GMP Proteins for in Vitro Diagnostics

GMP, or Good Manufacturing Practice, is a series of strict standards and requirements established to ensure the quality and compliance of the pharmaceutical manufacturing process. GMP proteins usually refer to proteins produced by GMP requirements, which are characterized by high purity, low endotoxin, and low viral load. In the field of in vitro diagnostics (IVD), GMP proteins can ensure the stability, effectiveness, and safety of IVD products. Currently, many GMP proteins have been used as calibrators, quality controls, and production standards to play an important role in the production of IVD kits. These proteins are manufactured under strict quality control and standardized production processes to ensure the accuracy and reliability of the products.

Creative BioMart is committed to providing high-quality, reliable GMP protein raw materials for the production of IVD kits while ensuring the accuracy and safety of the kits. Due to the strict adherence to regulations and standards, our GMP proteins can fully meet the basic requirements of scientific research.

Advantages of Our GMP Proteins

• High Stability

The production process undergoes stability testing and quality control to ensure that GMP proteins maintain stable performance during storage and use, which is conducive to improving the stability and reliability of IVD reagents.

• High Purity

GMP proteins undergo a strict separation and purification process to reduce the interference of other impurities and ensure purity, which is conducive to improving the specificity and sensitivity of IVD reagents.

• Low Endotoxin

Due to the strict control of endotoxin contamination during the production process, GMP proteins have low endotoxin content. This advantage helps to reduce the immune response and non-specific reaction and improve the accuracy of IVD reagents.

• Low Viral Load

GMP proteins are strictly controlled for viral contamination during the production process to ensure that they do not carry any viruses or pathogens, which ensures the safety of the products.

• GMP Compliant

The production process complies with relevant regulations, and certified quality management systems, ensuring the quality and safety of GMP proteins used in scientific research or medical fields.

Role of GMP Proteins in IVD Reagents

• GMP proteins are used as raw materials for antigens or antibodies to produce diagnostic reagents with high sensitivity, specificity, and stability. These proteins are characterized by high purity, low endotoxin, and low viral load, which can ensure the quality and safety of IVD reagents.
• During the production of diagnostic reagents, GMP proteins undergo rigorous isolation and purification to ensure the homogeneity and stability of their composition and properties. These proteins can be used in the production of key raw materials such as enzyme conjugates and immune complexes to produce high-quality IVD reagents.
• For the production of calibrators and QC to assess the performance and accuracy of IVD reagents. The performance and quality of IVD reagents can be better controlled through the use of calibrators and QC produced from GMP proteins.

IVD & GMP Proteins

• Human Immunodeficiency Virus (HIV)
• Varicella-Zoster Virus (VZV)
• SARS-CoV-2
• Allergy

Reasons to Choose Us

• Safety assurance. Our laboratory has a strict quality control system to ensure all experimental procedures and products meet GMP requirements.
• Variety diversity. Our products cover a wide range of high-quality GMP protein products, in addition, we can also provide professional and personalized customized services to meet your research needs.
• One-stop service platform. We will deliver the products quickly and provide professional after-sales service.

Creative BioMart is dedicated to the field of in vitro diagnostics with a wide range of high-quality GMP proteins and related customized services to accelerate the development of disease diagnostics and therapeutic drugs. If you are interested in our services and products, please contact us.