Mycoplasma contamination is a serious concern in the biopharmaceutical industry as it can compromise the quality and safety of drugs, especially antibody-based therapeutics. At Creative Proteomics, we offer comprehensive Mycoplasma Testing services for antibody drugs. Our testing services aim to detect and prevent mycoplasma contamination, mitigating the potential risks associated with these contaminants.
Why is Mycoplasma Testing for Antibody Drugs Necessary?
Mycoplasma are small bacteria-like microorganisms that lack a cell wall, making them resistant to antibiotics commonly used in traditional bacterial contamination testing. These opportunistic pathogens can potentially infect mammalian cell cultures, including those used for the production of antibody drugs. Mycoplasma contamination can lead to a variety of adverse effects, including reduced product yield, altered growth characteristics, and potential safety concerns for patients using the drugs. Rigorous testing for mycoplasma contamination is essential to comply with regulatory requirements and ensure patient safety. By detecting and eliminating mycoplasma at an early stage, potential risks associated with contamination can be mitigated, safeguarding your pharmaceutical product's efficacy and reputation.
Our Mycoplasma Testing Services
Our testing methodology involves a combination of microbial culture, polymerase chain reaction (PCR), and enzyme-linked immunosorbent assay (ELISA) techniques. This multi-pronged approach allows us to detect and quantify the presence of Mycoplasma contaminants in both cell cultures and the final drug product.
- Mycoplasma identification
Using advanced molecular techniques and validated testing methods, we provide highly accurate mycoplasma identification services. Our experts employ a range of detection methods, including PCR, DNA sequencing, and nucleic acid staining, to determine the presence and species of mycoplasma contamination.
- Mycoplasma quantification
Quantifying mycoplasma contamination is crucial for assessing the level of contamination and implementing appropriate corrective actions. Our testing services employ qPCR technology to determine the number of mycoplasma colony-forming.
Mycoplasma Testing Services Processes
Creative Proteomics provides customers with a one-stop shop for testing services. All you need to do is to send us the samples to be tested, and we can help you achieve rapid mycoplasma detection and result analysis in a short period of time. Here is our specific service process:
- Upon receipt of samples, we use microbial culture techniques to isolate and culture mycoplasmas. This step determines the presence of live mycoplasma contaminants.
- PCR was utilized to detect the presence of mycoplasma DNA in the samples.
- ELISA technology was used to detect and quantify mycoplasma-specific antibodies in samples. This provides additional verification and confirmation of mycoplasma contamination.
- A detailed report of the results is provided to the client. The report includes quantitative data on the specific mycoplasma species detected, the level of contamination, and recommendations for further action to address the contamination.
Our Mycoplasma Testing Services Features
Creative Proteomics is committed to utilizing our reliable testing services to ensure the safety and efficacy of your antibody therapeutic products. For more information or to request our services, please feel free to contact us.
