GLP standards for Recombinant Proteins
Refer to adherence to regulatory guidelines ensuring the quality, integrity, and reliability of non-clinical laboratory studies conducted during the production of recombinant proteins using AffiREC technology. Compliance involves strict protocols, documentation, and quality control measures to meet regulatory requirements for safety, efficacy, and reproducibility.
Features
Diagnostics
Recombinant proteins produced under GLP standards using AffiREC can serve as components in diagnostic assays for detecting biomarkers, pathogens, or disease-related molecules.
Biotechnology
GLP-compliant production of recombinant proteins using AffiREC facilitates their use in various biotechnological applications, such as enzyme production, protein engineering, and industrial processes
Regulatory Compliance
Following GLP standards ensures that recombinant proteins produced using AffiREC technology meet regulatory requirements for safety, efficacy, and quality. This is essential for obtaining regulatory approval for their use in research, diagnostics, or therapeutic applications.
Applications
Quality Assurance
GLP standards ensure that all aspects of recombinant protein production, from initial design to final characterization, adhere to rigorous quality control measures, ensuring the reliability and reproducibility of results.
Documentation and Traceability
GLP-compliant processes require thorough documentation of experimental procedures, data collection, and analysis, providing traceability and transparency throughout the production process.
Consistency and Reproducibility
GLP standards promote consistency and reproducibility in recombinant protein production, minimizing variability between batches and ensuring the reliability of experimental outcomes.