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Biological products are pharmaceuticals derived from microorganisms, cells, animal tissues, and fluids through biotechnological processes for the prevention, treatment, and diagnosis of human diseases. These products encompass preventive biological products (bacterial and viral vaccines), therapeutic biological products (antitoxins, antisera, blood products, and biotechnology products), in vivo diagnostic products, and in vitro diagnostic products[1].
To prevent bacterial contamination during strain development, drug screening, and manufacturing processes, some antibiotics are added to biological products. For example, the basic process for preparing the raw materials of biological products shown in Figure 1. However, there is a risk of residual antibiotics that may not be fully eliminated, posing potential harm to the human body. For instance, erythromycin residuals which are added to preventive biological products can cause hearing loss and peripheral neuropathy, while gentamicin can induce allergies and neurotoxicity in infants and young children. Vaccines containing antibiotics list antibiotic allergies as contraindications. Therapeutic biological products, like recombinant proteins and monoclonal antibodies, often include antibiotics such as ampicillin, kanamycin, and tetracycline, which may result in allergic reactions, ototoxicity, or nephrotoxicity.
Figure 1 Schematic of the basic process for preparing raw materials
The concern of antibiotic residues in biological products has garnered significant attention from governments and drug safety regulatory agencies globally. Numerous countries have established clear regulations such as USP, EP, mandating stringent control over antibiotic usage in biological product manufacturing processes, as well as stipulating testing standards for residue levels. Antibiotic usage should be minimized in the production process. Antibiotic assays must be performed to ensure that the purification processes efficiently remove these chemicals so that they are at or below the maximum permitted levels and in line with any product-specific regulatory guidelines.
At present, antibiotic residue detection in biological products primarily relies on microbiological, chromatographic, and enzyme-linked immunological techniques. Pharmacopeias prescribe various detection methods tailored to the unique uses and compositions of biological products.
Creative Diagnostics provides highly sensitive antibiotic detection ELISA kits for examining antibiotic residues in biological products' raw materials, intermediate products, and final products. Our testing kits have various advantages:
Please refer to the products list for more information about the our products.
In addition to testing antibiotics in biopharmaceutical products, we also provide ELISA kits for HCP, Protein A/G/L, Benzonase and other impurities residues. Please click here to find more products that interest you.
Reference
| Cat. No. | Product Name | Sample | |
| DEIA040 | Ampicillin | Vaccine | Inquiry |
| DEIABL-QB25 | Benzyl penicillin | Biological samples | Inquiry |
| DEIA6881 | Chloramphenicol | Biological samples, fish, shrimp, eggs, honey, meat (beef, chicken and pork), milk, milk powder, condensed milk and serum | Inquiry |
| DEIA6881V2 | Chloramphenicol | Vaccine | Inquiry |
| DEIA042 | Colistin | Beef, pork, chicken | Inquiry |
| DEIABL-QB20 | Erythromycin | Tissue(muscle), cell supernatant, vaccine, water, honey, milk | Inquiry |
| DEIA047 | Gentamicin | Vaccine, cell culture supernatant | Inquiry |
| DEIA-WZ6884 | High Sensitivity Gentamicin | Cell lysate, urine, serum, recombinant protein, fermentation liquid | Inquiry |
| DEIA048 | Kanamycin | Biological samples | Inquiry |
| DEIA-WZ048V | High Sensitivity Kanamycin | Biological samples | Inquiry |
| DEIA043 | Neomycin | Cell culture supernatant, vaccine, milk | Inquiry |
| DEIA-XYZ35 | Oxytetracycline | Biological samples, honey, butter, fermented milk, feed, egg, cheese, milk, meat, meat products (sausage), fish and shrimp | Inquiry |
| DEIA020 | Streptomycin | Vaccine, cell culture supernatant | Inquiry |
| DEIA-WZ020 | High Sensitivity Streptomycin | Serum, urine, recombinant protein | Inquiry |
| DEIANJ11 | Human Vancomycin | Human serum, plasma | Inquiry |
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