Biosafety Testing of Antibody Drugs
Online Inquiry
Biosafety characterization plays a critical role in the development and manufacturing of antibody drugs. It ensures that these therapeutic products are safe for use in patients, mitigates potential risks, and complies with regulatory requirements. At Creative Proteomics, we offer a comprehensive range of biosafety characterization services for antibody drugs. Our services include bacterial endotoxin testing, sterility testing, and mycoplasma testing.
Importance of Biosafety Characterization for Antibody Drugs
Biosafety characterization is imperative for antibody drugs as it addresses potential risks that may arise during the development, manufacturing, and administration of these therapeutics. Antibody drugs are complex biological products, and any contamination or impurities can lead to adverse effects on patients. By conducting rigorous biosafety characterization, potential sources of contamination, including bacterial endotoxins, microorganisms, and mycoplasma, can be identified and eliminated, thereby ensuring patient safety and product quality. Additionally, regulatory authorities such as the Food and Drug Administration and EMA require comprehensive biosafety data for antibody drugs before granting approval for clinical trials or marketing authorization.
Our Biosafety Testing Services of Antibody Drugs
Our experienced team of scientists and technicians are well-versed in the latest regulatory requirements and international guidelines for biosafety testing. We work closely with pharmaceutical and biotechnology companies to help them assess the safety and efficacy of their antibody drugs throughout their development process.
Our biosafety testing services encompass a wide range of assays and tests, including but not limited to:
Our bacterial endotoxin testing service utilizes the Limulus Amoebocyte Lysate (LAL) assay, an industry-standard method for the detection and quantification of endotoxins. By assessing the presence of bacterial endotoxins, we determine potential contamination risks associated with raw materials, manufacturing processes, or final product formulation.
According to the requirements of national pharmacopoeias, each batch of a sterile drug product must be tested and certified as sterile before it can be sold. Therefore, sterility testing is part of the release testing of antibody therapeutic products. We perform sterility testing of antibody drugs in accordance with current regulatory guidelines, industry standards, and best practices. Our testing methodologies include direct inoculation, membrane filtration, and immersion methods.
Mycoplasma detection is an effective means of checking whether the antibody drug is contaminated by exogenous factors, and it is an important quality control way to ensure product quality. Creative Proteomics provides a variety of assays according to the needs of customers at different stages of development, including culture assay, indicator cell assay, nucleic acid assay and ELISA assay. These methods are characterized by fast detection speed, high specificity and high sensitivity, which can help customers effectively detect the biosafety of antibody drugs.
At Creative Proteomics, we understand the criticality of biosafety testing in the development and manufacturing of antibody drugs. Our team is committed to providing accurate and timely biosafety characterization services. For more information or to request our services, please feel free to contact us.
