The smallest of inconsistencies can create significant issues in the lab for companies like Manchester Biogel, causing additional testing, delays, unusable output, and cost overruns. Here we take a look into why batch-to-batch consistency is essential to cell culture.
What is Batch-to-Batch Consistency?
Several target cells are identified, extracted, and incubated under conditions that are as similar as possible during a cell culture process. This allows the output to be tested and then confirmed through the discussion of the results of every sample, meaning higher volume material can be developed. If the conditions in which the cells were grown are not identical, the process will fail. The timing, incubation temperature, gases introduced, equipment used, nutrients, reagents, and growth matrix must all be the same for every test sample.
For cell culture to work, there must be a matrix that supports target cell growth by sustaining stable conditions, delivering the correct nutrient to the correct locations, and allowing the cells to remain fixed or migrate. One of the most common materials used in cell culture media is collagen as it provides optimum conditions in which cells develop. However, collagen sources can sometimes lead to conditions that are not identical, which is known as batch-to-batch inconsistency.
What Happens If Collagen Batches Are Inconsistent?
The cultures can become massively comprised if batch-to-batch consistency is not present. The culture matrix must be a stable variable that is controllable in research to allow other parts of the process to be investigated at the earliest date possible. The smallest of changes in the ionic concentration, incubation temperature, or pH level can determine the subsequent batches as unusable. The laboratory in cell production must also have the confidence that the culture matrix has not affected the output, and that the developed material will perform and is safe.
Regulatory compliance is another reason why batch-to-batch consistency is essential. External analysts will observe culture matrix samples and sources to decide the consistency during testing. If the laboratory finds this hard to demonstrate, they can find themselves facing a more significant administrative burden. Cell culture failure can occur from this, thus damaging reputation, laboratory costs, and throughput.
Guaranteeing Batch-to-Batch Consistency
The part to look at first is the storage and transportation of the collagen. The collagen culture matrix has to be at a low temperature so that integrity is maintained, and every sample has to be stored and transported together in a sufficient environment. Additionally, collagen must not be used after the date that the manufacturer sets and all other supplier-provided guidance must be followed to guarantee compliance. Every cell culture’s medium in a production run or single test should come from the exact same collagen supply in order to avoid any inconsistencies amongst deliveries.
Furthermore, sufficient guidance must be followed when sub-culturing cell lines. Sub-cultures will develop under different conditions if the culture matrix batches are not consistent. This would lead to much time being wasted when growing both the initial line itself and also its sub-cultures.
