Quality
e-Proteins: A Leader in Binding Protein Purification and Quality Assurance
E-Proteins stands out in the life sciences industry with over three decades of expertise in purifying and ensuring the quality of binding proteins like avidin and its derivatives. The company has continuously evolved its production process, integrating technological advancements and leveraging extensive experience. This evolution reflects a commitment to excellence and innovation in protein extraction.
Advanced Technology and rigourous Quality Control
E-Proteins’ specialization in protein binding is enhanced by proprietary technology. This technology, developed by Belovo’s R&D department, is a key asset. As a result, E-Proteins achieves more than 99% purity in products like avidin, Neutralite Avidin, Ultracoat50, and Ultracoat70. Additionally, the company implements strict quality control at every production stage. This ensures every product upholds the company’s high standards.
Adherence to Global Standards and Certifications
E-Proteins demonstrates a strong commitment to global standards. The company proudly holds the ISO 9001:2015 certification. This reflects its dedication to top-quality operations. Additionally, E-Proteins performs detailed analyses on each production batch. This careful process guarantees product quality. They ensure their products meet specific requirements and exceed 99.5% purity. At the same time, they maintain optimal solubility. This thorough approach in quality control shows E-Proteins’ dedication to excellence.
Certification and Compliance for the highest avidin quality
Furthermore, E-Proteins plays a crucial role in avidin certification in the pharmaceutical and diagnostic sectors. The company’s production of avidin strictly follows ISO-9001:2015 standards, ensuring high-level quality management. The GMP avidin certification, approved by the Belgian National Health Agency, highlights the company’s dedication to providing a drug substance that aligns with its intended use.
Virus Safety Measures and Sterile Certification
E-Proteins undergoes yearly audits by the National Veteran Agency to ensure regulatory compliance due to the animal origin of avidin. The company has developed several methods for virus inactivation and removal, selecting three to maintain maximum product activity. The Virus Inactivation/Removal Certification process is rigorous and lasts about nine months.
In pursuit of sterile certification, E-Proteins collaborates closely with specialized companies, ensuring that the certified sterile avidin meets the highest industry standards. E-Proteins pharmacists oversee the release of the certified sterile avidin as a Drug Product, enhancing its suitability for injectable applications in clinical trials and ensuring adherence to the highest safety and efficacy standards.
Conclusion
In summary, E-Proteins firmly establishes itself as a leader in the binding protein sector, demonstrating an unwavering dedication to maintaining the highest quality standards in avidin production. The company’s rigorous certification processes and commitment to providing exceptional products and services emphasize its role in advancing the life sciences sector.