The procedures involved in antibiotics manufacturing depend on whether a product is natural, semi-synthetic, or fully synthetic. Natural drugs are made by cultivating microorganisms in controlled conditions and collecting the compounds they express, while semi-synthetic products involve an additional step to modify naturally produced chemicals. Synthetics, like sulfa drugs, are made with a chemical manufacturing process. The production of antibiotics in all cases requires a sterile environment with constant monitoring to check for signs of contamination that might interfere with the safe production of medications.
Natural antibiotics require the preparation of a culture of microorganisms, like fungi, that express antibiotics as a side product. They are grown in large fermentation tanks with food to keep them reproducing. A microbiologist supervises the process, controlling the temperature, humidity, and other conditions to increase the yield. It can take several days to prepare an antibiotic broth that needs to be run through filtration systems to purify and extract the drug. Testing assures personnel that the production of antibiotics was not contaminated, and the medication is sufficiently strong to be sold to the public.
Semi-synthetic drugs add a step to to this. Instead of purifying and packaging the natural product, the staff at the manufacturing facility treat it with a chemical process. This step in the production of antibiotics modifies the structure of the drug. It is not fully synthetic, because it’s based on a natural product, but it isn’t the same product as that which might be found in the wild. These drugs may be more virulent against a broader range of organisms, or could have fewer side effects than their natural forms. Ampicillin is an example of a semi-synthetic antibiotic.
Synthetic drugs are made with chemical reactions, starting with a feedstock that is modified in a controlled environment. The production of antibiotics through synthetic processes can be easier to control, because it is not subject to the natural variations of the living organisms used in fermentation tanks. It still requires careful monitoring to check for contamination and produce drugs that are pure and of standard concentration.
As with other pharmaceuticals, the production of antibiotics is subject to regulation by the government. Agencies can inspect production facilities and batches of products with the power to recall drugs if there are concerns about safety or efficacy. They may also request logs documenting testing and quality control procedures, to confirm that the company has clear internal standards and follows them at all times.