Profacgen provides impurity testing services for the pharmaceutical industry to help ensure the quality and safety of pharmaceutical products, especially when accuracy and efficiency are critical. We provide a comprehensive pharmacopoeia analysis to detect mycoplasma and bacterial contaminants, as well as in vivo, in vitro and biochemical virus detection analysis. Our experts can design and develop an appropriate contamination test plan for your biological products, and select available and customized analysis methods that meet your specific needs. We support impurity testing at all stages of the process.
The contamination of bacteria and fungi will make the cell experiment unable to continue; Mycoplasma contamination is not easy to detect, but it will directly affect the state of cells inadvertently. Therefore, it is very important to detect the sterility of cultured cells and final products. We provide you with bacteria, fungi, mycoplasma testing services.
Endotoxin is a component of the cell wall of Gram-negative bacteria, which is toxic to the host. Therefore, it is necessary to detect and control the content of endotoxin, so as to avoid adverse reactions of the host when recombinant protein is used in animal experiments, which will affect the experimental results. Relying on mature technology and perfect testing equipment, we are able to provide endotoxin testing services for customers from research, clinical, environmental laboratories and pharmaceutical or medical device industries.
Many biological drugs (antibodies, vaccines, recombinant proteins, etc.) are synthesized by biological systems. Although a variety of purification methods are used, there may be a small amount of host protein residues (HCP) in biological drugs. HCP in biological products, as a foreign protein, may induce immune response in varying degrees, and eventually lead to allergic reactions or other adverse reactions. Therefore, it is necessary to establish an appropriate method to detect HCP to monitor the quality of biological products. For accurate detection of host proteins that may remain in biological drugs, we provide 2D DIGE based HCP antibody effectiveness detection service. Firstly, we extracted the whole protein of the host cells and labeled the whole protein and the whole protein antibody with different fluorescence. Then, the whole protein of host cells was efficiently separated by 2D technology, and the 2D gel was scanned in the laser scanner to obtain the whole protein scanning map of host cells on the channel. Then the protein on the 2D gel was transferred to the membrane, the membrane was incubated with the whole protein antibody, and the membrane was scanned with a laser scanner. Because of the binding between antibody and antigen, the scanning image of antibody protein on the corresponding channel can be obtained. By comparing the two scanning images, the coverage of antibody to total protein can be determined through software analysis.
Biological products, such as recombinant protein drugs, antibody drugs, vaccines and so on, are produced by continuous passage of cell lines. Although the purification process is strict, the DNA fragments of host cells may still remain in the products. The size and composition of these residual DNA fragments are uncertain, and the potential risk is uncertain, which may bring infectious, or tumorigenic, or immunogenic increase, or mutagenic risks. Therefore, the drug regulatory authorities of various countries have very strict requirements on the limit of DNA impurities, which is an important safety and quality control link of biological agents. In addition, all kinds of antibiotics and proteases produced by microbial fermentation also need to detect DNA residues from host cells. qPCR method is the standard method of host residual DNA in biological products. qPCR has the advantages of high sequence specificity, high sensitivity, good reproducibility and less human interference. It can provide a reliable detection method for biopharmaceutical industry in process research and product quality control. Therefore, qPCR will become an internationally recognized method for detection of residual DNA.
In addition, we can provide other tests such as process and product related impurity detection. If you are interested in our residual contamination and impurity Testing, Profacgen looks forward to cooperating with you.
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