Fetal Bovine Serum Rebranding Steps and Cell Culture Stability Validation

I. Information collection and risk prediction before replacement

The first step in the fetal bovine serum brand change step is not a direct replacement, but a systematic comparison of the existing culture system and the candidate brand.The laboratory should record the current serum brand, batch, endotoxin level, hemoglobin content, protein concentration and other common quality control indicators, and clarify the sensitivity of the cell line to serum.For adherent cells, primary cells, or key cells for production/testing, it is recommended to list the replacement risk as a moderate or higher change and develop a validation plan in advance.

II. Small Batch Samples and Basic Physical and Chemical Evaluation

Before the formal switch, you can apply to the supplier for a small package sample and check whether the accompanying quality documents are complete, including the certificate of origin, quarantine certificate, sterility test report, etc.Generally, new brand serum is required to have a clear appearance and no abnormal precipitation. pH, osmotic pressure, endotoxin and other indicators are within the common specifications of this product.

Confirm whether the serum source and production process are stable;

Observe for flocculation or turbidity after thawing;

Record the batch number and expiration date to avoid mixing different batches.

III. Cell Adaptability Pretest

Select 1-2 representative cells for pre-test, set old brand serum, new brand serum, and mixed serum group.During the culture process, the cell adhesion rate, morphology, doubling time, and survival rate were observed.If the cells are sensitive to serum changes, a gradient replacement method can be used, such as mixing the old and new serums in a certain proportion and gradually transitioning.In the whole fetal bovine serum replacement branding step, pre-testing is the key to judging compatibility.