it was used in the development of the COVID-19 vaccines. This is because a vaccine often contains parts of other viruses, and these behave very differently from medicines that are chemically based.
In drug development sometimes batches are tested in comparison to previous samples. These must be entirely consistent to ensure standards are maintained.
The EEA (European Economic Area) has specific guidelines for batch testing as does the FDA (the US Food and Drug Administration). These guidelines ensure that batch testing is consistent and follows strict regulations. A batch of a medicinal product or new drug has to be formally approved before it can be marketed and must meet the government regulatory standards.
Every sample has to contain the same amount of testing material in an equal composition. The batch must be clearly labeled so it is not mixed up with any other samples.
Batch testing reviews the strength of medication and how the active ingredient reacts when subjected to certain tests. For example, before a new vaccine can be approved and marketed, the human body’s reaction to it must be understood. This ensures the ultimate safety standards for any new medicines.
Batch testing can be carried out by a pharmaceutical company, or it can be given to an independent research center for analysis, which must be authorized for testing. Some companies test in-house and externally to double-check the safety of medicines.
The testing material for a batch is more diluted than for an individual sample, which means that the proportions must be accurate. If a sample is diluted the results may not be accurate.
Clear records must be made of the date of the testing and the documentation should be reviewed by a qualified person. This is not a regulation, but an essential part of good laboratory practice. Sometimes the results of a batch test indicate that the batch has to be re-tested – which is a further quality control procedure.
At Biobide hundreds of compounds per year are handled to prove the efficacy or the toxicity of new molecular entities using our zebrafish platform. Many reference compounds are also used in these studies and batch testing and Certificate of Analysis (CoA) is a requirement to know the quality and purity of these compounds.
In summary, what is batch testing? Batch testing is a cost-effective quality control method that can help bring new drugs to market faster. In an environment where limited drugs are approved and released every year, batch testing is a distinct advantage for medical research.