Every batch of biological medicine produced by a manufacturer must undergo rigorous and independent testing before it can be released on to the market for human use. The results for every batch must be consistent with those which were previously shown to be safe and effective in clinical trials or routine clinical use.
Batch release testing of biological materials dates back to the Therapeutic Substances Act in 1925, thus the testing we do today is underpinned by almost a century of experience and knowledge. The National Institute for Biological Standards and Control (NIBSC) was established in 1972 and as an Institute, we have been safeguarding the quality of biological medicines for almost 50 years. Our staff of approximately 300 scientists has a wealth of expertise and experience in regulatory science.
Every batch of biological medicine submitted to the NIBSC for testing faces the same high level of scrutiny from our dedicated scientific team to ensure that each dose administered is safe and effective.
Independent assurance of quality
Although manufacturers carry out their own comprehensive testing regimes on the batches of medicines they produce, tests focused on safety and effectiveness are also conducted independently. This testing is carried out by National Control Laboratories. These are government bodies that work within a system that has defined standards of quality to ensure the accuracy of laboratory results.
The NIBSC acts as the UK’s official National Control Laboratory. Our independence on testing means that public health is at the forefront of all decisions related to the quality of batches of biological medicines.
Why batch release testing is necessary
Biological medicines like vaccines are derived from sources such as living cells or purified components of human blood. They are typically very complex in nature and this means that their production cannot be controlled in the way it can for chemical-based medicines like paracetamol. Because of this, biological medicines are subject to in-depth testing of the final product which is critical to ensure the quality of every batch that’s manufactured.
Tests for potency and safety
Batch release testing focuses on two aspects, potency and safety.
Potency refers to the functionality of the active ingredient and this can be measured using a variety of laboratory tests. For instance, measuring the amount of active ingredient present in a vaccine can indicate whether it will work or not. In addition to the amount present, the shape of the active ingredient is also analysed to make sure it can be correctly identified by the human immune system.
In terms of safety, decades of experience have informed what needs to be measured. For example, medicines derived from blood products are screened for the presence of contaminating viral material and toxins produced by some bacteria.
We engage with manufacturers from the early stages of development, to gain full insight into the nature of the medicine. This helps us to ensure that the most appropriate methods for measuring potency and safety aspects are in place for our independent testing.